Vice President Clinical Development

Kaye/Bassman International; Boston (MA); Presencial; USD 300.000 - 520.000; Jornada completa

Descripción de la vacante

Kaye/Bassman International is partnering with a clinical-stage immuno-oncology biotech to search for a Vice President, Clinical Development in the Boston area. The leader will set strategic clinical direction for global oncology programs, focusing on next-generation checkpoint inhibitor combinations advancing into registrational Phase 3 in gastrointestinal tumors.

This senior role combines strategic oversight with hands-on medical monitoring, data review, and cross-functional leadership across

Formación

• MD degree or international equivalent with oncology/biotech expertise.
• 8+ years in biotech/pharma clinical development, with sponsor-side oncology experience.
• Experience leading programs from design through Phase 3 and regulatory submissions.
• Immuno-oncology experience with checkpoint inhibitors preferred.
• Strong leadership, communication, and ability to influence at senior leadership level.

Responsabilidades

• Lead clinical development strategy across early- to registrational programs.
• Translate efficacy, safety, biomarker data into development decisions.
• Provide clinical leadership for Phase 3 execution and regulatory submissions.
• Serve as Medical Monitor for trials and oversee safety surveillance.
• Lead data review with Clinical Operations, Data Management, Biostatistics.
• Author protocols, investigator brochures, clinical study reports, and regulatory sections.
• Represent Clinical Development with senior leadership, KOLs, investigators, and health authorities.
• Present to DSMBs, steering committees, and support abstracts.
• Mentor the Clinical Development team and partner cross-functionally.

Conocimientos

Strategic leadership

Clinical development strategy

Oncology drug development

Cross-functional leadership

Regulatory submissions

Educación

MD or international equivalent

Descripción del empleo

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