Director, Medical Affairs, Rare Disease

Ipsen•Cambridge, MA

3d•$225,000 - $300,000•Hybrid

About The Position

The Director, Medical Affairs, is responsible for leading and overseeing key Medical Affairs activities in alignment with the US and Global Rare Disease strategy for Pediatric Cholestatic Rare Disease. This role serves as a primary medical and scientific leader for the therapeutic area, providing guidance to internal and external stakeholders and ensuring alignment across cross functional teams. The Director leads the development and execution of the US Medical Affairs strategy and overall medical plan for pediatric cholestatic diseases. Key responsibilities include leading Medical Strategic Team activities, advisory board planning and execution, and cross functional collaboration to ensure integration of medical strategies. The role also includes oversight of medical information responses (in collaboration with Medical Information), scientific communications (including publications and congress presentations in partnership with the Publication team), and the design and medical oversight of US based clinical studies, as well as the review and approval of promotional and medical materials and educational grants. The Director works closely with the Medical Science Liaison team to guide field medical strategy, develop and maintain relationships with key opinion leaders, and incorporate field insights into medical planning. Additional responsibilities include assessing investigator sponsored study requests, supporting internal and external training through knowledge transfer, and ensuring accurate, timely responses to medical information requests. Key internal partners include US and Global Medical Affairs, Clinical Operations, the Rare Disease commercial team, and global Rare Disease franchise medical personnel.

Requirements

8+ years of experience in the pharmaceutical industry, including 5–8 years in Medical Affairs strategy
Significant experience in Rare Disease required; experience in Liver or Gastroenterology is an asset.
Knowledge of clinical trial design, biostatistics.
Experience in presenting and publishing scientific information.
Ability to work across multiple functions & cultures & embrace team diversity.
Enterprise and strategic with ability to identify & create solutions to various scenarios.
Strong verbal & written communication skills, presentation, & coaching skills.
Excellent interpersonal skills & problem-solving capabilities.
Experience with organizational skills & business planning.
Proven project management, tracking & reporting of outcomes.
Strong organizational skills & ability to deal with competing priorities.
Strong reasoning & creative solving skills.
Strong knowledge of US PhRMA, OIG, FDA rules & regulations & guidelines relating to compliant medical engagements
Proven ability to work in & embrace a fast-paced & dynamic work environment with a high level of autonomy.
Ability to travel up to 40% of the time i.e., Attend HCP/customer meetings; attend scientifical/medical conferences, attend Cambridge, MA meetings, etc.)
Advanced degree in a scientific discipline (MD, PhD, or PharmD) required.
Fluent in English.

Nice To Haves

Clinical trials/research experience is a plus.

Responsibilities

Through Medical Affairs Information and the MSL team, ensure the development and dissemination of medically sound information to support the safe and effective use of Bylvay in accordance with Ipsen and regulatory guidelines.
Contribute to the planning and budget oversight of medical activities for pediatric cholestatic diseases.
Develop and maintain relationships with key opinion leaders and external stakeholders to gather insights and inform medical strategy.
Serve as the medical and scientific representative on disease area and asset cross functional teams, ensuring alignment across stakeholders.
Provide medical and scientific leadership to cross functional teams, integrating insights to inform strategy and execution.
Lead, when appropriate, content development and presentation for external medical education programs
Lead the planning and execution of advisory boards (national and regional).
Ensure appropriate scientific, disease, and Ipsen product training for the MSL team and other internal partners, in collaboration with Knowledge Transfer.
Review and approve promotional and medical materials (PRC and MRC, as applicable).
Identify needs and provide directions on the development of proactive and reactive field medical materials (e.g., FAQs, medical objection handlers, advisory board content) in collaboration with field teams.
Contribute to the US scientific publication strategy planning and oversee clinical study design and execution in collaboration with Medical Affairs Operations.
Oversee the development and execution of the Rare Disease KOL identification strategy and process.
Lead medical congress strategy and execution, including scientific exchange and congress coverage.
Lead Medical Strategic Team activities, ensuring alignment with US and Global Rare Disease medical strategy.
Oversee clinical grants and medical education funding activities, including providing medical input and budget management in collaboration with the Grants Manager.
Manage travel and expense budget in line with Ipsen guidelines.
Ensure compliance with all applicable laws, regulations, and Ipsen policies.