VP Regulatory

Lindus

2d•Hybrid

About The Position

Our mission is to fix the broken clinical-stage biopharma model by in-licensing clinical-stage therapeutic assets and developing them through Lindus Health’s integrated, technology-first clinical trial infrastructure. We are building the next generation of biopharma. We're in-licensing 5-7 clinical-stage, typically Phase-2-ready assets, funded directly from Lindus Health’s balance sheet. We’re targeting deal close on our first assets through 2026, with first trials launching in H1 2027. We're looking for an exceptional VP of Regulatory Strategy to own the regulatory pathway for every asset in our portfolio, and be the person in the room with the FDA who protects our timelines and credibility. This role is important because our whole model depends on moving in-licensed assets to their next value-inflection point fast, and the biggest risk to that speed is getting the regulatory pathway, endpoints, or agency interactions wrong. The right hire de-risks that at every stage, from diligence through to exit. You'll work closely with the Chief Development Officer (interim: CEO / Head of Development while that search closes), the wider executive team, and a network of external regulatory experts and KOLs that you'll build and manage yourself.

Requirements

15+ years in regulatory affairs in biopharma, with at least the last 5 in a senior strategy-owning role such as Senior Director, VP, Head of Regulatory Affairs, or Global Regulatory Lead, ideally at a company with a broad portfolio.
Personally led at least 5+ FDA interactions, including pre-IND, End-of-Phase 2, and Type B/C meetings, as the company's lead voice in the room rather than in a support capacity.
Hands-on ownership of major submissions across the development lifecycle: multiple INDs filed and maintained, and involvement in at least one NDA or BLA (as lead or a core contributor).
Strategy set for programs across more than one therapeutic area and modality (small molecule and biologic exposure preferred), or a clear track record of getting up to speed on new areas quickly with KOL support.
Time spent in a small, lean, or virtual biotech, ideally including asset in-licensing or acquisition diligence.
Strong grasp of pathway design, endpoints, and the regulatory precedents that de-risk or sink an asset, and the ability to translate that into clear go/no-go input.

Nice To Haves

Experience with breakthrough, fast track, or orphan designation requests, and with EMA scientific advice.
Post-approval or label-negotiation experience.
Comfort orchestrating external experts for the specialist 20% rather than needing to be the specialist on every question.

Responsibilities

Set and own the regulatory strategy across the portfolio: pathway selection, endpoint and pivotal design implications, designations (breakthrough, orphan, fast track), and the regulatory shape of each program's value-inflection point.
Lead FDA interactions directly (Pre-IND, IND approval, End-of-Phase 2, Type B/C), as the Lindus person in the room, and support the CDO and executive team on the highest-stakes regulatory decisions.
Bring in and manage external regulatory experts and KOLs for specialist or region-specific questions, and work with CMC and clinical colleagues to keep filings and agency submissions coherent across functions.
Assess regulatory risk and pathway credibility during asset diligence, pressure-test clinical development plans against likely agency positions, and build the regulatory intelligence that informs exit conversations.

Benefits

Competitive salary, plus meaningful stock options
Flexible working
30 days annual leave in addition to Bank Holidays (UK)
£60 monthly wellness allowance (UK)
Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
£1,000 Learning and Development allowance each year (UK)
Regular whole company and team events, both in person and virtually
Access to gym and retail discounts through our benefits platform Happl
A well-stocked pantry and drinks fridge, Monday breakfast spread and catered team lunch on a Thursday for the UK office every week!
Cycle-to-work scheme and other salary sacrifice options available (UK)
Charity events and fundraising opportunities through our charity partnership with the Forward Trust
27 days annual leave in addition to 11 National Holidays (US)
Health insurance coverage through our PEO Trinet (US)
$40 monthly wellness allowance (US)
$2,000 Learning and Development allowance each year (US)
Monthly lunch voucher for our remote teams (US)