Senior Medical Director, Clinical Science

Description Who We Are Bio Marin  is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of Bio Marin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

Overview Bio Marin ’s Clinical Science team is seeking an accomplished Senior Medical Director to serve as a senior clinical leader responsible for shaping and executing late-stage clinical development strategy for one or more assets. This role encompasses end-to-end clinical leadership from pivotal study design through regulatory approval and lifecycle management, with accountability for scientific rigor, strategic clarity, and development decision-making as programs advance toward registration and beyond.

Leveraging deep expertise in rare disease drug development, the Senior Medical Director will lead integrated clinical development planning, direct the design and execution of registrational studies, and guide key investment and governance decisions based on emerging safety, efficacy, and benefit-risk data.

The role partners closely with colleagues in Regulatory Affairs, Clinical Operations, Biometrics, Clinical Pharmacology, Pharmacovigilance, Medical Affairs, and Commercial to ensure Bio Marin’s late-stage assets are positioned to deliver differentiated value to patients and meet global regulatory  addition to asset-level leadership, the Senior Medical Director will contribute broader portfolio-level clinical perspective, support evaluation of internal programs and external business development opportunities, and provide mentorship and leadership within the Clinical Science organization.

This position is expected to interact regularly with senior governance bodies, global health authorities, and external scientific experts, and to represent Bio Marin as a thought leader in the therapeutic area.

Key Responsibilities Clinical Strategy and Leadership
* Own the clinical development strategy for one or more assets (asset-level rather than study-level accountability), developing Clinical Development Plans (CDPs) aligned with overall product strategy and corporate objectives.
* Serve as clinical development team leader (CDTL) for assigned programs through registration and lifecycle management.
* Drive clinical strategy discussions with senior management and participate in Program Review Committee and Development Governance, making recommendations at key decision points that incorporate safety, efficacy, and benefit-risk considerations.
* Identify opportunities to accelerate timelines, optimize study designs, and mitigate program risks, ensuring alignment with the evolving scientific, medical, regulatory, and commercial landscape.

Regulatory Leadership
* Lead the development of regulatory strategy in partnership with Regulatory Affairs and represent Clinical Science in interactions with global health authorities (e.g., FDA, EMA, PMDA).
* Lead preparation for and participation in key regulatory milestone meetings, including End-of-Phase 2, Breakthrough Therapy, Accelerated Approval pathway discussions, and BLA/NDA/MAA preparation.
* Lead authoring and review of major regulatory documents, including CDPs,…