Vice President Clinical Development
Kaye/Bassman International · Boston, MA
FULL-TIME
Posted Oct 28, 2026
Job Description
About the role
Kaye/Bassman is partnering with a clinical-stage immuno-oncology biotech on a search for a Vice President, Clinical Development. This leader will provide strategic and medical leadership for the company’s global oncology programs, with a focus on a next-generation checkpoint inhibitor combination advancing into registrational Phase 3 development in a gastrointestinal solid tumor and expanding access globally.
This is a senior role with a hands-on mandate. You will set clinical strategy and stay close to the data and the medical monitoring of the trials.
What you will do
Lead clinical development strategy, study design, and patient population strategy across early- through late-stage and registrational programs
Translate emerging efficacy, safety, biomarker, and competitive data into clear development decisions
Provide clinical leadership for Phase 3 execution and preparation of global regulatory submissions (BLA, NDA, MAA)
Serve as Medical Monitor for assigned trials, overseeing patient safety, ongoing safety surveillance, and protocol questions
Lead clinical data review and interpretation, working with Clinical Operations, Data Management, and Biostatistics
Author and review protocols, investigator brochures, clinical study reports, and the clinical sections of regulatory filings
Represent Clinical Development with senior leadership, governance committees, KOLs, investigators, and health authorities
Present to DSMBs, steering committees, and scientific advisory boards, and support abstracts and manuscripts
Mentor the Clinical Development team and partner cross-functionally with Regulatory, Translational Medicine, Pharmacovigilance, and Biometrics
What you bring
MD or international equivalent
8+ years of biotech or pharma clinical development experience, with significant sponsor-side oncology drug development
Immuno-oncology experience required, ideally with checkpoint inhibitors (CTLA-4, PD-1/PD-L1) or other immune-based therapies
Experience owning a program from study design through database lock, CSR, regulatory submission, and health authority interactions, including Phase 3
Gastrointestinal solid tumor experience is a plus
Proven ability to lead cross-functional teams and influence at the senior leadership level
Comfort with ambiguity, sound medical judgment, and a hands-on approach in a lean, fast-paced biotech environment
Excellent written and verbal communication skills
Kaye/Bassman is partnering with a clinical-stage immuno-oncology biotech on a search for a Vice President, Clinical Development. This leader will provide strategic and medical leadership for the company’s global oncology programs, with a focus on a next-generation checkpoint inhibitor combination advancing into registrational Phase 3 development in a gastrointestinal solid tumor and expanding access globally.
This is a senior role with a hands-on mandate. You will set clinical strategy and stay close to the data and the medical monitoring of the trials.
What you will do
Lead clinical development strategy, study design, and patient population strategy across early- through late-stage and registrational programs
Translate emerging efficacy, safety, biomarker, and competitive data into clear development decisions
Provide clinical leadership for Phase 3 execution and preparation of global regulatory submissions (BLA, NDA, MAA)
Serve as Medical Monitor for assigned trials, overseeing patient safety, ongoing safety surveillance, and protocol questions
Lead clinical data review and interpretation, working with Clinical Operations, Data Management, and Biostatistics
Author and review protocols, investigator brochures, clinical study reports, and the clinical sections of regulatory filings
Represent Clinical Development with senior leadership, governance committees, KOLs, investigators, and health authorities
Present to DSMBs, steering committees, and scientific advisory boards, and support abstracts and manuscripts
Mentor the Clinical Development team and partner cross-functionally with Regulatory, Translational Medicine, Pharmacovigilance, and Biometrics
What you bring
MD or international equivalent
8+ years of biotech or pharma clinical development experience, with significant sponsor-side oncology drug development
Immuno-oncology experience required, ideally with checkpoint inhibitors (CTLA-4, PD-1/PD-L1) or other immune-based therapies
Experience owning a program from study design through database lock, CSR, regulatory submission, and health authority interactions, including Phase 3
Gastrointestinal solid tumor experience is a plus
Proven ability to lead cross-functional teams and influence at the senior leadership level
Comfort with ambiguity, sound medical judgment, and a hands-on approach in a lean, fast-paced biotech environment
Excellent written and verbal communication skills
Additional Details
- City
- Boston
- State
- Massachusetts
- Country
- US
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