Director, Medical Affairs, Rare Disease

Director, Medical Affairs, Rare Disease

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!

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 Adult 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 adult 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.

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 Elafibranor in accordance with Ipsen and regulatory guidelines.
• Contribute to the planning and budget oversight of medical activities for adult 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.

Knowledge & Experience:

• 8+ years of experience in the pharmaceutical industry, including 5–8 years in Medical Affairs strategy
• Significant Rare Disease experience required; Liver or Gastroenterology experience preferred.
• 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.).

Education / Certifications (essential):

• Advanced degree in a scientific discipline (MD, PhD, or PharmD) required.

Language(s) (essential):

• Fluent in English.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is $225,000-$300,000.

This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.