Senior VP, Oncology Clinical Development (Remote/Hybrid)

BayBridge; Massachusetts; Hybrid; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

BayBridge is seeking a VP Clinical Development to lead strategy across its oncology portfolio. Based in Boston/Cambridge with hybrid work or US remote, you will steer IND through Phase 3 and registration, align development plans with FDA expectations, and shape go/no-go decisions at critical milestones.

You will build a high-caliber clinical development team, manage global Phase 1–3 programs, interact with regulators, and collaborate with BD on partnerships while advancing assets toward

Qualifikationen

• MD is required and board status is preferred.
• 8+ years in oncology clinical development.
• Track record taking assets from IND to Phase 3 go decision.
• Experience with NSCLC and/or GI tumors.
• Experience with targeted small molecules and antibodies including IO combos.
• Exposure to BD, partnering and asset licensing.
• A publication and congress record (ASCO/ESMO/AACR).

Aufgaben

• Own the clinical development strategy across the oncology portfolio from IND through Phase 3 and registration.
• Lead dose optimisation, indication prioritisation and IO combination strategy aligned with FDA expectations.
• Drive go/no-go decisions at PCC-to-FIH, Phase 2 and Phase 3 backed by data.
• Lead FDA interactions, including pre-IND, IND, and pre-NDA/BLA meetings and prepare briefing packages.
• Provide medical and safety monitoring oversight across global Phase 1–3 studies.
• Build and mentor a clinical development team and external advisory networks.
• Partner with BD on due diligence, licensing and co-development partnerships.

Kenntnisse

Oncology development

IND–to–Phase3 leadership

FDA interactions

IO combinations

BD & partnerships

KOL & advisory networks

Ausbildung

MD

Jobbeschreibung

BayBridge is seeking a VP Clinical Development to lead strategy across its oncology portfolio. Based in Boston/Cambridge with hybrid work or US remote, you will steer IND through Phase 3 and registration, align development plans with FDA expectations, and shape go/no-go decisions at critical milestones.

You will build a high-caliber clinical development team, manage global Phase 1–3 programs, interact with regulators, and collaborate with BD on partnerships while advancing assets toward