Vice President Clinical Development

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