Vice President Global Medical Affairs Rare Diseases-32453
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Vice President Global Medical Affairs Rare Diseases
The Vice President, Medical Affairs Rare Diseases will build and manage a medical affairs group dedicated to supporting products across the Rare Diseases therapeutic areas. The Vice President, Medical Affairs will play a key role in the clinical and commercial development of Genzyme's rare disease products through strategic guidance and oversight of activities related to investigator sponsored trials, company sponsored non-registration trials, publications, and Key Thought Leader (KTL) outreach. Based on the affiliate insights and in coordination with the cross functional global team the VP will develop the global medical strategies for Rare Diseases. In addition, the VP will work closely with the leadership of Genzyme's Clinical Research and Commercial functions in the regions worldwide to support optimal life cycle management for all products. The primary goal of this position is to maximize patient benefit from Genzyme rare disease products based on key thought leader insights for strategic plans, development of the relevant data evidence and publications and knowledge development via Medical Education to support health system access.
Contribution of Medical insights for business plans in order to gain access into health care systems.
Development of medical strategies to provide relevant data evidence from company and Investigator Sponsored Studies (ISS) to ensure that the 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 while maintaining investigator independence. Oversee management of publication planning and execution to ensure that all data on Genzyme rare disease products generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
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
Manage the regional medical officers in US, EU, LATAM and JAPAC. Provide guidance and strategic direction to Medical Affairs activities supporting rare diseases to the Genzyme affiliates worldwide.
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.
Lead KTL engagement and knowledge development.
Ensure that medical guidance is pro-actively provided to marketing and sales teams
Contribute strategic guidance to relevant cross functional Product Teams. Provide expertise and ensure alignment of medical affairs with clinical development and commercial strategies / tactics with the objective to gain access into health care systems
Provide leadership identifying needs for post-marketing clinical trials and registries and oversee their management and execution
Represent the Genzyme Rare Diseases business units at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KTLs
Represent Genzyme Rare Diseases business units at the corporate level and in interactions with other business units to optimize coordination and collaboration around areas of overlapping interests
Travels regularly (both internationally and within the US) as necessary
Board Certified M.D., preferably with experience in specialty medicines/ rare diseases
Extensive experience in medical affairs (10 + years) required
Management experience of a country affiliate medical team and a regional or global medical affairs team.
Experience in clinical development, health economics or commercial functions desired.
Well established leadership skills
Demonstrated ability to work effectively in a matrix environment
Excellent communication skills, condensed business language, very good presenter in front of internal and external audiences
Customer oriented strategic thinker. Excellence in implementation
Proficient in public speaking
Job : Medical Affairs
Primary Location : United States-Massachusetts-Cambridge
Job Posting : Feb 27, 2013
Shift : Day Job
Job Type : Regular
Employee Status : Regular
Genzyme - 9 months ago