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Director/Sr. Director, Clinical Development
Job description
Director/Sr. Director, Clinical Development & Medical Affairs
Location: San Francisco Bay Area – Hybrid (Relocation considered)
Employment Type: Full-time | Permanent
Overview:
Key Responsibilities:
Required:
Nice-to-Have:
Location: San Francisco Bay Area – Hybrid (Relocation considered)
Employment Type: Full-time | Permanent
Overview:
An innovative, well-funded clinical-stage biotech is seeking a Director of Clinical Development with experience in Medical Affairs. This individual will play a critical role in shaping and executing clinical development strategy while also serving as a key external-facing leader engaging with KOLs, investigators, and strategic stakeholders.
The position is ideal for someone energized by smaller biotech environments—where collaboration, communication, and cross-functional impact are the norm. This is a high-visibility role that combines strategic and operational responsibilities across multiple therapeutic areas, starting with support for Phase 2+ clinical trials.
Key Responsibilities:
- Lead clinical study teams and collaborate with investigators and CROs to design and execute Phase 1–3 clinical trials.
- Author and review clinical protocols, investigator brochures, study reports, and other regulatory documents.
- Represent the company in KOL engagements, advisory boards, investigator meetings, and conference presentations.
- Translate early research and translational findings into actionable clinical development plans.
- Support the preparation of abstracts, presentations, and scientific manuscripts.
- Collaborate cross-functionally with Regulatory, Biomarkers, Commercial, and Clinical Operations teams.
- Help ensure adherence to FDA, ICH, and GCP standards, including SOP compliance.
Required:
- Advanced clinical degree: MD, DO, MBBS, or PharmD
- Significant experience (5–10+ years) in drug development, with a proven track record across clinical development and medical affairs
- Expertise in interfacing with KOLs and investigators; excellent public speaking and presentation skills
- Strong interpersonal presence: articulate, thoughtful, personable, and collaborative
- Experience supporting 1–2 (Phase 2+) trials
- Comfort in high-accountability, fast-paced biotech environments
- Must be based in, or willing to relocate to, the San Francisco Bay Area (near Palo Alto/Stanford Life Sciences Campus)
Nice-to-Have:
- Background in rare disease, dermatology, hepatology, or non-malignant hematology
- Familiarity with both early-stage development and medical affairs strategy
- For MDs: completion of post-residency training
- For PharmDs: early experience in a clinical or patient-facing setting