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BioMarin’s Experimental Medicine team is seeking an experienced Medical Director to serve as a key matrixed clinical leader at BioMarin focused on the design and execution of highly informative first-in-human clinical experiments. Leveraging deep experience in translational clinical research, the Medical Director will partner with Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory and Clinical Operations colleagues to ensure that BioMarin assets are optimally positioned to gain maximal insights during initial clinical experiences with new therapeutic agents. The Medical Director will have widespread impacts on the BioMarin early clinical pipeline. Key contributions will include delivery of initial clinical development plans, preIND and IND documents, and well-designed clinical trial protocols and supportive documents. In addition, this role will contribute to clinical assessments of new project opportunities (both internal projects and supporting business development activities).
Job Responsibility:
Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset
Serve as clinical development team lead for assets in the research phase through Phase 1 clinical trial study 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
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 (both on internal new programs and business development opportunities)
Represent Experimental Medicine in scientific advisory and academic meetings
Requirements:
MD or MD/PhD required
Significant demonstrated experience with IND filings and Phase 1 trial clinical leadership (5+ years of hands-on experience in industry clinical trials)
Demonstrated experience in Phase 1 clinical trials in industry (within pharmaceutical and/or biotech companies, CROs, or Phase 1 trial units)
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
Nice to have:
Experience with Phase 2 clinical trials is preferred (and demonstration of clinical POC)
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans