Vice President, Head of US Medical Affairs, Rare Disease

Job description

Title: Vice President, Head of US 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: Summary & Purpose of the Position The Vice President, Head of US Medical Affairs, Rare Disease is accountable for setting the U.S. Rare Disease medical vision, strategy and execution across Ipsen's evolving rare disease portfolio, with core leadership in rare liver disease and close partnership on rare bone and newly emerging rare kidney / transplant priorities. The role spans marketed products, post-launch optimization, lifecycle management, evidence generation, pipeline evaluation, business development due diligence, and integration planning for acquired or partnered assets. The VP acts as the senior U.S. medical leader and strategic partner to the Rare Disease franchise, Global Medical Affairs, R&D, Regulatory, Commercial, Market Access, HEOR/RWE, Field Medical, Medical Operations & Engagement, Patient Affairs, Corporate Affairs and Business Ethics. This leader is expected to bring the U.S. medical voice early into global asset and evidence decisions; translate customer, patient, payer, field and competitive insights into practical strategy; and elevate issues with executive-level clarity, judgment and speed. Current strategic priorities include post-launch optimization and evidence pull-through for IQIRVO in PBC; ongoing lifecycle and evidence strategy for IQIRVO including PSC where applicable; Bylvay / Kayfanda growth and launch-readiness work across PFIC, ALGS and biliary atresia; continued support for the FOP community through Sohonos and appropriate FALKON / fidrisertib close-out and inquiry management; and preparation for rare kidney / BK polyomavirus-associated nephropathy medical strategy and integration planning following Ipsen's announced acquisition of Memo Therapeutics AG's anti-BK polyomavirus business and potravitug program, subject to transaction close. Main Responsibilities & Technical Competencies Set and own the U.S. Rare Disease medical strategy, annual medical plan and integrated evidence / engagement roadmap across rare liver, rare bone and emerging rare kidney / transplant priorities, ensuring alignment with North America priorities and Global Medical / Asset strategy. Drive post-launch medical excellence for IQIRVO in PBC, including insight generation, evidence pull-through, scientific differentiation, guideline / competitive readiness, patient and HCP education, access-supporting medical evidence, and disciplined follow-up on post-approval commitments or label-related developments as applicable. Lead launch readiness and lifecycle medical planning for Bylvay / Kayfanda across PFIC, ALGS and biliary atresia, with strong coordination across medical, commercial, market access, patient affairs and global teams. Plan for and support U.S. medical strategy for new rare disease assets and adjacencies, including rare kidney / BKPyV-associated nephropathy and the potravitug program, with a clear distinction between pre-close planning, transition planning and post-close integration responsibilities. Maintain appropriate medical oversight for the FOP portfolio and community, including Sohonos medical strategy and compliant coordination of fidrisertib / FALKON close-out, inquiry handling, patient / HCP communications and lessons learned for future rare disease development. Represent the U.S. medical voice in Global Asset Teams, Global Rare Disease Medical forums, brand planning, launch readiness reviews and cross-functional governance bodies; proactively shape strategy rather than react to decisions made elsewhere. Provide end-to-end leadership over evidence generation, including U.S. Phase IIIb / IV studies, RWE / HEOR priorities, investigator-sponsored studies, registries, medical education, external scientific collaborations and U.S. support for R&D or Global Medical sponsored studies. Ensure rigorous medical governance and oversight of studies and proposals moving through EGRB, GRC, MRC / PRC or other relevant governance processes, with timely medical input, clear accountability and risk mitigation. Lead a fit-for-purpose U.S. Rare Disease Medical Affairs organization with clear asset ownership, equitable workload distribution, strong succession planning, talent development and direct coaching of senior medical leaders. Partner closely with Field Medical leadership to connect MSL strategy, scientific training, insight generation, metrics, dashboards and feedback loops to Medical Strategy Team priorities and executive-level decision-making. Build trusted relationships with R&D, Regulatory, Commercial, Market Access, Patient Affairs, Corporate Affairs, Business Ethics, Medical Operations & Engagement, Medical Information / Patient Safety, HEOR / RWE and Global Medical to enable disciplined, proactive cross-functional execution. Oversee scientific communication, publication strategy, congress planning, medical education and external scientific collaborations to strengthen Ipsen's reputation as a respected scientific leader and trusted long-term partner in rare disease. Translate scientific, KOL, field, patient, competitive, guideline and payer insights into actionable strategies, executive-ready recommendations and high-impact materials for NALT / ELT / MALT and other senior forums. Maintain high-quality, timely communication on critical external developments, including guideline updates, competitive data, regulatory / label implications, congress insights, study outcomes and emerging evidence that may affect business or medical strategy. Support medical input into business development, external innovation, acquisitions and integration activities for rare disease assets, ensuring U.S. medical implications, evidence needs, stakeholder landscape, capability requirements and launch / post-launch requirements are assessed early. Ensure all medical activities are conducted ethically, compliantly and in accordance with Ipsen policies, regulatory requirements and industry standards, while role-modeling patient-first decision making and enterprise leadership. Drive operational excellence by prioritizing high-impact work, establishing clear KPIs, leveraging technology / automation / AI where appropriate, and continuously simplifying processes to improve quality, speed and resource discipline. Knowledge & Experience Knowledge & Experience (essential): MD, PharmD or PhD with deep scientific credibility; advanced clinical / scientific training strongly preferred. MD preferred for roles requiring significant external medical representation. 15+ years of pharmaceutical / biotechnology experience, including substantial Medical Affairs leadership experience in the U.S.; rare disease, hepatology / cholestatic liver disease, transplant / nephrology, pediatrics, bone disease or orphan-drug experience strongly preferred. Demonstrated VP-level or senior enterprise leadership experience leading asset strategy, post-launch optimization, launch readiness and lifecycle management for complex specia