Senior Medical Director, Early Clinical Development

Key Responsibilities

• Develop clinical development plans that serve as the strategic foundation for full development of assigned assets, with emphasis on demonstrating proof of mechanism first-in-human and first-in-patient studies, and subsequent demonstration of clinical proof of concept.
• Serve as clinical development team leader (CDTL) for assets from the research phase through completion of human POC studies.
• Provide scientific and clinical leadership across multiple assets, balancing strategic priorities and resource allocation.
• Make recommendations at key development and governance decision points, incorporating safety, efficacy, and benefit-risk considerations.
• Lead clinical contributions to pre-IND, IND, and other stage-appropriate regulatory submissions.
• Collaborate with Research and Translational Science colleagues to integrate innovative experimental designs that inform clinical development strategy and regulatory filings.
• Serve as Medical Monitor on selected studies, as appropriate.
• Translational and Biomarker Strategy Design and execute natural history studies to (1) deepen understanding of targeted patient populations and (2) enable development of endpoints that support efficient demonstration of POC and/or regulatory approval.
• Partner with Biomarker and Clinical Pharmacology colleagues to ensure robust plans for 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 capability needs for the ECD function and contribute to recruitment, training, and retention strategies.
• Establish and evolve standard operating procedures, decision frameworks, and best practices across the ECD organization.

Note

This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.