Role Summary
The Senior Medical Director, US Medical Affairs executes Medical Affairs programs and deliverables through partnership with Medical Science Liaisons, Scientific Communications, Publications, Health Economics and Outcomes Research (HEOR), Clinical Development, and the Commercial Team. The role is accountable for high quality execution of Medical Affairs activities and supports relationships with external experts, in conjunction with the Medical Science Liaison team.
Responsibilities
- Provide support for planning and execution of the ruxolitinib Medical Affairs program strategy.
- Expertly deliver scientific and medical information and interpretation of clinical research findings.
- Provide medical and scientific expertise in a cross-functional environment to field based medical science liaisons as well as internal stakeholders (Medical Affairs functions, Marketing Department, Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, and Drug Safety/ Pharmacovigilance Department, Sales Training).
- Participate in the design, conduct, analysis, and reporting of Medical Affairs led clinical trial and observational studies.
- Provide scientific review and expertise for independent investigator-sponsored trials (ISTs).
- Support lifecycle management activities for ruxolitinib.
- Plan and execute medical advisory boards.
- Provide Medical expertise to the Commercial organization, including review of promotional materials, sales training, and speaker training for promotional programs.
- Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings.
- Maintain high level of expertise in oncology / hematology and serve as key medical resource for the oncology therapeutic area and on specific products.
- Provision of medical/scientific expertise for relevant marketing materials (including all promotional material) copy review in the Medical-Legal-Regulatory (MLR) Committee.
- Interact with the Medical Affairs function at Novartis, our partner for activities outside of the U.S.
- Develop, track, execute and report on goals and objectives.
- Be accountable for compliant business practices.
Qualifications
- Required: M.D. degree or equivalent.
- Required: ABIM Board Certified or Board Eligible status in Hematology, Medical Oncology or Internal Medicine (equivalent foreign certification accepted).
- Preferred: Pharmaceutical industry work experience of 5+ years.
- Required: Experience as either Medical Monitor for Industry-sponsored studies or (principal or associate) Clinical Investigator in academia.
- Preferred: Medical Affairs, Understanding of Clinical Development and Commercial activities.
- Required: Ability to partner effectively with Field Medical staff.
- Preferred: Solid understanding of Health Economics and Payer environment.
- Required: Strong clinical insight, understanding of translational medicine and knowledge of clinical trials, including registries, and successful prior experience in the management of an IST portfolio.
- Required: Strong business acumen, vision and perspective.
- Required: Ability to comprehend and combine complex sets of data.
- Required: Ability to educate internal stakeholders on disease state and/or product/ brand-specific information.
- Required: Ability to present and discuss complex clinical, medical, biological, or translational data.