Medical Director, Experimental Medicine

Role Summary

BioMarin’s Experimental Medicine team is seeking an experienced Medical Director to serve as a key matrixed clinical leader focused on the design and execution of highly informative first-in-human clinical experiments. The Medical Director will partner with Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory and Clinical Operations colleagues to ensure assets are positioned to gain maximal insights during initial clinical experiences with new therapeutic agents. Key contributions include delivery of initial clinical development plans, preIND and IND documents, and well-designed clinical trial protocols and supportive documents. The role will contribute to clinical assessments of new project opportunities (internal projects and supporting business development activities).

Responsibilities

• Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset, with emphasis on demonstrating proof of mechanism in first-in-human and first-in-patient trials and subsequent demonstration of proof of concept in the clinic.
• Serve as clinical development team lead for assets from the research phase through Phase 1 trial completion.
• Lead clinical contributions to pre-IND and IND submissions (and other stage-appropriate regulatory submissions).
• Lead clinical contributions to Phase 1 study protocols and trial-related documents.
• Serve as Medical Monitor on Phase 1 trials.
• Design and execute natural history studies to deepen understanding of targeted patient populations and to develop endpoints for efficient demonstration of POC and/or approval.
• Partner with Biomarker colleagues to ensure patient selection, pharmacodynamic, response, and approval endpoint development plans are in place for each asset.
• Serve as clinical expert to aid new project identification (internal programs and business development opportunities).
• Represent Experimental Medicine in scientific advisory and academic meetings.

Qualifications

• MD or MD/PhD required.
• Significant demonstrated experience with IND filings and Phase 1 trial clinical leadership (5+ years of hands-on industry experience).
• Demonstrated experience in Phase 1 clinical trials in industry (pharmaceutical/biotech companies, CROs, or Phase 1 trial units).
• Experience with Phase 2 clinical trials is preferred (and demonstration of clinical POC).
• Experience leading clinical development teams.
• Experience with clinical development plans.
• Ability to work collaboratively in a matrixed, fast-paced environment.
• Interest and curiosity in development challenges.
• Effective and impactful in cross-functional team structure.
• Excellent communication skills, with a desire to develop strong internal and external collaborations.

Education

• MD or MD/PhD required.

Additional Requirements

• None specified beyond qualifications.