Sr Medical Director, Translational Clinical Development

Senior Medical Director – Early Clinical Development (ECD)

Clinical Strategy and Leadership:
- Develop clinical development plans for assigned assets, emphasizing proof of mechanism (first-in-human/first-in-patient) and subsequent proof of concept.
- Serve as Clinical Development Team Leader (CDTL) from research phase through completion of human POC studies.
- Provide scientific/clinical leadership across multiple assets, balancing 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 stage-appropriate regulatory submissions.
- Collaborate to integrate innovative experimental designs into clinical 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 enable endpoints for efficient POC demonstration 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 and mentorship to Early Clinical Development colleagues.
- May directly manage and develop more junior Medical Directors.
- Define ECD capability needs; contribute to recruitment, training, and retention.
- Establish and evolve SOPs, decision frameworks, and best practices.

Business Development Support:
- Support new project identification, including internal pipeline opportunities and business development assessments.