Executive Director, Clinical Development

Executive Director, Clinical Development

The Executive Director, Clinical Development will serve as the clinical lead for development program(s) and play a critical role in advancing pivotal studies, regulatory strategy, and submission readiness. This physician leader will provide medical and scientific oversight across the program lifecycle, from protocol design and study execution through data interpretation, regulatory interactions, and launch preparation.

This role requires a hands-on clinical development leader who thrives in a fast-paced biotech environment and can partner cross-functionally to drive high-quality execution with urgency.

Key Responsibilities

Clinical Development Leadership

• Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
• Lead development of clinical plans, protocols, amendments, and related study documents.
• Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence.
• Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution.
• Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery.

Medical Monitoring / Safety Oversight

• Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
• Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting.
• Support development of risk mitigation strategies and ensure patient safety remains central throughout program execution.

Regulatory / Submission Support

• Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
• Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules.
• Present clinical data and strategy to regulators, internal governance committees, and senior leadership.

Scientific / Cross-Functional Leadership

• Serve as the key clinical voice on cross-functional program teams.
• Partner with Translational Medicine, Biomarkers, Medical Affairs and Commercial to align development strategy with future launch needs.
• Support publication planning, congress presentations, and external scientific engagement.
• Build strong relationships with KOLs, investigators, and external experts.

Team / Culture Leadership

• Mentor internal team members and external consultants/CRO partners.
• Foster a culture of collaboration, accountability, urgency, and quality.
• Operate effectively in a lean biotech environment where flexibility and ownership are essential.

Experience and Qualifications

• MD or equivalent medical degree required; board certification preferred in