Reporting to the General Manager (Singapore) you will play a crucial role in the continued development, management and leadership of this state of the art in vivo / ex vivo facility. This operation is focused on the development of novel and scientifically robust approaches that provide reliable scientific evidence and data, of the highest quality, using a systems biology-based approach. This helps us to understand mechanisms of disease observed in animal models and then translate these observations to human physiology – validating scientific concepts and developing new tools for future research.

Using highly advanced in vivo / ex vivo systems and technology you will have operational responsibility for the laboratories and the quality of work performed.  You will also be responsible for the delivery of results, the quality of the scientific data produced, managing priorities and facility resources, to ensure maximum efficiency.

The existing team consists of professionals with scientific, technology, managerial and support responsibilities. The company is only the 5^th inSingapore to achieve Good Laboratory Practice accreditation, and the only one in 2011, with further accreditation gained in 2012 from the AAALAC (“Association for Assessment & Accreditation of Laboratory Animal Care”).

You will be responsible for leading, developing and motivating a high performing BioResearch team with responsibility for their performance and development.  Utilising excellent communication skills, at all levels, you will lead and direct the work of others, maintain a high level of customer focus and ensure that those reporting directly to you have the necessary direction and leadership at all times.  Your aim is to deliver scientific data of the highest quality, leading the established in vivo team and establishing and developing the ex vivo group.

You will have significant direct and indirect line management and capital expenditure responsibility, leading and developing a high performance scientific team, empowering them to deliver state of the art scientific data. You will be expected to utilise existing technologies and methodologies as well as to be involved in the development and assessment of new technological advances in in vivo / ex vivo research.

You will be a proven leader, with strong management skills in a matrix environment, the ability to motivate others, think strategically, be an excellent communicator and have the awareness to invest in and develop positive relationships with stakeholders in many countries. You will build and lead teams and operate within an environment of entrepreneurial freedom and decision making, building multi-disciplinary and multi-cultural teams.

You will help to evaluate all methodology, ensure best practice and maintain a high level of awareness of new technological advances. With a high level of emotional intelligence and an entrepreneurial outlook you will be comfortable listening to the opinions of others, but also making your own decisions.

This is an exciting opportunity to join a highly successful global business, within a leadership capacity, in a highly visible capacity where the long term career prospects are varied and exceptional.

For further information or a discussion in complete confidence, please contact Dr Grant Coren,

Pharma-Search Ltd – grant@pharma-search.co.uk, telephone: + 44 (0) 1442 345 340.

Reporting to the General Manager (Singapore) you will play a crucial role in the leadership of all key in vivo projects, managing and leading highly qualified study directors.  This operation is focused on the development of novel and scientifically robust approaches that provide reliable scientific evidence and data, of the highest quality, using a systems biology based approach.  This helps us to understand mechanisms of disease observed in animal models and then translate these observations to human physiology – validating scientific concepts and develop new tools for future research.

Using highly advanced in vivo / ex vivo systems and technology you will provide scientific expertise and guidance to the General Manager. You will bring a high level of scientific expertise and experience in developing targeted in vivo models to understand specific disease mechanisms in areas such as Lung Cancer and Chronic Obstructive Pulmonary Disease (COPD). You will be expected to interpret complex data from both in vivo and ex vivo methodology. You will have excellent written and oral communication skills and will work closely with scientific leaders, regulatory groups and senior management.

You will be responsible for leading, developing and motivating a high performing BioResearch team, working directly with the Biological Systems Research group in Switzerland, responsible for the establishment and validation of novel in vivo models.  Your aim is to deliver scientific data of the highest quality, leading the development of new models to enhance disease understanding.

You will have direct and indirect line management responsibility in a matrix environment, leading strong multi-disciplinary and multi-cultural scientific teams, ideally with the ability to manage through influence, with excellent problem solving skills and leadership capability, whilst developing excellent relationships with stakeholders in all countries.

You will have the ability to motivate others, think strategically, be an excellent communicator and possess the awareness to invest in and develop positive relationships at all levels, with a high level of comfort with senior management.

Your success will be linked to your ability to develop and lead a high performing team(s) delivering science and scientific data of the highest standards, providing direction, leadership and vision. You will also be expected to gain the respect of your scientific peers and external stakeholders, such that you are recognised as a global expert within the development and use of in vivo models for Lung Cancer and COPD.

This is an exciting opportunity to join a highly successful global business, within a leadership capacity, in a highly visible capacity where the long term career prospects are varied and exceptional.

For further information or a discussion in complete confidence, please contact Dr Grant Coren,

Pharma-Search Ltd – grant@pharma-search.co.uk, telephone: + 44 (0) 1442 345 340.

Our client is a leading global CRO, a company that has enjoyed a sustained period of growth and success.  This has been driven by the successful delivery of clinical trials of the highest standards, through their people, innovation and transparency. Our client currently operates:

• Across all phases of clinical development
• Across all therapeutic areas
• Through combining global, international and local operating expertise
• Across over 90 countries with approximately 5000 personnel
• With over 30 years’ experience
• With a level of creativity and efficiency to add value to their sponsors and patients

As Executive Vice President, EAPA you will be expected to provide leadership and overall responsibility operationally for the highly successful Product Registration group across Europe, Asia Pacific and Africa (EAPA). You will be responsible for the further growth of
existing groups and the continued development of new markets and teams.

Reporting to the Chief Executive Officer, you will perform as a key member of the executive leadership team, leading the Clinical Operations and Project Management groups operationally and strategically.  Working with your senior management team you will help to define the long term strategy, vision, objectives, plans and programs for assigned markets and business functions.  You will also play a key role in integrating these into the overall corporate objectives, plans and programs to develop a single global focus.

The Executive Vice President, EAPA will manage the Product Registration group to address the needs of the company’s clients, takeholders, industry groups and employees in a responsible and ethical manner with due regard to social responsibilities.

The Executive Vice President, EAPA will assist, at all times, in promoting corporate values of the highest standards, developing, supporting and sponsoring activity that creates a work environment designed to attract and retain the best people, thereby ensuring the continued delivery of services that exceed customer expectations.

The successful candidate will have an advanced degree (Masters or PhD preferred) with substantial executive management experience and
an in-depth understanding of the CRO sector. The Executive Vice President, EAPA will have a strategic approach with excellent business acumen and the ability to align strategies and recommendations with Clinical Operations and Project Management objectives. You will have an adaptable and flexible style of collaborating with key stakeholders in establishing the vision, setting the direction as well as having the ability to quickly gain credibility, influence and partner with business leaders and customers.

This is an extremely visible role, with a high level of responsibility, autonomy and influence, with an equally significant level of accountability. Corporate growth and success will be mirrored by your own personal and professional growth within this career shaping role.

 If you are interested in this role, please visit our website www.pharma-search.co.uk  or telephone Dr Grant Coren in strictest confidence on 01442 345 340.  Alternatively, please send your CV to grant@pharma-search.co.uk. 

Founded in 1974, by Bernard Jambon and JL Menard, MAPI Group has grown both organically and through acquisition over the past 35 years. Today, MAPI Group employs over 450 people in North America, Europe and Asia.

MAPI is structured into three divisions which comprise a number of separate legal entities:

Late Phase CRO

• Phase IV Clinical Trials
• Observation and Registry studies
• Risk Management Plan
• Direct Patient Management

Strategic Consulting

• Market Access
• Patient Reported Outcomes
• Cost effectiveness evidence generation

Linguistic Validation

• Patient reported and clinical assessments for appropriate cross-cultural use and interpretation

A separate entity, the MAPI RESEARCH TRUST is a non-profit association concerned with the promotion of PRO evaluations and worldwide distribution of information concerning these measures.

The MAPI Group consists of a number of companies; all dedicated to providing unique solutions to aid and improve drug development to meet patient and market needs.

MAPI group anticipates change and develops services and solutions designed to respond to a full range of evaluation needs.  Their experience comes from extensive partnerships with industry, health authorities, investigators and patients.

MAPI Group’s strength lies not only in its breadth of experience and expertise, but in the total dedication to research conducted by dynamic, specialised teams, backed up by powerful technical and logistics support.

Late Phase CRO

REGISTRAT-MAPI

REGISTRAT-MAPI is the industry’s largest clinical research organisation dedicated solely to “real world” clinical research. Successfully drawing upon their strategic and operational expertise to design and conduct global late phase studies and to develop partnerships with biopharmaceutical and medical device company clients.

As the demand for Late Phase development grows significantly both in size and complexity, REGISTRAT-MAPI continues to lead the way through innovation in registries, safety studies and product utilisation studies.

With its head office in Lyon, France and further operations throughout Europe and United-States, REGISTRAT-MAPI specialise, among others, in:

• Phase IV Studies
• Pharmaco-epidemiological Studies
• Risk Management Programs
• Disease and Product Registries

Providing a complete Spectrum of Integrated Late Phase Services:

• Strategic Consulting Services
• Risk Evaluation and Medical Strategies
• Optimal Study Design
• Multidisciplinary Excellence in Patient Reported Outcomes
• Multi-country Regulatory Management & Ethical Submissions
• Accurate Implementation Process & Project Management
• In Fine PHARMA : network of 2000 pharmacists in France
• Remote and on-site monitoring
• Tailored integrated EDC & Call Centre solutions
• Data Management Services
• Late Phase oriented Statistical Methods
• Medical Writing, Publications
• Integrated Technologies

Evidence-based research is increasingly desired by pharmaceutical companies due to recent FDA and EMEA initiatives as well as changing requirements from health care payers (government and private insurers). The market for phase IV post-approval research is estimated at $12 billion and growing at 23% per year . REGISTRAT-MAPI is currently the market leader in France and a major player in Europe in Late Phase studies (Phase IV and Observational).

Given REGISTRAT-MAPI’s leading position in Europe, unique range of expertise and experience already gained through its numerous key clients, the Group is well positioned to win large scale international studies, negotiate preferred provider agreements and become a leading global player in the Late Phase segment.

Context of the Role

It is widely recognised that the demand for CRO services will continue to grow over the coming years with some predicting that this will be as much as 20% per annum .
The market for Phase IV post-approval research is estimated at $12bn and growing by 23% per year .
REGISTRAT-MAPI is uniquely positioned to take advantage of this growth for several reasons:

• They are the industry’s largest clinical research organisation dedicated solely to “real world” clinical research and have the expertise and infrastructure required to perform large, multinational observational studies and registries.
• They have more than two hundred specialist employees in 7 locations and have successfully conducted studies in over 32 countries.
• MAPI Group has pursued an acquisition strategy and partnered with companies that have enabled them to incorporate many ancillary services to their product and service offering without compromising their quality.
• REGISTRAT-MAPI has an enviable track record in the design and successful conduct of late phase studies which provides an excellent platform for further new business generation.
• Experienced and proven track record in assisting clients through the process and all the associated requirements for EMA and FDA registration.
• Access to other MAPI Group company expertise provides a rich source of complementary capabilities.

For further information please review the company and group websites at:
www.registratmapi.com
www.mapigroup.com

Job Description

Primary Purpose of the Job

Essential Functions:

• Reporting to the Executive Director, Business Development, Europe you will serve as overall business developer, account relationship manager and strategic business partner for new and established account(s) in your region.
• You will be responsible for developing and expanding new business opportunities within allocated account(s) to include developing and overseeing the sales strategy for assigned clients, managing the sales process and coordinating with Project Management to ensure client satisfaction.
• The focus will be on the United Kingdom and Nordics primarily.

Accountabilities:

• Contribute to REGISTRAT-MAPI’s growth in supporting the company’s objectives.
• Develop and communicate in depth pipeline and account analysis and territory development.
• Achieve individual goals and support team goals.
• Work closely with Executive Director, Business Development to ensure continuity of messages to clients and provide guidance to team members to resolve client issues and questions.
• In conjunction with Executive Director, Business Development, develop and maintain a plan for the expansion of business in the respective accounts.
• Develop and maintain a comprehensive business plan for all activities within your area of responsibility.
• Secure preferred status for REGISTRAT-MAPI in target accounts, leveraging creative deal structures as appropriate and negotiating mutually acceptable terms with support of the contracts team. Participate in customer oversight committee(s) as appropriate.
• Lead client services proposal teams and bid-defence teams and/or act as REGISTRAT-MAPI senior executive as appropriate.
• Ensure that all proposal/contract details, clients’ meetings, RFP information and relevant updates of the respective team members are captured and maintained within Sales force.
• Contribute to the annual forecasting process in collaboration with the Executive Director, Business Development and attend the respective planning meetings.
• Demonstrate cross functional collaboration with other Group companies.
• Cultivate strong, long-term relationships with key decision-makers within accounts and develop deep knowledge of the account organisations.
• Identify and respond to client needs in order to define potential REGISTRAT-MAPI opportunities.  Ensure appropriate strategy and solution is proposed to the client.
• Work with Project Directors and Function Managers to identify most appropriate sales team and prepare presentation. Educate team participants in client culture, operational needs, methods and sales techniques required to close the sale.
• Coordinate with Project Managers, Project Directors and Executive Director to escalate and quickly address client issues and concerns.
• Seek input from Project Managers and Project Directors, as required, to proactively address Changes In Scope (CIS), new opportunities or customer dissatisfaction.
• Work with Project Managers, Project Directors and CRU Management to ensure CIS’s are appropriately negotiated with the client.
• Maintain high visibility within client organisations.
• Monitor client satisfaction through regular formal and informal surveys.

Personal Style

• A flexible and adaptable team player with a strong sense of fun and a positive, “can do” attitude.
• Creative and prepared to think outside the box; willing to take the initiative and to present solutions rather than problems.
• Thrives under pressure while maintaining a high level of personal and professional integrity.
• Clear desire and ambition for success, comfortable making decisions and prepared to make the personal commitment to ensure success.

Person Specification

• A minimum of a Bachelor’s degree (or equivalent) and a higher level degree (Master or PhD, MBA) desirable.
• An established senior level network with some of the world’s top 25 Pharmaceutical and Biotechnology companies.
• Proven track record of identifying and securing full service business in top tier accounts.
• Experience in developing new Late Phase business opportunities.
• Analytical approach to business.
• Skilled in performing presentations and leading meetings.
• Demonstrable competency in sales or business development preferably for a Contract Research Organisation or company providing services to the healthcare industry.
• Fluent written and spoken English language skills.
• A solid understanding of the clinical process (Phase II – IV) coupled with a desire to develop existing knowledge.
• Knowledge of EMA regulated drug development process helpful.
• Good skills in Microsoft PowerPoint, Excel, Word, etc.

Competencies

• Sound understanding of the principles of Key Account Management
• Strong detail orientation and an ability to work creatively in a fast-paced environment.
• Excellent planning/organisational skills and ability to prioritise and multitask.
• Results orientated.
• Responsive and strong customer focus.
• Convey information in a clear, concise, and accurate manner.
• Display an open and flexible attitude, with a desire to support others and genuinely operate within a team structure .
• Demonstrate professionalism and presents a positive image of REGISTRAT-MAPI.  Understand the customer’s needs before presenting a solution.  Effectively handles challenging customer situations.  Maintain a high energy level when interacting with customers.
• Develop and ensure compliance with project timelines and budgetary requirements.  Understand and demonstrate knowledge of milestones and timelines.  Prioritise time effectively based on project and employee needs.
• Demonstrate honesty and integrity in dealing with others. Work effectively with different types of people.
• Proactively attitude and drive to develop senior level business relationships.
• Consistently proven sales and negotiation skills.
• Ability to work with other Senior Executives to facilitate joint customer development.

Package

• Competitive base salary commensurate with experience
• Commission and Bonus Plan, with stretch targets, and the potential to significantly exceed base salary through the meeting of targets and objectives
• Holiday – 28 days per annum
• Attractive pension
• Car Allowance
• Private health for employee and dependants
• Life assurance and disability insurance cover

PRA International is one of the world’s leading Global Clinical Research Organisations.

With an established presence, spanning more that 30 years, they have enjoyed continual growth and success, currently employing 3,200 staff globally.

PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge. This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers.

PRA International – History

Established in the late 1970’s with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA.

In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location.

1996 saw the company name change to PRA International as the company moved towards becoming a global CRO with 333 employees.

In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International’s clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory. Additionally they gained a Phase I facility.

In 1999, PRA acquired Valorum (UK) Ltd, based in Reading, UK. This acquisition enhanced their regulatory expertise and expanded PRA’s trial management footprint in Europe.

In 2000, PRA acquired ARCAM, an international CRO based in Paris, France. This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance. This enhanced PRAs European footprint to in excess of 250 employees.

In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management.

In 2002, PRA acquired CroMedica, a CRO headquartered in Canada with key expertise in the CNS therapeutic area and global operations. Several of their offices now represent PRA in Victoria, British Columbia; San Diego, California; Sao Paulo, Brazil; Johannesburg and Cape Town, South Africa; and Sydney, Australia.

In November 2004, PRA became a publicly traded company on the NASDAQ exchange.

In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services.

In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany. Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA’s Early Development Services plan to further strengthen its position as an industry leader.

PRA returned to being a privately held company when it was reacquired by Genstar Capital, LLC in December 2007. Genstar had been PRA’s largest investor before the initial public offering in 2004.

PRA International’s mission: ‘Our people commit to provide innovative solutions that our clients rely upon to introduce new drugs and to improve lives’

PRA International – Core Values

• Unquestionable ethics and integrity
• Consistent and measurable quality in all they do
• Outstanding service and flexibility to meet customer requirements
• Commitment to staff development and collaboration
• Demonstrated technical and therapeutic excellence throughout the company

PRA International – Key Services

Trials Management Services

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification
• Investigator handbook and meetings
• Investigator site management
• Investigator site monitoring
• Medical monitoring and drug safety
• Data management
• Analysis and reporting
• Medical and scientific publications
• Regulatory filings

Early Development Services

• First in man studies
• Single and multiple dose safety and tolerability studies
• Food effect
• Proof of concept studies
• Interaction studies with drugs and food
• Mass balance / ADME studies
• Micro dosing studies
• Single and multiple dose bioavailability studies
• QTc – prolongation and intensive ECG studies
• PK studies in renally impaired patients
• PK studies in hepatically impaired patients
• Special population studies
• Special formulations
• Vaccine studies
• Studies with biotechnology-derived therapeutic products

Late Phase Services

• Safety surveillance
• Post-authorisation safety studies (PASS)
• Restricted access programs
• Retrospective studies

Drug Safety Management

• Reporting of serious adverse events
• Processing and reporting of adverse drug reactions (ADRs)
• Periodic safety update reports
• Safety and Pharmaco-Epidemiological Studies
• Global database pooling and integrated summaries of safety
• Consulting and system analysis

Electronic Regulatory Submissions

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification

For further information, please go to www.prainternational.com

Primary Purpose of the Role

Responsible for clinical operations activities and staff within the unit(s). Mentors and leads the clinical operations management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices.  Provides leadership in the implementation of PRA’s quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy. Provides strategic direction to the Clinical Operations department.

Accountabilities (Responsibilities)

•      Sets overall direction, strategy and performance standards for multiple job disciplines to ensure that project profitability targets are achieved
•      Schedules and reviews project tasks to ensure high quality product is delivered on time and within budget
•      Ensures services provided to clients are compliant with PRA’s policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements
•      Manages operation budget for the unit (s)
•      Mentors and develops employees to expand employee performance levels and ensure retention of high performing PRA employees
•      Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
•      Accurately projects resource needs to ensure timely hiring of clinical operations staff
•      Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/project objectives are achieved
•      Establishes processes and participates in PRA’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
•      Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
•      Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic specific nuances while identifying potential impacts of the same to budget
•      Participates in client presentations and/ or bid defence meetings, as required
•      May function as legal representative for PRA in selected countries as appropriate
•      Broader focus on moderate to complex projects. Less supervision by VP or Exec Director
•      Strategic focus for all projects independent of degree of complexity. Works under general guidance by VP, but minimum oversight required

Qualifications

•      Undergraduate degree, or its international equivalent, in clinical science or health-related field from an accredited institution, or equivalent work experience required
•      Advanced degree, or its international equivalent, preferred
•      Extensive experience using computerised information systems required, experience with PC-Windows, word processing, and electronic spreadsheets required
•      Substantial clinical trials development experience is required
•      International clinical development experience preferred
•      Substantial experience supervising or managing professional staff in a clinical research environment required
•      Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
•      Read, write and speak fluent English, fluent in host country language

Package – dependent upon location

•      Competitive basic salary
•       Bonus
•      Company Car or Car Allowance
•       5% non-contributory pension
•       Private healthcare
•       Life Assurance (4 X base salary)
•       25 days holiday

If you are interested in this role, please visit our website www.pharma-search.co.uk  or send your CV to grant@pharma-search.co.uk

PRA International is one of the world’s leading Global Clinical Research Organisations.

With an established presence, spanning more that 30 years, they have enjoyed continual growth and success, currently employing 3,200 staff  globally.

PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge.  This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers.

PRA International – History

Established in the late 1970’s with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA.

In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location.

1996 saw the company name change to PRA International as the company moved towards becoming a global CRO with 333 employees.

In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International’s clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory.  Additionally they gained a Phase I facility.

In 1999, PRA acquired Valorum (UK) Ltd, based in Reading, UK. This acquisition enhanced their regulatory expertise and expanded PRA’s trial management footprint in Europe.

In 2000, PRA acquired ARCAM, an international CRO based in Paris, France.  This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance.  This enhanced PRAs European footprint to in excess of 250 employees.

In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management.

In 2002, PRA acquired CroMedica, a CRO headquartered in Canada with key expertise in the CNS therapeutic area and global operations. Several of their offices now represent PRA in Victoria, British Columbia; San Diego, California; Sao Paulo, Brazil; Johannesburg and Cape Town, South Africa; and Sydney, Australia.

In November 2004, PRA became a publicly traded company on the NASDAQ exchange.

In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services.

In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany.  Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA’s Early Development Services plan to further strengthen its position as an industry leader.

PRA returned to being a privately held company when it was reacquired by Genstar Capital, LLC in December 2007. Genstar had been PRA’s largest investor before the initial public offering in 2004.

PRA International’s mission: ‘Our people commit to provide innovative solutions that our clients rely upon to introduce new drugs and to improve lives’

PRA International – Core Values

• Unquestionable ethics and integrity
• Consistent and measurable quality in all they do
• Outstanding service and flexibility to meet customer requirements
• Commitment to staff development and collaboration
• Demonstrated technical and therapeutic excellence throughout the company

PRA International – Key Services

Trials Management Services

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification
• Investigator handbook and meetings
• Investigator site management
• Investigator site monitoring
• Medical monitoring and drug safety
• Data management
• Analysis and reporting
• Medical and scientific publications
• Regulatory filings

Early Development Services

• First in man studies
• Single and multiple dose safety and tolerability studies
• Food effect
• Proof of concept studies
• Interaction studies with drugs and food
• Mass balance / ADME studies
• Micro dosing studies
• Single and multiple dose bioavailability studies
• QTc – prolongation and intensive ECG studies
• PK studies in renally impaired patients
• PK studies in hepatically impaired patients
• Special population studies
• Special formulations
• Vaccine studies
• Studies with biotechnology-derived therapeutic products

Late Phase Services

• Safety surveillance
• Post-authorisation safety studies (PASS)
• Restricted access programs
• Retrospective studies

Drug Safety Management

• Reporting of serious adverse events
• Processing and reporting of adverse drug reactions (ADRs)
• Periodic safety update reports
• Safety and Pharmaco-Epidemiological Studies
• Global database pooling and integrated summaries of safety
• Consulting and system analysis

Electronic Regulatory Submissions

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification

For further information, please go to www.prainternational.com

Primary Purpose of the Role

Responsible for clinical operations activities and staff within the unit(s). Mentors and leads the clinical operations management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices. Provides leadership in the implementation of PRA’s quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy. Provides strategic direction to the Clinical Operations department.

Accountabilities (Responsibilities)

• Sets overall direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
• Mentors and develops employees to expand employee performance levels and assure retention of high performing PRA employees
• Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
• Establishes processes and participates in PRA’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
• Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
• Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic specific nuances while identifying potential impacts of the same to budget
• Participates in client presentations and/ or bid defense meetings, as required
• May function as legal representative for PRA in selected countries as appropriate
• Broader focus on moderate to complex projects. Less supervision by VP or Exec Director
• Strategic focus for all projects independent of degree of complexity. Works under general guidance by VP, but minimum oversight required

Package

• Competitive basic salary
•  Bonus  Company Car or Car Allowance
•  5% non-contributory pension
•  Private healthcare
•  Life Assurance (4 X base salary)
•  25 days holiday

If you are interested in this role, please visit our website www.pharma-search.co.uk  or send your CV to grant@pharma-search.co.uk

• To provide global leadership across feasibility with a focus on improving the value delivered to clients, enhancing quality and performance of service deliverables whilst ensuring operating costs are controlled.
• Provide Strategic and tactical leadership to the global feasibility team, the investigator database team and the patient enrolment and recruitment Group.
• Effectively communicate and promote cross functional relationships to ensure relevant input to project strategies, especially regarding feasibility.
• Ensure that the global feasibility group delivers appropriate site and country distributions that lead to successful project delivery.
• Ensure that the global feasibility and patient enrolment and recruitment groups assist in the design of innovative, but practical and fiscally responsible strategies for inclusion in relevant business development documents and for use in the successful implementation, conduct and delivery of clinical trial programs for clients.
• Ensure the global feasibility group delivers quality information to internal and external customers globally in line with challenging timelines.
• Engage with project teams at key time points in the project lifecycle to provide updated data, and other relevant information to further enhance the ability of the team to be successful in their implementation and conduct of a clinical trial.

Key Success Factors

•  Ability to reorganize and craft a busy feasibility.
•  Ability to work within a Global environment and with the Business Development team coordinating and preparing for bid defence meeting.
•  Participate in bid defence meetings as required
•  Document and track feasibility study results for future use.
•  Ability to clearly articulate and develop a feasibility philosophy.

Key Functional Responsibility

 *Asterisks mark essential functions

• Recognise, exemplify and adhere to the company’s values which centre around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.          

 Clients – Delivery to Customers, Building Relationships

•  *Present a high profile role within the organisation always displaying a positive attitude and offering constructive input as required
• *Provide the experience and act as Senior Sponsor on proposals as appropriate
• *Serve as a liaison with clients on significant project developments and new business as appropriate
• *Provide strategic direction to business development plans and support business development with proposals, bid defences and additional client meetings to ensure growth in business across the company.
• *Oversee management of projects globally as assigned/appropriate, ensuring high standards of client satisfaction, quality, and efficiency are maintained.
• *Act as Senior Sponsor for clients, member of OMT / Executive Committees as applicable
• Garner client feedback and ensure client satisfaction across the range of services provided by business unit

 Performance – Personal Effectiveness, Commercial Awareness, Robust Thinking

•  *Lead development of a global operating framework and objectives for assigned business unit to drive global consistency of service deliverables and enhance quality and performance
• *Create performance benchmarks and targets to provide transparency to business unit performance  to Executive Management and support targeted improvements
• Lead the development of a Feasibility function that will support improved site productivity, quality and performance across managed trials
• Implement a framework for organisational learning and knowledge management
• *Enable the company to operate more effectively in risk sharing and fixed price partnership models through driving innovation across assigned business unit
• *Lead the development and growth of Global Feasibility as a profit centre within Clinical Research
• Liaise and take the lead with other business units/managers to improve the effectiveness of the organization
• Effectively manage change within business unit/company in a positive manner
• *In cooperation with Division Vice Presidents, develop and maintain budgets to meet annual targets.
• Audit budgets to ensure fiscal management.
•  Institute cost control measures as needed.
•  Notify executive management of budgetary issues
•  Integrate acquisitions/new department/new offices as required
• Collaborate closely with the support departments of Facilities/HR/IT and Finance on actives that effect the business and manage the business function as required
• *Forecast business unit needs for staff, monitor utilization, and take action when required to meet targets.
• Initiate or lead multiple company and or business unit initiatives
• *Ensure oversight of the quality specification(s) within business unit
• Manage complex assignments in a variety of areas of responsibilities, simultaneously
• Escalate as appropriate to Executive Management issues and appropriate resolution plans
• Ensure appropriate project(s) profitability inclusive of optimising staff utilisation / recovery
• Control and delivery of target budget for business unit
• Assess and assist VPs/Directors with study and departmental metrics as applicable
• *Ability and willingness to travel approx. 25%-30% of the time (international and domestic)
• Other duties as assigned

People – Leadership, Teamwork, Energising and Developing Others

• Actively participate in the selection and recruitment of suitable and qualified staff (Director level and above)
• Ensure all necessary training is provided to staff in the business unit to improve their job performance and knowledge
• - Work with Corporate Training to develop program
• - Measure effectiveness and institute remedial actions as needed
•  Ensure business unit staff operate in a professional and client orientate manner.
•  Ensure global staff turnover levels are kept < 15%.
•  *Focus on project delivery for studies in the planning, patient enrolment and recruitment/retention phase; keep senior management informed of project status in relation to quality, cost and timelines as part of the governance process.
•  Demonstrate development, motivation and mentorship of Directors and above in business unit.
•  Lead succession planning and development of staff across Global Feasibility.
•  Support/conduct performance appraisals and assign responsibilities as appropriate for these individuals.

Person Specification/Experience

 The successful candidate is likely to have the following background and personal qualities:

•  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• US/LATAM/CAN: At least 15 years of global Clinical Research Experience; previous experience at VP or equivalent level is desirable.
• EU/APAC: Expert with comprehensive experience of global Clinical Research Experience, previous experience at VP or equivalent level is desirable.
• Ability to provide senior level leadership to all aspects of Global Feasibility management
• Proven track record of successfully managing directors/managers and delivering projects on time, to budget and the required quality
• Proven track record of positive and significant interaction with all levels of staff
• Proven track record of leading high profile initiatives
• Ability to liaise successfully with all levels of management, vendors, and clients
• Prior experience of managing similar functions, preferred
• Excellent organisational and communication skills
• Proven track record in successfully managing change

Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.

Education Requirements

•  University/Bachelors Degree in medicine, science or equivalent degree/experience
•  Advanced or medical degree preferred
•  The package is negotiable, based upon the level of experience of the individual.

 If you are interested in this role, please visit our website www.pharma-search.co.uk  or send your CV to grant@pharma-search.co.uk

Theorem Clinical Research (formerly known as Omnicare) is one of the industry’s leading full-service, global CROs, providing core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics and a strong presence in Asia (particularly China)

Theorem Clinical Research have the capability to manage even the most complex project – from study design to product launch and beyond.

Theorem Clinical Research are “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization.

Theorem’s comprehensive clinical service offering includes the following:

•               Project Management
•               Clinical Monitoring*
•               Clinical Data Management*
•               Regulatory Affairs*
•               Clinical Quality Assurance
•               Safety Surveillance/Pharmacovigilance*
•               Biometrics*
•               Clinical Writing
•               Investigator Agreements
•               Medical Affairs
•               Patient Recruitment

Mission

To improve patient lives through rapid acceleration of breakthrough disease management projects.

Vision

To manage our clients’ clinical trial projects faster and more effectively than our competition through:

•              Dedicated business units led by a team of operational experts and executive oversight
•              Global, specialized and experienced project teams comprised of well-trained clinical experts
•              Delivery of personalized and high quality customer service
•              Execution of localized site and patient recruitment strategies
•              Leveraging of our innovative processes and eClinical technologies

Theorem Clinical Research – History

Theorem Clinical Research may be new, but it is built on a long history of delivering exceptional services and support.

Prior to their launch in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company.

Theorem has grown into a global organization with 1,000+ employees in global office locations throughout 32 countries with a commitment to their clients and their success.

Key Milestones

2011: Omnicare Clinical Research is acquired by Nautic Partners, LLC, a strategic growth private equity firm. As part of the move, Omnicare Clinical Research became Theorem Clinical Research.

2010: Integrated operations with sister CRO Clinimetrics Research Associates, another wholly owned subsidiary of Omnicare, Inc. This integrative approach has led to an increased therapeutic reach, exchange of expertise and expanded global resources, coupled with specialization into focused business units designed to meet the specific needs of clients.

2009: Launch of Cardiovascular, Oncology and Vaccines Therapeutic Advisory Teams to provide projects with additional support from a medical, operational, regulatory and cost-effective perspective.

2008: Client Placement Service, bringing Omnicare Clinical Research clinical professionals on-site to client locations for extended assignments, formalized under the OmniTEAM® —Tactical Expertise And More—brand name.

2007: Launch of OmnieView University, our state-of-the-art eLearning Management System that provides targeted, on-line training to internal and external project members.

2006: Launch of empowered brand positioning and new tagline: People Who Really Care. In a Company Where it Really Matters(tm).

2005: Celebration of Omnicare Clinical Research 20th Anniversary

2004: Omnicare, Inc. acquires sister company Clinimetrics and strengthens medical device trial capabilities.

2003: Omnicare Clinical Research’s PAGeR Business Unit is established to provide dedicated resources for conducting peri-approval (Phase IIIB and IV) trials and clinical research projects in seniors.

2002: Opened offices in Bangalore, India and Tokyo, Japan to further penetrate Asia Pacific Region.

2000: Omnicare Clinical Research established.

Business Units

Theorem Clinical Research are structured into six distinct business units in order to optimize client satisfaction:

•               Early Phase
•              Phase II/III
•              Late Phase
•              Medical Device
•              Pharmaceutics
•              Technical Services

Early Phase

Theorem Clinical Research’s Early Phase Business Unit (Phase I/IIa) has a dedicated, streamlined approach that helps ensure they complete your study on schedule and on budget. Their goal is to exceed client expectations, each and every time.

Early Phase Study Type Expertise:

•               Single Ascending Dose (SAD)
•               Experimental Medicine
•               Drug-Drug Interaction
•               Pharmacokinetics (PK)
•               Dosing Finding/Ranging
•               Food Effect
•               Thorough QT Studies (TQTS)
•               Multiple Ascending Dose (MAD)
•               Proof of Concept
•               Bioavailability/Bioequivalence (BA/BE)
•               Pharmcodynamics (PD)
•               Bridging Studies
•               First in Man (FIM)

Early Phase Therapeutic Expertise:

•              Cardiovascular
•              Hepatology
•              Musculoskeletal
•              Obstetrics/Gynecology
•              Ophthalmology
•              Respiratory/Pulmonary
•              Vaccines
•              Endocrine
•              Nephrology
•              Neurology
•              Oncology
•              Psychiatry
•              Virology

Phase II/III Clinical Trials

As a mid-sized CRO, Theorem Clinical Research are the “right size” outsourcing partner. Small enough to provide clients with a personal touch and ability to maintain their focus on their clients, with a global reach across 32 countries, in all the key drug development markets, big enough to conduct large and complex global trials.

Theorem Clinical Research are able to assist their clients taking advantage of:

•              Strong Therapeutic Experience History
•              Global/Program Efficiencies
•              Project Acceleration
•              Site Management And Patient RecruitmenT (SMART) Team
•              Proven Governance Model
•              Highly Qualified and Experienced PDs
•              Global Footprint

Late Phase Clinical Trials

Late Phase (Phase IIIb/IV) trials are more important than ever. Whether it’s a proactive investigation into health outcomes, a safety surveillance study, Risk Evaluation and Mitigation Strategies (REMS), or leveraging a competitive advantage with a label extension, Late Phase research is a valuable commercial investment. Theorem’s  team of experts help to create a customized Late Phase study designed to achieve your particular goals and objectives.

Medical Devices

Whether you’re investigating an apparatus, instrument, machine or other type of device, Theorem’s Medical Device Business Unit appreciates success hinges upon highly specialized regulatory, reimbursement programs, safety and marketing support. Operating on high-quality systems, Theorem can prepare those key documents that will ultimately clear your product for marketplace entry.

Even after your commercial launch, Theorem will help propel your device to that next level, from developing a reimbursement strategy to meeting post-marketing surveillance requirements.

Technical Services

Theorem Clinical Services have a complete suite of Superior Solutions, Clinical Data Management, Biometrics and Medical Writing—all Wrapped with eTechnologies.

 Pharmaceutics

Clinical Supplies Packaging, Labelling, Storage and Distribution Services to Streamline Your Clinical Trial.

For nearly two decades, Theorem have been designing and implementing packaging to simplify even the most complicated dosage regimens. Their global presence provides cost-effective, timely delivery of any study medications and medical devices anywhere around the globe.

Clinical supplies packaging

Clinical supplies labelling

Clinical supplies storage

Clinical supplies distribution

For further information, please see:   http://www.theoremclinical.com/

Job Description

 Primary Purpose of the Job

Reporting the VP Business Development, International you will be responsible for the identification, negotiation and securing of new client relationships within your region and portfolio of companies.  You will also serve as overall Account relationship manager and strategic business partner for established account(s), in liaison with senior and operational Management.

You will be responsible for developing and expanding new business opportunities within allocated account(s) to include developing and overseeing the sales strategy for assigned clients, managing the sales process and coordinating with Project Management to ensure client satisfaction.  The focus will be on a given territory but with the scope of work to incorporate other European markets and to work as a key member of the business development team.

Having recently evolved to become Theorem Clinical Research, the company is looking to develop a unified global business development structure and approach. Theorem Clinical Research are looking to further enhance the calibre of the business development team through the hire of experienced, focused and exceptional Senior Account Directors and Account Directors who will lead, manage, motivate and mentor BD teams.

We are seeking individuals with strong networks and expertise, coupled to an impressive track record of success within one or more of the following areas:

•               Blue chip pharmaceutical clients
•              Emerging and developing medium and small pharmaceutical clients
•              Biotechnology clients
•              Geographical expertise within the UK / Benelux / Scandinavia regions
•              Geographical expertise within the German / Swiss / Southern Europe regions

Reporting to the Vice President Business Development, International, the Senior Account Director will be responsible for the identification, procurement and client management for allocated business in Europe. As well as being responsible for nurturing relationships with and securing business from allocated customer accounts, you will proactively identify and qualify new potential clients, develop relationships with decision makers and stakeholders and obtain business from them. This will involve:

•              Managing the complete sales cycle from cold calling to negotiating and closing the sale
•              Acting as point of contact to the client
•              Responding to client requests
•              Assisting in the preparation and review of proposal (including FTE and financial estimates)
•              Negotiating budgets, contracts, and assisting in the negotiation of ‘out of scopes’ as appropriate.

You will be expected to develop a comprehensive understanding of Theorem Clinical Research’s full portfolio of products and services arming you with the means to cross-sell and react appropriately to client needs.

Additional to this you will play a key role in the management and development of a business development / account management team in your region(s) and disciplines.  This will involve:

•              Ownership and management of a team target.
•              Responsibility for the training, development, mentorship and direction of the team.
•              Line management for more junior team members.
•              Assigning clients and accounts as appropriate.
•              Input into the European / Global BD approach and strategy.
•              Ability to drive sales, profitability and at all times maintain and develop the Theorem Clinical Research brand and culture.

Key Accountabilities:

•              Actively prospect and leverage potential new business opportunities within specified clients.
•              Cultivate strong, long-term relationships with key decision-makers within accounts and develops deep knowledge of the account organisations.
•              Identify and analyse potential opportunities and develop detailed business plans and sales strategies for each customer in liaison with CRU Management. Monitor actions and results against plans.
•              Identify and respond to client needs in order to define potential Theorem Clinical Research opportunities.  Ensure appropriate strategy and solution is proposed to the client.
•              Work with Project Directors and Function Managers to identify most appropriate sales team and prepare presentation. Educate team participants in client culture, operational needs, methods and sales techniques required to close the sale.
•              Lead the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation.
•              Coordinate with the Proposal Development Group (PDG) to develop proposal and CRU Management to finalise strategy and pricing.
•              Handle any follow-ups related to the sales and facilitates completion of contractual documents.
•              Ensure appropriate hand-off to project team by transferring knowledge regarding client needs and expectations.
•              Share account strategies and sales plans with Project Directors and Project Managers.
•              Coordinate with Project Managers, Project Directors and CRU Management to escalate and quickly address client issues and concerns.
•              Seek input from Project Managers and Project Directors as required to proactively address Changes In Scope (CIS), new opportunities or customer dissatisfaction.
•              Work with Project Managers, Project Directors and CRU Management to ensure CIS’s are appropriately negotiated with the client.
•              Maintain high visibility within client organisations.
•              Monitor client satisfaction through regular formal and informal surveys.
•              Coordinate with Project Managers and Project Directors to ensure the needs of the client are being met and address any concerns and issues in a timely manner.

 Person Specification

•              Advanced degree in business or scientific discipline is preferred but not mandatory.
•              Relevant scientific / medical / commercial qualifications.
•              Former experience in life sciences: Pharma, biotech, device, or consulting. Clinical Research experience is critical, ideally from an operational and business development perspective.
•              Demonstrable competency in sales or business development preferably for a Contract Research Organisation or company providing Phase II/III services to the healthcare industry.
•              An established network within the “region” pharmaceutical and biotechnology marketplace would be desirable.
•              Fluent written and spoken English and local market language skills.
•              A solid understanding of the clinical process (Phase II – III) coupled with a desire to develop existing knowledge.
•              Proven track record of successful business development and strong negotiation skills required.
•              Broad commercial experience and exposure to developing and closing significant deals and major accounts.
•              Solid understanding of the CRO sector and drug development.
•              Desire to build a career in sales and sales management.
•              Relish the challenge of identifying and building new relationships, internally and externally.
•              Credibility in both a Clinical and Commercial environment.
•              Strategic business awareness and results orientation. 
•              A record of demonstrable personal achievement.
•              Team player with outstanding inter-personal skills, negotiation skills and organisational skills.
•              Ability to work closely both with commercial and operational teams to ensure increased revenue, profitability and quality of deliverables to clients.
•              Knowledge of FDA regulated drug development process helpful.   
•              High-level skills in Microsoft PowerPoint.

Personal Characteristics

•              Self-motivated with a desire for success.
•              “Hands on” and “can do attitude”.
•              Outstanding interpersonal skills, personal selling skills and ability to “think on your feet”.
•              Excellent stakeholder/relationship management. Comfortable with internal and external client relationships.
•              Comfortable with managing and being managed against financial targets.
•              Clear ability to lead, manage, mentor and motivate others.
•              Highly credible in both a Clinical and Commercial environment.
•              Experience of working within dynamic and growing environments.
•              The ability to think both analytically and creatively and to use your initiative.
•              Desire and ability to build and sell the business.
•              Open and transparent working style.
•              Excellent prioritisation and organisation skills.
•              Highly results focused.
•              International and cultural awareness.
•              Consultative and flexible approach.
•              Approachable, personable and supportive of others.
•              Team player capable of working independently and with others.
•              Ability to juggle a complex and heavy workload and prioritise as appropriate.
•              Strong decision making ability with the “courage of your convictions”.
•              Thrives under pressure while maintaining a high level of personal and professional integrity.
•              Clear desire and ambition for success, comfortable making decisions and prepared to make the personal commitment to ensure success.

 Competencies

•              Strong detail orientation and an ability to work creatively in a fast-paced environment.
•              Excellent planning/organisational skills and ability to prioritise and multitask.
•              Results orientated.
•              Ensure written communications are accurate and consistent. Consistently follows up on issues in a timely manner.
•              Listen carefully and ask questions when necessary to ensure understanding.
•              Conveys information in a clear, concise, and accurate manner.
•              Display an open and flexible attitude, with a desire to support others and genuinely operate within a team structure and a team player.
•              Seek input from others when faced with a difficult situation.  Make sound decisions within the scope of responsibility.  Focus on resolving problems.
•              Demonstrate leadership skills.  Maintain positive relationships with clients and colleagues.
•              Demonstrate honesty and integrity in dealing with others. Works effectively with different types of people.
•              Portrays sound knowledge of clinical research and clinical development processes.
•              Demonstrates professionalism and presents a positive image of Theorem Clinical Research.  Listens to and then demonstrates an understanding the customer’s needs before presenting a solution.
•              Ability to effectively handle difficult and complex customer situations.  Maintains a high energy level when interacting with customers to find a creative solution.
•              Willingness to learn and build upon your existing knowledge of drug development.
•              Clear and presentable understanding of the long terms needs within clinical research as well as the customers’ immediate and short term resource requirements.
•              Maintains positive relationships with clients and colleagues.  Demonstrates honesty and integrity in dealing with others.  Works effectively with different types of people.  Accepts and applies constructive feedback.
•              Seeks input from others when appropriate.  Makes sound decisions within the scope of responsibility.  Focuses on resolving problems.
•              Demonstrates commitment, dedication, cooperation, positive behaviour, adaptability and flexibility with changes in responsibilities and duties.

Package

•              Base salary commensurate with experience
•               Life Assurance of 4 x base salary
•               Long Term Disability Insurance – up to 2 years of salary
•               Private Medical insurance for employee and family, company funded
•               Membership of Group Personal Pension Scheme – Company contribution to match employee contribution at 2.5% or 5% contribution
•               Car Allowance £510.00 per month
•               Company funded fuel for business and private mileage within the UK
•               Holiday 25 days per annum
•               Hours 9.00 to 5.30 i.e. 7.5 hours per day 37.5 hour week
•               Additional flexible benefits

PRA International is one of the world’s leading Global Clinical Research Organisations.

With an established presence, spanning more that 30 years, they have enjoyed continual growth and success, currently employing 3,200 staff  globally.

PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge.  This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers.

PRA International – History

• Established in the late 1970’s with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA.
• In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location.
• 1996 saw the company name change to PRA International as the company moved towards becoming a global CRO with 333 employees.
• In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International’s clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory.  Additionally they gained a Phase I facility.
• In 1999, PRA acquired Valorum (UK) Ltd, based in Reading, UK. This acquisition enhanced their regulatory expertise and expanded PRA’s trial management footprint in Europe.
• In 2000, PRA acquired ARCAM, an international CRO based in Paris, France.  This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance.  This enhanced PRAs European footprint to in excess of 250 employees.
• In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management.
• In 2002, PRA acquired CroMedica, a CRO headquartered in Canada with key expertise in the CNS therapeutic area and global operations. Several of their offices now represent PRA in Victoria, British Columbia; San Diego, California; Sao Paulo, Brazil; Johannesburg and Cape Town, South Africa; and Sydney, Australia.
• In November 2004, PRA became a publicly traded company on the NASDAQ exchange.
• In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services.
• In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany.  Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA’s Early Development Services plan to further strengthen its position as an industry leader.
• PRA returned to being a privately held company when it was reacquired by Genstar Capital, LLC in December 2007. Genstar had been PRA’s largest investor before the initial public offering in 2004.

PRA International’s mission: ‘Our people commit to provide innovative solutions that our clients rely upon to introduce new drugs and to improve lives’

PRA International – Core Values

• Unquestionable ethics and integrity
• Consistent and measurable quality in all they do
• Outstanding service and flexibility to meet customer requirements
• Commitment to staff development and collaboration
• Demonstrated technical and therapeutic excellence throughout the company

PRA International – Key Services

Trials Management Services

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification
• Investigator handbook and meetings
• Investigator site management
• Investigator site monitoring
• Medical monitoring and drug safety
• Data management
• Analysis and reporting
• Medical and scientific publications
• Regulatory filings

Early Development Services

• First in man studies
• Single and multiple dose safety and tolerability studies
• Food effect
• Proof of concept studies
• Interaction studies with drugs and food
• Mass balance / ADME studies
• Micro dosing studies
• Single and multiple dose bioavailability studies
• QTc – prolongation and intensive ECG studies
• PK studies in renally impaired patients
• PK studies in hepatically impaired patients
• Special population studies
• Special formulations
• Vaccine studies
• Studies with biotechnology-derived therapeutic products

Late Phase Services

• Safety surveillance
• Post-authorisation safety studies (PASS)
• Restricted access programs
• Retrospective studies

Drug Safety Management

• Reporting of serious adverse events
• Processing and reporting of adverse drug reactions (ADRs)
• Periodic safety update reports
• Safety and Pharmaco-Epidemiological Studies
• Global database pooling and integrated summaries of safety
• Consulting and system analysis

Electronic Regulatory Submissions

• Protocol and Case Report Form design
• Feasibility study
• Project Management
• Investigator site selection and qualification

For further information, please go to www.prainternational.com

Primary Purpose of the Role

Responsible for clinical operations activities and staff within the unit(s). Mentors and leads the clinical operations management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices. Provides leadership in the implementation of PRA’s quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy. Provides strategic direction to the Clinical Operations department.

Accountabilities (Responsibilities)

• Sets overall direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
• Mentors and develops employees to expand employee performance levels and assure retention of high performing PRA employees
• Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
• Establishes processes and participates in PRA’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
• Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
• Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic specific nuances while identifying potential impacts of the same to budget
• Participates in client presentations and/ or bid defense meetings, as required
• May function as legal representative for PRA in selected countries as appropriate
• Broader focus on moderate to complex projects. Less supervision by VP or Exec Director
• Strategic focus for all projects independent of degree of complexity. Works under general guidance by VP, but minimum oversight required

Package

• Competitive basic salary
• Bonus  Company Car or Car Allowance
• 5% non-contributory pension
• Private healthcare
• Life Assurance (4 X base salary)
• 25 days’ holiday

Committed to Improving the Lives of Patients Worldwide

Celgene Corporation, a uniquely positioned entrepreneurial biopharmaceutical company,   and its employees are working relentlessly to provide novel solutions for unmet medical needs in cancer and debilitating inflammatory diseases.

Celgene’s goal is to provide next-generation innovative therapies that deliver quality outcomes for better healthcare.

Celgene is dedicated to improving healthcare by delivering more disease-altering therapies to patients in need. In order to achieve this, there are more than 200 ongoing clinical trials at major medical centres worldwide using innovative compounds from Celgene. These promising drugs include many high-potential compounds in their rich and diverse regulatory pipeline. These investigational compounds may address immediate medical needs of patients with incurable haematological and solid tumour cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukaemia (CLL), non-Hodgkin’s lymphoma, glioblastoma, ovarian, pancreatic and prostate cancer.

Celgene is committed to improving the lives of patients worldwide. By utilising the latest advances in molecular and cellular research to develop novel therapies that target the mechanisms of disease at their source, Celgene is making potentially life-saving treatments a reality for the millions of patients around the world fighting cancer and other debilitating diseases.

Celgene has built a discovery, development, and commercialisation platform for drug and cell-based therapies that allows them to both create and retain significant value within their therapeutic areas of cancer and inflammatory diseases. This target-to-therapeutic platform approach integrates both small molecule and cell-based therapies and spans the key functions required to generate a broad, deep and diverse pipeline of new drugs and cell therapy candidates, including:

• cell biology, genomics, proteomics and informatics technologies for identifying and validating clinically important therapeutic targets;
• high throughput screening systems combined with diverse and focused compound libraries for discovering new drug leads;
• computational and medicinal chemistry for optimizing drug candidates;
• in vitro and in vivo models of disease for preclinical evaluation of drug efficacy and safety;
• a clinical and regulatory organisation highly experienced in the successful development of pharmaceutical agents.

The ongoing development of immunomodulatory agents, cell-signalling inhibitors, as well as cellular and tissue therapeutics may allow Celgene to provide physicians/clinicians with a more comprehensive and integrated set of therapeutic solutions for managing complex human diseases such as cancer and inflammatory-related diseases.

Celgene History

• Celgene was initially founded as a unit of the Celanese Corporation in 1980. However, following the 1986 merger of Celanese Corporation with American Hoechst Corporation, Celgene was spun off as an independent biopharmaceutical company.
• In July 1998, the company received approval from the FDA to market THALOMID® (thalidomide) for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of
• ENL recurrence. In May 2006, Celgene received approval for THALOMID in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.
• Over 145,000 patients have been prescribed the innovative product, THALOMID (thalidomide), through Celgene’s patented S.T.E.P.S. ® (System for Thalidomide Education and Prescribing Safety) delivery program. Designed in collaboration with the FDA for the restricted distribution of THALOMID, S.T.E.P.S. involves four of the 830 pending and issued patents in our expanding intellectual property estate.
• In April 2000 an agreement was reached with Novartis Pharma AG to license d-MPH our chirally pure version of RITALIN®. The FDA subsequently granted approval to market d-MPH or FOCALIN® in November 2001.
• With products on the market, Celgene completed a merger with Signal Pharmaceuticals, Inc., a privately held biopharmaceutical company focusing on the discovery and development of drugs that regulate genes associated with disease.
• On December 31, 2002, Celgene acquired Anthrogenesis Corporation, a privately held New Jersey based biotherapeutics company and cord blood banking business, which has also pioneered the recovery of stem cells from human placental tissue following the completion of a full-term, successful pregnancy.
• In December 2005, Celgene received approval from the FDA to market REVLIMID® (lenalidomide) for the treatment of patients with transfusion-dependent anaemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
• In June 2006, the FDA approved REVLIMID in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. REVLIMID is only available through a restricted distribution program called RevAssist®. EMEA approval for the REVLIMID® multiple myeloma indication (in combination with dexamethasone) was received in June, 2007.
• In March 2008, Celgene announced it had closed its $2.9 billion acquisition of Pharmion Corporation. The transaction brings together three medically meaningful therapies, REVLIMID®, THALOMID® and VIDAZA®, treating patients worldwide. These products are expected to generate multiple global revenue streams for accelerated financial growth as Celgene move into nearly 100 countries over the next five years and beyond.
• In January 2010, Celgene announced the acquisition of Gloucester Pharmaceuticals. The transaction brings to Celgene ISTODAX® (romidepsin), an approved therapy for the treatment of cutaneous T-cell lymphoma (CTCL), providing a strategic fit and expanding the company’s presence in critical blood cancers.
• 2010 saw the approval of REVLIMID for multiple myeloma and deletion-5q MDS in Japan.
• In October 2010, Celgene announced the acquisition of Abraxis BioScience for $2.9 billion cash and stock to further enhance their expertise and position as a global leader in Oncology.  This will further bolster their solid tumour pipeline with the acquisition of ABRAXANE, used in the treatment of metastatic breast cancer.

Driving the commercial success and profitability of the company are marketed products, which include THALOMID® (thalidomide), REVLIMID® (lenalidomide), VIDAZA® (azacitidine) and ISTODAX®. Celgene also receives royalties from Novartis Pharma AG on sales of the entire RITALIN family of drugs, which are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD). The company’s strong, growing revenue base will provide the financial strength to propel the successful development of new products for multiple indications that Celgene is committed to introduce over the next several years.

Celgene invests over 30% of its total revenue in the R&D that is essential to its future success. This significant investment clearly demonstrates its commitment to successfully expand the company’s profitable commercial franchises, advance its development pipeline, and discover new classes of compounds with meaningful medical benefit.  The company’s broad, deep and proprietary pipeline of seventeen product development programs spans all phases from preclinical to Phase IV.
Celgene is now an integrated biopharmaceutical company focused on discovering developing and commercialising innovative therapies to treat cancer and inflammation through gene and protein regulation.

Celgene’s Commitment:At Celgene, we believe that a commitment to medical progress achieved through innovative science and life-enhancing new therapies must go hand in hand with a corresponding promise to ensure that patients who can benefit from our discoveries have the opportunity to do so.     www.celgene.com

CITRE®, the Celgene Institute for Translational Research Europe  is providing Celgene with the platform to build an International presence in Seville, Spain.

This is a significant investment by Celgene in the continued development of cutting edge technology in Europe.  It will represent Celgene’s first centre outside of United States exclusively dedicated to R&D.

The centre will grow over the next three years to 30 international scientists intent on bridging the gap between basic science and clinical research, combining the talent and expertise from within the Biopharmaceutical industry and academia.

The Celgene Institute of Translational Research Europe, occupies more than 1000 square meters divided into three floors within a building at the Cartuja93 Science and Technology Park in Seville – http://pctcartuja.es/Home/tabid/77/language/en-GB/Default.aspx

CITRE will be the focal point for advanced biomedical research including regenerative medicine, personalized medicine and cellular therapies.

CITRE will consist of five departments:-

• Tumour bio banking,
• Bioinformatics,
• Placental stem cells,
• Epigenetics
• Cell signalling

These functional departments will be further supported by five services:-

• Cell culture
• Cytometry
• Electronic microscopy
• Genomics
• Proteomics

Located in Seville, Spain, CITRE reflects a shared vision between Celgene and the public sectors of Spain and Europe to provide a bridge between the discoveries of basic research and their application in addressing the needs of modern medicine.

Celgene invested approximately $800 million in research, traditionally investing about 30% of the company revenues in R&D.

Prerequisites

• Experience in the drug development process from preclinical research through clinical development in an industry setting
• Strong analytical and computational skills
• Experience in statistical laboratory testing methodologies
• Understanding of clinical databases
• A background in Oncology, Translational Research, Pathway Analysis, Quantitative Methods for Systems Biology, Network Analysis, or Simulation are a plus
• PhD
• Responsibilities include, but are not limited to:
• Conduct predictive biomarker data analysis based on cancer cell lines and primary tissue
• Provide critical input on clinical biomarkers and patient stratification for late stage compounds based on statistical analysis results
• Supervise bioinformatics personnel at the Sevilla site

Personal Qualities:

• Champions change
• Leads courageously
• Networking
• Provides direction
• Structuring and staffing
• Thinks strategically

Skills/Knowledge Required:

• PhD in computational or life sciences (biologist or chemist with computational sciences training  and experience or computational scientist with educational background in biology and chemistry)
• At least 5 years of relevant biotechnology or pharmaceutical industry experience
• Working knowledge of genomic technologies
• Expertise in the development of algorithms to analyze and interpret complex datasets particularly those associated with pharmacogenomics, pharmacogenetics and biomarker discovery
• Thorough understanding of statistical principles and their appropriate implementation
• Outstanding communication skills
• Customer-driven with the ability to collaborate across multiple Research functions and geographic sites
• Fluent in at least one of following statistical software programs: R, SAS, Matlab, or HPSS

Package

• An attractive salary and benefits package will be offered, commensurate with experience, for the right candidates
• Relocation costs, where appropriate
• The package is negotiable, based upon the level of experience of the individual.

Prerequisites

      Experience in the drug development process from preclinical research through clinical development in an industry setting

      Strong analytical and computational skills

      Experience in statistical laboratory testing methodologies

      Understanding of clinical databases

      A background in Oncology, Translational Research, Pathway Analysis, Quantitative Methods for Systems Biology, Network Analysis, or Simulation are a plus

      PhD

Responsibilities include, but are not limited to:

      Conduct predictive biomarker data analysis based on cancer cell lines and primary tissue

      Provide critical input on clinical biomarkers and patient stratification for late stage compounds based on statistical analysis results

      Supervise bioinformatics personnel at the Sevilla site

Personal Qualities:

      Champions change

      Leads courageously

      Networking

      Provides direction

      Structuring and staffing

      Thinks strategically

Skills/Knowledge Required:

      PhD in computational or life sciences (biologist or chemist with computational sciences training  and experience or computational scientist with educational background in biology and chemistry)

      At least 5 years of relevant biotechnology or pharmaceutical industry experience

      Working knowledge of genomic technologies

      Expertise in the development of algorithms to analyze and interpret complex datasets particularly those associated with pharmacogenomics, pharmacogenetics and biomarker discovery

      Thorough understanding of statistical principles and their appropriate implementation

      Outstanding communication skills

      Customer-driven with the ability to collaborate across multiple Research functions and geographic sites

      Fluent in at least one of following statistical software programs: R, SAS, Matlab, or HPSS

Package

   An attractive salary and benefits package will be offered, commensurate with experience, for the right candidates

   Relocation costs, where appropriate

   The package is negotiable, based upon the level of experience of the individual.