Responsible for creating and leading a high performing Medical Affairs function.
Reporting Relationship: Vice President, Drug Safety & Pharmacovigilance
- Create the Medical Affairs function, capabilities, culture and practices appropriate in size and scope for innovative R&D company focusing on new drugs in oncology with a first-in-class product and first-for-the-company launch.
- Provide strategic leadership for Medical Science Liaisons, publications, Medical Information, educational and research grants, investigator-initiated trials, medical document review, and medical support for commercial strategy.
- Identify, hire, train, and manage high performing talent.
- Establish Health Economics Outcomes Research (HEOR) function to create materials to support payer/reimbursement activities.
- Work with Medical Science Liaisons to broaden Boston Biomedical’s KOL base.
- Develop and implement patient advocacy roadmap as appropriate for portfolio compounds.
- Establish Medical Information call center and processes to respond to information requests, connect adverse events reports to Pharmacovigilance, and prepare medical letters on clinical data.
- Facilitate activities to support investigator-initiated trials and problem solve at investigator sites.
- Develop and manage process for continuing medical education grants.
- In collaboration with R&D and Commercial, plan for and develop non-registrational trials, secondary data analyses, and prepare timely and scientifically accurate publications.
- Serve as point person for major conferences, strategically targeting relevant meetings to advance key objectives. Also ensure appropriate staffing at major medical conferences.
- Create effective scientific and medical presentations/materials that can be directly applied to support launch plans and enable strong prescriber and patient acceptance.
- Provide disease and product training to the Commercial organization, including creation and effective adoption of launch training material.
- Establish and promote productive working partnerships with parent and cross-functional resources as appropriate.
- Perform other duties and responsibilities as directed and required.
- M.D with 10-12 years of experience in Medical Affairs or combination of academic and industry experience in the oncology Medical Affairs field.
- Strong knowledge of oncology landscape and Medical Affairs roles within pharmaceutical industry, including launch activities.
- Keen understanding of GCP, statistics, clinical trial designs and commercial success factors.
Job Location: Cambridge, MA
Please send resumes to email@example.com