Director, Global Medical Affairs - Pompe
Director, Global Medical Affairs - Pompe
Sanofi
Amsterdam, Netherlands
The Director, Global Medical Affairs (GMA) - Pompe will report to the Head of Medical Rare Neuro-Metabolic and will be part of the Global Medical Affairs Rare Disease Team.
The Director, GMA - Pompe will lead Medical activities in the Pompe disease space and will be working closely with the Avaglucosidase launch team. This person will be expected to drive medical affairs activities including medical education, overseeing registry activities, epidemiological projects, diagnostic strategy and publications.
The position requires the ability to work effectively in a highly matrixed environment; highly team oriented with outstanding interpersonal skills and ability to collaborate effectively with other groups will be needed, as will a demonstrated ability to see the big picture while not losing focus on project specifics; the ability to both develop project strategies and execute project details.
A strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards is required.
In the day to day business the Driector, GMA - Pompe will build strategic plans, supervise the implementation and execution of the medical affairs activities across broad range of countries in US, Europe, and JPAC and interface with Emerging Markets. They will manage indirect reports and build external partnership with health care partners and scientific organizations.
In addition, they will work closely with the leadership of Sanofi Genzyme’s Research, Clinical Development, Commercial, Health Economics and Value and Access and Product Management functions in the US and worldwide to support optimal life cycle management in Pompe.
Job Responsibilities:
- Oversee management of strategy around Investigator Sponsored Studies and Phase IV Medical Affairs Studies, including chairing the Scientific Review Committee to ensure that the LCM strategy is clearly defined and consistent with the clinical development and strategic objectives for each product, and that appropriate processes are in place for review, approval, management and support of studies that are scientifically sound;
- Lead, along with colleagues in Global Scientific Communication, management of publication planning and execution to ensure that all data on Sanofi Genzyme products generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner;
- Lead activities to define the scientific platform for each product along with Global Scientific Communications colleagues;
- Oversee management of funding for CME, grants, and sponsorships to ensure that funds are allocated appropriately to activities consistent with the clinical development and commercial objectives of the business, and that review and approval processes are in place to maintain strict compliance with all federal regulations;
- Responsibility and accountability for the financial management and reporting requirements for medical affairs, including supporting the Finance reporting process with accurate and timely data and assumptions as needed to support budgeting, forecasting and long range planning for the business units. Manage the budget;
- Ensure that medical guidance is provided to marketing and sales teams;
- Participate in relevant Sanofi Genzyme Product Teams to provide expertise and ensure alignment of medical affairs with clinical development and commercial activities;
- Provide leadership in identifying needs for post-marketing clinical trials and registries and oversee their management and execution;
- Represent the function at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KOLs;
- Travels regularly (both internationally and within the US) as necessary.
Qualifications:
- M.D., PhD, PharmD (or MCG with 10 years experience) with significant pharma medical affairs experience preferred or equivalent industry experience;
- Significant leadership and management experience in Medical Affairs or other aspects of the life sciences sector;
- Demonstrated ability to work effectively in a matrixed environment;
- Proficient in public speaking;
- Five years of experience in the biotech or pharmaceutical industry.
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