Associate Director, Medical Affairs

Title: Associate Director, Medical Affairs
Location: Cambridge, MA (100% Remote)
Duration: 6 Months+

Summary & Purpose of the Position

• Reporting to the Senior Director, Medical Affairs (Adult Cholestatic Diseases), the Associate Director, Medical Affairs, will support and oversee select medical affairs activities related to biliary atresia.
• This role will contribute to the U.S. medical strategy for elafibranor and the broader Medical Affairs plan for cholestatic diseases. Responsibilities include medical review of non-promotional and promotional content, information responses (in collaboration with Medical Information), scientific communications including poster presentations and publications (in conjunction with the Publication/Medical Communications team), advisory board planning, the design and medical monitoring of US-based clinical studies, and the review and approval of educational grants.
• The Associate Director works with the MSL team in developing and managing regional relationships with Thought leaders (TLs).
• This role will also be responsible for assessing investigator-sponsored study (ISS) requests in collaboration with our local and global Medical teams.
• The candidate will work closely with the Global Training & Capabilities Excellence team to ensure we provide relevant internal training to our teams.
• The Associate Director will also work closely with the US and Global Medical Information teams to ensure Medical Information Response documents are accurate. Key internal partners include all sub-functions within Medical Affairs, commercial team, and global medical cholestatic disease personnel.

Main Responsibilities & Technical Competencies

• Contribute to develop and implement medical strategies that align with organizational goals and objectives.
• Serve as subject matter expert (SME) SME, on medical and/or disease area and asset cross-functional committees, as appropriate.
• Support clinical research projects, including the design, execution, and analysis of clinical trials.
• Contribute to the development of content for external medical education programs and take lead on presentations where applicable.
• Contribute to and lead advisory board planning and execution activities as assigned.
• As a SME, the candidate will be responsible to train internal Medical and cross-functional partners on disease area and client product content
• Review and approval of promotional and medical materials in PRC and MRC, respectively as needed.
• Provide medical input and oversee budgets for clinical grants and medical education support activities, in coordination with the Grants Manager.
• In collaboration with the Medical Communications Director, lead the development high-quality scientific and educational materials (e.g. MSL slide decks, FAQs, medical fact sheets, advisory board content, etc.)
• Contribute to the U.S. scientific publication plan
• Attend relevant congresses to engage in scientific exchange and provide congress coverage
• Support the planning, execution and budget oversight of medical activities for cholestatic diseases
• Excellent verbal and written communication skills to effectively convey complex medical information to diverse audiences.
• Project Management: Strong project management skills to oversee multiple projects simultaneously and ensure timely completion.

Knowledge & Experience:
Knowledge & Experience (essential):

• 5+ years experience in the pharmaceutical industry, primarily within Medical Affairs, with additional exposure to clinical trials and/or research experience is a plus.
• Ability to interact with cross-functional teams

Knowledge & Experience (preferred):

• Experience in Rare Disease or Liver/GI is preferred
• Launching new product/indication
• Experience in presenting and publishing scientific information.

Education / Certifications (essential):

• Advanced degree in a scientific discipline (MD, DO, PhD, or PharmD preferred)

Language(s) (essential):

• Fluent in English

Other Useful Information
Key internal stakeholders: Medical Affairs, Medical Information, GMA, Commercial Teams, etc.
Key external contacts: Thought Leaders (TLs), KOLs, scientific societies & congresses, etc.