VP Regulatory
LindusClinical Trials company
United StatesDirector
Balderton Capital
Creandum
Seedcamp
Visionaries Club
Firstminute
Peter Thiel
Leadership & General Management
About the role
TL;DR
Own the regulatory strategy for clinical-stage therapeutic assets.
- •We're looking for an exceptional VP of Regulatory Strategy to own the regulatory pathway for every asset in our portfolio.
- •Key Responsibilities Set and own the regulatory strategy across the portfolio: pathway selection, endpoint and pivotal design implications, designations, and the regulatory shape of each program's value-inflection point.
- •Work closely with the Chief Development Officer, the wider executive team, and a network of external regulatory experts and KOLs.
- •De-risk the regulatory pathway at every stage, from diligence through to exit.
- •Requirements 15+ years in regulatory affairs in biopharma, with at least the last 5 in a senior strategy-owning role.
- •Experience with FDA interactions, including pre-IND, End-of-Phase 2, and Type B/C meetings.
- •Hands-on ownership of major submissions across the development lifecycle: multiple INDs filed and maintained, and involvement in at least one NDA or BLA.
- •Strong grasp of pathway design, endpoints, and the regulatory precedents that de-risk or sink an asset.
Domain expertise
biotech