Senior Director, Program Leader

Role: Strategic Program Leader accountable for a late-stage clinical asset in rare diseases, overseeing its development, regulatory approval, and lifecycle management. Responsibilities include defining and executing a fully integrated global strategy, leading cross-functional teams spanning clinical development, regulatory, medical, commercial, and manufacturing, and engaging with external stakeholders such as regulators, KOLs, and partners. The role involves managing program risks, securing resources, and aligning development plans with corporate objectives. Requirements: advanced degree (MD, PhD, PharmD, MBA), 10+ years in biopharma with experience leading late-stage or registration programs, and proven success in product launch, lifecycle management, and regulatory interactions, particularly with FDA and EMA. Preferred skills include deep expertise in drug development across multiple domains, global program leadership, strong business acumen, and exceptional communication skills. High-Value: rare disease focus, global regulatory strategy, late-stage development, lifecycle management, cross-functional leadership, and stakeholder engagement. Work setup: hybrid at Cambridge HQ with less than 3 days onsite, some travel expected.