Merck Director, Medical Affairs, Biosimilars in Montreal, Canada
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Director, Medical Affairs, Biosimilars
Location: Montreal, Quebec
Reporting to the Vice-President, Medical Affairs, the Director, Medical Affairs (“the Director”) is primarily responsible for setting the overall Medical Affairs strategic direction to the Biosimilars Medical Affairs Team.
Leading a group of Medical Adviser and MSLs, and working in concert with his/her commercial counterparts; the Director will provide expert strategic input in support of the objectives of the Therapeutic areas (TAs) of Rheumatology, Gastroenterology and Dermatology under her/his responsibility.
The Director holds the overall responsibility for the strategic development, execution and delivery of tactical objectives of Medical Affairs Plans for the TAs, in alignment with the overall strategic objectives in Canada. This will include tactical deliverables such as post-licensure studies, publication plans, and other knowledge transfer activities. The Director will work within a Canadian framework in alignment with the direction provided by the respective Global Teams and the Regional Director Medical Affairs EMEAC, identifying areas of strategic interest within the Canadian scope, and addressing those with a tactically focused Medical Affairs Plan for each TA under his/her responsibility.
The Director should have a customer-focused approach, developing professional relationships with scientific leaders in Canada and supporting efforts in key strategic areas. These interactions may also extend to regulatory bodies, payers groups and key advocacy groups.
Internally, the Director will have an active participation in key strategic teams to provide expert medical advice and technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities. The incumbent will share medical/scientific expertise with his/her counterparts in other functional areas such as Regulatory Affairs, R&D, Quality Assurance, Legal and Marketing in Canada, and throughout the EMEAC Region as requested. The position will also maintain responsibility for support towards new approvals and regulatory reporting as required.
Core responsibilities include:
Scientific leadership: Overall responsibility for the development, prioritization and delivery of the Medical Affairs Plans (MAP) that address identified gaps.
Interactions with Regional and Global Medical Affairs to advocate for support of Canadian initiatives at the regional/global level.
Interactions with Global Clinical Trials Organization (GCTO) and CORE (Center for Observational and Real-world Evidence) Organization in support of country portfolio of Phase II-III trials, Local Clinical Evaluations and Investigator-Initiated Studies, and to continue to attract clinical development studies to Canada.
Support to the corresponding Business Unit, Market Access and Policy and Government Affairs Group to ensure the successful management of existing products and launches of new products.
Role model high ethical and compliance standards to the associates within the TAs and contribute proactively to a credible image for Merck Medical Affairs to external and internal stakeholders.
Drive talent acquisition, retention and development for associates in the TAs.
Maintain cost control against budget targets for the responsible area.
Experienced Medical Pharmaceutical Leader, with extensive knowledge of the pharmaceutical industry and the drug development process.
Education: Minimum Pharm D, or Ph.D., with a strong preference for a M.D. degree.
Experience: minimum 10 year experience in global biopharmaceutical industry; minimum 5 years of relevant people management experience is required.
Must possess a comprehensive clinical knowledge in one of the above mentioned TAs, as well as a keen understanding of strategic clinical development and principles of study design.
Excellent written and verbal communication skills. Advanced negotiation, presentation and facilitation skills.
Strong ethics and integrity. Solid knowledge of GCP principles and of the Canadian IMC Code.
Strong people management and team leadership skills, as well as listening and coaching skills.
Ability to work in high performance teams, and in a matrix organization. Excellent team player; must excel at teamwork in cross-functional groups. Must be able to interact successfully with a variety of individuals at the local, regional and global level, which includes local clinical investigators, contract research organizations (CROs), payers, administrators, regulatory officials and individuals of various patient advocacy organizations with a particular interest in our products and clinical trial outcomes.
Language: Bilingual (French and English) preferred but not required.
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Job Medical Affairs Generic
Title: Director, Medical Affairs, Biosimilars
Primary Location: NA-CA-QC-Montreal (Kirkland)
Requisition ID: MED004131