US Senior Medical Director, Medical Affairs Teriflunomide MS
In a matrix environment, the Senior Medical Director for US Medical Affairs will perform a key role in the clinical and commercial development of Teriflunomide in MS, through strategic alignment and execution of activities related to investigator and expert outreach, investigator sponsored trials, company sponsored non-registration trials, publication planning, CME, grants, sponsorships. As part of the execution of Genzyme strategy, he/she will work closely with the leadership of Genzyme's US Medical Affairs, Clinical Research, Commercial and Product Management functions. This position will report to the Senior Director of Medical Affairs, Teriflunomide MS.
Support the US initiative for MS thought leader relationship-building. The Medical Director is responsible for cultivating current and future MS experts in academic and clinical medicine at regional and national levels. Through these relationships, the Senior Director will gain meaningful expert insights that influence priority areas of the product Life Cycle Planning team in support of business, clinical and scientific strategy.
Liaise regularly with internal business leaders to share feedback and issues from MS experts.
Support the development of Investigator Sponsored studies. Through MS expert relationships, the Senior Medical Director will facilitate the initiation of research projects and ensure that hypothesis testing is clearly defined and within priority areas consistent with the strategic development objectives of Teriflunomide in MS. He/she will be responsible for the successful execution of appropriate processes for review, approval, management and support of studies while maintaining investigator independence according to regulatory and compliance guidelines.
Strategic and substantive input to publication planning and execution to ensure that all data on Teriflunomide in MS generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner.
Provide Medical Affairs support to the review of requests for grants and sponsorships.
Ensure that review and approval processes strictly follow compliance guidelines.
In anticipation of product launch, the Senior Medical Director will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams. Provide medical support to promotional and legal review committees as needed.
Represent Genzyme at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders.
Maintain knowledge of MS market place, stay current on leading edge products development efforts and provide perspective to the business on the treatment landscape.
Define and develop needs analyses for MS Medical Science Liaison (MSL) functions in the US to ensure that those carrying out the MSL function are optimally educated to be experts on MS, Teriflunomide development, and the competitive landscape.
Provide ongoing support for company sponsored trials in alignment with Clinical
Development strategy. Ensure that conduct is in keeping with regulatory guidelines.
The Senior Medical Director will ultimately, via opinion leader network relationships, facilitate the initiation of research projects within priority areas as determined by the product Life Cycle in support of business, clinical and scientific strategy.
Neurology board certified/eligible
Expertise in Multiple Sclerosis
M.D. board certified/eligible
At least ten years of experience in the biotech or pharmaceutical industry in Medical Affairs, with experience working with cross-functional in-house and field-based teams
Experience in both clinical development and patient care
Excellent interpersonal skills
Ability to work with and effectively support cross-functional teams
Proficiency in public speaking
The title and position will be based on experience and qualifications.
State or Province