Director, Medical Affairs, Rare Disease

Ipsen Biopharmaceuticals Inc.; Cambridge (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. seeks a Director, Medical Affairs for Rare Disease to lead medical strategy for pediatric cholestatic diseases, with potential support for adult populations.

You will guide cross‑functional teams and serve as medical leader for the therapeutic area. The role drives US Medical Affairs strategy, advisory board planning, scientific communications, and the design and oversight of US‑based clinical studies, while reviewing promotional and medical materials to ensure

Responsibilities

• Lead Medical Affairs activities aligned with US/Global Rare Disease strategy.
• Oversee medical information responses and publications.
• Plan and execute advisory boards (national and regional).
• Guide field medical strategy with MSL team and key opinion leaders.
• Review promotional and medical materials for compliance.

Job description

Title

Director, Medical Affairs, Rare Disease

Company

Ipsen Biopharmaceuticals Inc.

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description

WHAT - Summary & Purpose of 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. While primarily focused on Pediatric Cholestatic Rare Disease, this role may also support Adult Cholestatic Rare Disease populations as needed. 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.

WHAT - Main Responsibilities & Technical Competencies

• 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, with support for adult cholestatic populations as needed.
• 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 provid