Medical Director, Experimental Medicine Job at BioMarin Pharmaceutical

Job Description

Fully remote role, US based candidates only. BioMarin’s EXPERIMENTAL MEDICINE team is seeking a physician scientist to serve as a key matrixed clinical leader focused on the preclinical planning, execution, and design and execution of highly informative first-in-human clinical experiments. Leveraging deep experience in biomarkers and translational clinical research, the Medical Director will partner with Preclinical Pharmacology, Biology, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory and Clinical Operations colleagues to ensure that BioMarin assets are optimally positioned at the time of IND filing to inform a well-designed clinical strategy. Clinical Development plans will be designed 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 informing appropriate preclinical data requirements prior to IND, 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

As a member of preclinical project teams, inform preclinical experimental plans for in vitro and in vivo pharmacology and toxicology packages
Develop biomarker strategy for preclinical assets and inform execution of experiments to inform their downstream clinical usage in advance of asset entry to the clinic
Formulate clinical development plans that serve as the strategic basis for full clinical development of an asset, with particular emphasis on demonstrating proof of mechanism in first in human and first in patient clinical trials as well as subsequent demonstration of proof of concept in the clinic
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
Design and execute natural history studies that enable (1) deepened understanding of proposed targeted patient populations and (2) development of endpoints that enable efficient demonstration of POC and/or approval
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
Serve as Medical Monitor on BioMarin clinical trials

Requirements

MD required
MD/PhD preferred
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

What we offer

company-sponsored medical, dental, vision, and life insurance plans
paid time off
discretionary annual bonus
discretionary stock-based long-term incentives

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Medical Director, Experimental Medicine

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