Senior Medical Director, Early Clinical Development

Overview
- Serve as Senior Medical Director for BioMarin’s Early Clinical Development (ECD), shaping and executing early clinical development strategies across one or more early pipeline assets.

Responsibilities
Clinical Strategy and Leadership
- Develop clinical development plans emphasizing proof of mechanism in first-in-human/first-in-patient studies and proof of clinical concept.
- Act as Clinical Development Team Leader (CDTL) from research phase through completion of human POC studies.
- Provide scientific/clinical leadership across multiple assets; balance priorities and resources.
- Recommend at key development and governance decision points using safety, efficacy, and benefit-risk considerations.

Clinical Development Execution
- Lead clinical contributions to pre-IND, IND, and other appropriate regulatory submissions.
- Collaborate to integrate innovative experimental designs for strategy and regulatory filings.
- Serve as Medical Monitor on selected studies as appropriate.

Translational and Biomarker Strategy
- Design and execute natural history studies to deepen patient-population understanding and develop endpoints supporting efficient POC and/or regulatory approval.
- Partner with Biomarkers and Clinical Pharmacology on patient selection, pharmacodynamic assessments, response biomarkers, and potential approval endpoints.

Portfolio, Talent, and Organizational Development
- Provide matrixed leadership/mentorship to ECD colleagues; may directly manage more junior Medical Directors.
- Define ECD capability needs and contribute to recruitment, training, and retention.
- Establish/evolve ECD SOPs, decision frameworks, and best practices.

Business Development Support
- Support new project identification and business development assessments as a clinical expert.

Note: Duties may include other assigned responsibilities.