Medical Director, Early Clinical Development

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.

Bio Marin’s Early Clinical Development team is seeking an experienced Medical Director to serve as a key matrixed clinical leader focused on the design and execution of highly informative Phase 1 and Phase 2 trials. This role is central to translating early scientific insights into clinical strategies that maximize learning in first‑in‑human and early patient studies, enabling efficient progression to proof of concept.

Leveraging experiences in translational clinical research and early‑phase trial design, the Medical Director will develop early clinical strategies and development plans that establish the foundation for full program advancement, while leading protocol design, clinical oversight of execution, and medical monitoring to deliver high‑quality, insight‑rich trials. The role requires close collaboration across Research, Translational Sciences, and Development, along with external engagement in scientific, regulatory, and advisory settings.

The role partners closely with colleagues in Early Clinical Development, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory, and Clinical Operations to ensure Bio Marin’s assets are optimally positioned to generate high‑value insights that inform downstream development and regulatory strategy. A strong focus is placed on embedding translational science, biomarkers, and experimental medicine approaches into clinical programs to deepen mechanistic understanding and inform development decisions.

In parallel, the Medical Director mentors colleagues and contributes to organizational capability building. Additionally, the role supports evaluation of internal and external opportunities by providing clinical and scientific insight for business development decision‑making. Through a combination of individual contribution and cross‑functional leadership, this position has broad impact across Bio Marin’s early clinical portfolio.

• Clinical Strategy and Leadership
  • Develop and lead clinical development plans that establish the strategic foundation for full clinical development of assets.
  • Define strategies to demonstrate proof of mechanism in early clinical trials and enable proof of concept in subsequent studies.
  • Translate overarching program strategy into actionable clinical plans and study designs.
  • Lead clinical strategy contributions to pre‑IND, IND, and other regulatory submissions.
  • Provide clinical leadership and decision‑making within matrixed program teams.
  • Lead clinical efforts for 1 to 2 assets (in general).
• Clinical Development Execution
  • Lead the design and execution of Phase 1 and Phase 2 clinical study protocols and associated trial documentation.
  • Serve as Medical Monitor for selected studies, ensuring appropriate oversight of safety, study conduct, and data interpretation.
  • Design and execute natural history studies to:
    • Enhance understanding of target patient populations.
    • Enable development of clinically meaningful endpoints supporting POC and regulatory approval.
  • Ensure studies are designed to maximize clinical, pharmacologic, and mechanistic insights.
• Cross‑Functional and External Engagement
  • Partner closely with Early Clinical Development, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory Affairs, and Clinical Operations to align on development strategy and execution.
  • Represent Early Clinical Development in health authority interactions, scientific advisory boards, and academic and external meetings.
  • Act as a key matrix clinical leader, ensuring alignment across cross‑functional stakeholders.
• Translational and Biomarker Strategy
  • Integrate translational science and experimental medicine approaches into early clinical development programs.
  • Partner with Biomarker teams to define and implement strategies for patient…