BioSpace
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, we have applied our scientific expertise to transform genetic conditions into transformative medicines, leveraging genetics and molecular biology to develop therapies for patients with significant unmet needs.
Medical Director, Experimental Medicine As a key matrixed clinical leader, the Medical Director will design and execute highly informative first‑in‑human clinical experiments. Leveraging deep experience in translational clinical research, you will partner across Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory, and Clinical Operations to position BioMarin assets for maximal insight during initial clinical experiences with new therapeutic agents.
Job Summary
Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset, emphasizing proof of mechanism in first‑in‑human and first‑in‑patient trials and subsequent proof of concept.
Lead the clinical development team for assets from the research phase through Phase 1 trial completion.
Contribute to pre‑IND and IND submissions and other stage‑appropriate regulatory submissions.
Develop Phase 1 study protocols and related trial documents.
Serve as Medical Monitor for Phase 1 trials.
Design and execute natural history studies to deepen understanding of target patient populations and develop endpoints for efficient proof of concept and approval.
Partner with Biomarker colleagues to ensure patient selection, pharmacodynamic, response, and approval endpoint plans are in place for each asset.
Provide clinical expertise to support new project identification, both internal programs and business development opportunities.
Represent Experimental Medicine in scientific advisory and academic meetings.
Qualifications
MD or MD/PhD required.
5+ years of hands‑on experience leading IND filings and Phase 1 clinical trials in industry, CROs, or Phase 1 units.
Experience with Phase 2 clinical trials preferred, with demonstrated clinical POC.
Proven experience leading clinical development teams and developing clinical development plans.
Ability to work collaboratively in a matrixed, fast‑paced environment.
Strong communication skills and a desire to build internal and external collaborations.
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Medical Director, Experimental Medicine As a key matrixed clinical leader, the Medical Director will design and execute highly informative first‑in‑human clinical experiments. Leveraging deep experience in translational clinical research, you will partner across Experimental Medicine, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory, and Clinical Operations to position BioMarin assets for maximal insight during initial clinical experiences with new therapeutic agents.
Job Summary
Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset, emphasizing proof of mechanism in first‑in‑human and first‑in‑patient trials and subsequent proof of concept.
Lead the clinical development team for assets from the research phase through Phase 1 trial completion.
Contribute to pre‑IND and IND submissions and other stage‑appropriate regulatory submissions.
Develop Phase 1 study protocols and related trial documents.
Serve as Medical Monitor for Phase 1 trials.
Design and execute natural history studies to deepen understanding of target patient populations and develop endpoints for efficient proof of concept and approval.
Partner with Biomarker colleagues to ensure patient selection, pharmacodynamic, response, and approval endpoint plans are in place for each asset.
Provide clinical expertise to support new project identification, both internal programs and business development opportunities.
Represent Experimental Medicine in scientific advisory and academic meetings.
Qualifications
MD or MD/PhD required.
5+ years of hands‑on experience leading IND filings and Phase 1 clinical trials in industry, CROs, or Phase 1 units.
Experience with Phase 2 clinical trials preferred, with demonstrated clinical POC.
Proven experience leading clinical development teams and developing clinical development plans.
Ability to work collaboratively in a matrixed, fast‑paced environment.
Strong communication skills and a desire to build internal and external collaborations.
#J-18808-Ljbffr