VP Regulatory

**🍊Our mission** Great science regularly stalls in the clinic, not because the science is wrong, but because the company behind it lacks the capital, infrastructure, or focus to take it all the way through. Today’s clinical-stage biopharma model is broken, and as a result promising treatments never reach patients. Our mission is to fix this: we’re building the next generation of biopharma by in-licensing clinical-stage therapeutic assets and developing them through Lindus Health’s integrated, technology-first clinical trial infrastructure. We’re a new initiative, but we’re building on a proven foundation - the same infrastructure that has delivered 82% of Lindus Health’s sponsor trials on or ahead of timeline, across 40+ completed trials across the US and Europe. 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. ## **🍊 About the role** 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. ## **🍊 About you** ### **We'd like to hear from you if…** - You have high agency and a bias for action - You are passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed - You want to learn what life is like at a high-growth, mission-driven, VC-funded startup You belong here! If your experience and interests match with some of the below, we want you to apply - 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. We care more about the substance of what you've led than the exact title. - 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. Experience with breakthrough, fast track, or orphan designation requests, and with EMA scientific advice, is a plus. - 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). Post-approval or label-negotiation experience is welcome but not required given our exit-before-commercialization model. - 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. Comfort orchestrating external experts for the specialist 20% rather than needing to be the specialist on every question. - 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. ## **🍊What you'll focus on** - **Focus area 1: Regulatory Strategy & Pathway Ownership** - 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. - **Focus area 2: Direct Agency Engagement** - 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. - **Focus area 3: External Expert Network & Cross-Functional Coordination** - 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. - **Focus area 4: Diligence & Exit Readiness** - 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. ## **🍊 What we offer (UK)** Make an impact across all areas of our business and fix one of the world's most broken industries. - Competitive salary, plus meaningful stock options - Flexible working: We have an incredible office near London Bridge and encourage people to work 3 days per week from the office - 30 days annual leave in addition to Bank Holidays - £60 monthly wellness allowance, which you can spend on our company health insurance scheme through AXA, a wellhub membership, or wellness activities and expenses of your choice! - 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 to put towards courses, certifications, and development - 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 - Charity events and fundraising opportunities through our charity partnership with the Forward Trust ## **🍊 What we offer (US)** Make an impact across all areas of our business and fix one of the world's most broken industries. - Competitive salary, plus meaningful stock options - 27 days annual leave in addition to 11 National Holidays - Health insurance coverage through our PEO Trinet - $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice! - Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver - $2,000 Learning and Development allowance each year to put towards courses, certifications, and development - Regular whole company and team events, both in person and virtually - Access to gym and retail discounts through our benefits platform Happl - Monthly lunch voucher for our remote teams - Charity events and fundraising opportunities through our charity partnership with the Forward Trust ## **🍊 Our hiring process** - Initial conversation with Sophie, Head of Talent (45 minutes) - Second interview with our Chief Development Officer, or the interim hiring lead, Meri our CEO (30 minutes) - Technical/regulatory interview with a member of our Development team (60 minutes) - Meet our Chief Medical Officer, Luke (30 minutes) - Values interview with 2 team members (30 minutes) - Referencing We try to arrange for at least one interview to be in-person so you can see our office and meet more of the team. **We will only contact you from** [****](http://lindushealth.com) **email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email.** We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status