Medical Director, Early Clinical Development

About the role

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)
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.

Responsibilities

• 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.
• Integrate translational science and experimental medicine approaches into early clinical development programs.
• Partner with Biomarker teams to define and implement strategies for patient selection, pharmacodynamic assessments, response biomarkers, and endpoints supporting approval pathways
• Ensure programs are positioned to generate deep mechanistic and translational insights during early clinical studies.
• Mentor and develop junior colleagues across Early Clinical Development and Biomarkers functions.
• Contribute to building organizational capability in early clinical strategy and execution.
• Foster a culture of scientific rigor, collaboration, and continuous learning within the early development organization.
• Serve as a clinical expert to support internal program prioritization and external business development opportunities.
• Provide scientific and clinical assessments of new assets, including risks, differentiation, and development feasibility.
• Deliver recommendations to senior leadership to inform decision-making on new project opportunities.

Requirements

• MD or MD/PhD required.
• ≥5 years of industry experience in Phase 1/2 clinical development, with demonstrated ownership of at least two assets from IND through proof of concept.
• Significant experience contributing to IND submissions.
• Demonstrated expertise in:
• Phase 1 clinical trials (industry, CRO, or Phase 1 units)
• Phase 2 trials and clinical proof-of-concept generation
• Experience leading cross-functional clinical development teams and developing clinical development strategies.
• Strong ability to operate effectively in a matrixed, fast-paced environment.
• Demonstrated collaboration and communication skills, including engagement with internal and external stakeholders.
• Intellectual curiosity and interest in addressing complex development challenges.

Qualifications

• MD or MD/PhD required.
• ≥5 years of industry experience in Phase 1/2 clinical development, with demonstrated ownership of at least two assets from IND through proof of concept.
• Significant experience contributing to IND submissions.
• Demonstrated expertise in:
• Phase 1 clinical trials (industry, CRO, or Phase 1 units)
• Phase 2 trials and clinical proof-of-concept generation
• Experience leading cross-functional clinical development teams and developing clinical development strategies.
• Strong ability to operate effectively in a matrixed, fast-paced environment.
• Demonstrated collaboration and communication skills, including engagement with internal and external stakeholders.
• Intellectual curiosity and interest in addressing complex development challenges.

Skills

• Strong clinical development and regulatory expertise.
• Ability to lead cross-functional teams.
• Excellent communication and collaboration skills.
• Experience with translational science and experimental medicine.
• Knowledge of biomarker development and implementation.
• Experience with natural history studies.

Benefits

Not specified.

Pay

Not specified.

Schedule

This is a virtual position unless you live within 100 miles of our Headquarters in San Rafael, CA (zip: 94901). If so, the role changes to hybrid requiring an onsite presence 2 times per week.

Company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Website

https://www.biomarin.com/

Location

San Rafael and Novato, California, US