Executive Director of Clinical Development

Executive Director of 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.