Vice President Clinical Development

BayBridge; Massachusetts; Hybrid; USD 250,000 - 350,000; Full time

Job summary

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

Qualifications

• 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).

Responsibilities

• 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.

Skills

Oncology development

IND–to–Phase3 leadership

FDA interactions

IO combinations

BD & partnerships

KOL & advisory networks

Education

MD

Job description

Location: Boston/Cambridge, MA (hybrid) or US remote

Reports to: Chief Medical Officer

The company

Our client is a well-funded, clinical-stage oncology biotech with a pipeline running from first-in-human to late-stage development. It has an asset moving toward registration and a set of earlier small molecule / antibody programs in early development / late preclinical.

They're hiring a VP Clinical Development to lead strategy across the portfolio.

The role

• Own the clinical development strategy across the oncology portfolio, from the IND through Phase 3 and registration.


• Lead dose optimisation, indication prioritisation and combination strategy, aligned with FDA's Project Optimus expectations.


• Drive the go/no-go decisions at PCC-to-FIH, Phase 2 and Phase 3, backed by data the executive team and board can act on.


• Lead FDA interactions, including pre-IND, IND, Type B (end-of-Phase 2 / pre-Phase 3) and pre-NDA/BLA meetings. Author and review briefing packages, the IND and filing dossiers, and agency responses.


• Provide medical and safety monitoring oversight across global Phase 1–3 studies.


• Build and manage KOL and scientific advisory networks, and bring external input into asset and disease-area strategy.


• Partner with BD on due diligence, licensing and co-development partnerships.


• Build and mentor a clinical development team as the pipeline matures.

What you'll bring

• MD


• 8+ years of industry clinical development experience in oncology, spanning big pharma or biotech.


• A track record of taking assets from first-in-human to a Phase 3 go decision, including dose optimisation.


• Solid tumour depth, ideally NSCLC and/or GI (colorectal).


• Experience with targeted small molecules and antibodies, including IO combinations.


• Exposure to BD, partnering and asset licensing.


• A publication and congress record (ASCO, ESMO, AACR).