Executive Director, Clinical Development
Location: Onsite - Alameda, CA
Job Type: Full-time
About the Opportunity:
A high-growth clinical-stage biotechnology company is seeking a strategic and hands-on Executive Director of Clinical Development to lead its first-in-class cell therapy program.
This is a foundational leadership role for a physician executive who thrives in fast-paced, innovative environments and has deep experience in early-phase clinical development, particularly in autoimmune, rheumatology, immunology, and/or cell therapy.
Key Responsibilities:
Lead the clinical development strategy for the company's lead program, beginning with a Phase 1 study in autoimmune disease.
Design and oversee clinical trials, including protocol development, safety monitoring, and data interpretation.
Serve as a senior clinical voice across regulatory submissions, internal planning, and external engagements.
Collaborate with translational science, regulatory affairs, clinical operations, and research to integrate clinical strategy across functions.
Guide biomarker and endpoint strategy to support both mechanistic and clinical insights.
Act as the primary liaison with investigators, key opinion leaders, and regulatory authorities (e.g., FDA).
Build and lead a high-performing clinical team to support ongoing and future programs.
Qualifications:
MD, PharmD or PhD with progressive industry experience in biotech or pharma clinical development.
Strong scientific background in autoimmune diseases.
Experience in early clinical development, particularly Phase 1-2 trials; IND authorship and regulatory interaction required.
Familiarity with cell therapy, antibody-based therapies, or other advanced biologics highly desirable.
Demonstrated leadership in cross-functional collaboration and clinical trial execution.
Strong communication and interpersonal skills; capable of influencing both internal and external stakeholders.
What We Offer:
The opportunity to shape and lead a clinical development function from the ground up.
A collaborative and mission-driven environment focused on delivering innovative therapies to patients.
Competitive compensation and a leadership seat at the table during a high-impact growth phase.
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