Vice President Clinical Operations Europe

Vice President Clinical Operations Europe 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 Registries studies

Strategic Consulting

• Market Access
• Regulatory Affairs & Quality Management

Linguistic Validation

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

A separate entity, the MAPI RESEARCH TRUST is 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, 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 in:

• Pharmaco-epidemiological Studies
• 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.

Strategic Consulting

The strategic Consulting companies offer a wide range of services with recognised experts in each domain including market access, patient reported outcomes (PRO), pharmacoepidemiology, risk management, signal detection and regulatory affairs & quality management. It is comprised of six companies:

Mapi Values:

A global leader in developing, substantiating, and communicating evidence-based value to support the successful development of pharmaceutical products Led by Patrick Marquis a member of the European Regulatory Issues on Quality of Life Assessment (ERIQA), MAPI Values employs 90 staff in the UK, The Netherlands, France, the USA and Japan. MAPI Values offers a complete range of health economics and patient reported outcomes (PRO) services across all phases of pharmaceutical, biotechnology and medical device development and commercialisation in a joint venture with the Adelphi Group.

JNBD:

Founded in 1992 and acquired by MAPI in 2007, JNBD is a regulatory, market access and quality specialist for drugs, medical devices and diagnostic tests. Their services cover total product life and positioning, developing strategy and health care systems, including market access and regulatory and pharmaceutical affairs support.

MAPI Institute:

Is a world leader in the field of linguistic validation, providing multilingual translation using rigorous methodology developed from many years experience. In-house knowledge of 20 languages and a worldwide network comprising 230 consultants support the delivery of a number of key services including:

• Linguistic validation of PRO and CRO instruments: 500 instruments into 110 languages
• Translational Assessment
• Preparation of manuscripts
• Formatting and printing
• Mapi Research Trust:

Is a non-profit organisation serving the information needs of research scientists, biopharmaceutical companies and governmental health agencies, on a global basis. MRT specialises in providing reliable, comprehensive and up to date information services within Patient-Reported Outcomes and Pharmaco-Epidemiology.

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 have an established infrastructure which is needed to perform large, multinational observational studies and registries.
• They have more than two hundred specialist employees in ten locations and have conducted studies in over 32 countries.
• They have completed the acquisition of a U.S late phase company which will mean significantly increased resource and late phase expertise globally.
• 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 conduct and analysis of late phase studies which provides an excellent platform for further new business generation.
• 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:

• Working closely as a key member of the organisation's Executive Leadership Team and reporting to the CEO Europe, the Vice President Clinical Operations, Europe is responsible for operations in Europe and affiliated territories outside of North America.
• Responsibilities include the strategic development, implementation and oversight of international Operations to ensure growth, profitability, quality and customer service goals are achieved. The position also ensures appropriate standards, policies, systems and procedures are in place to drive the required levels of performance, continual improvement and compliance throughout operations.
• The VP European Operations works in partnership with other functional leadership at regional and global levels to support the worldwide harmonisation of operations consistent with the direction of a global, integrated CRO.
• The position provides management and direction for all planning and control of European Operations activities, including employment, promotion, performance management, training and counselling of Operations staff.

Primary Purpose of the Job

Leadership (General)

• Drives international project/operations strategy and oversight and participate as part of the senior management team in both short and long-term strategic planning for Operations.
• Provides regional management and operations staff with leadership, support and guidance on operational issues (internal and external).
• Fosters a supportive and inclusive working environment through individual leadership and effective teamwork.
• Drives local and international growth for the business and individuals within the business, creating shared best practices whilst recognising international differences.

Customer facing/Sales

• Interacts with senior client management to provide senior point of contact to promote relationship health and resolution of operational issues.
• Participates in sales and marketing activities including attendance at customer meetings to ensure Operations and the broader REGISTRAT MAPI business are represented and presented well.
• Provides input to, and review/approval of, bid proposals and contracts.

Operations Management

• Works with the CEO Europe and Finance staff, in preparing, implementing, and managing budgets and staffing for Clinical Operations.
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