Vice President of Regulatory, Lindus
+ Stock options
Accountable research organization
Posted today
Accountable research organization
101-200 employees
Posted today
+ Stock options
101-200 employees
Company mission
To give sponsors confidence and control over their clinical studies.
Role
Who you are
- 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 the job involves
- 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
- 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
Application 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
Salary benchmarks
Our take
Traditional clinical research companies are often inefficient and rely upon pen and paper, even for the UK COVID-19 vaccine trial, one of the best-funded trials in history. In addition, the cost of conducting clinical trials has skyrocketed over the last decade. This, of course, stifles innovation and means fewer new treatments for patients.
In response to these challenges, Lindus Health was established with the mission to simplify patient participation in research and expedite the development of novel treatments. On a mission to change how trials are conducted in order to provide faster, safer clinical trials on behalf of companies developing new treatments, and lowering the barriers to participation for patients.
Since launching in 2021, Lindus Health has actively connected patients with clinical trials across diverse domains, encompassing areas such as type 2 diabetes, COVID-19 diagnostics, and mental health. Bolstered by several successful funding rounds, the company is poised to facilitate end-to-end clinical trials and research sponsors with high-quality data. Alongside this growth, Lindus is expanding its workforce. This strategic approach underscores its commitment to reshaping the landscape of clinical research for the betterment of patients and the advancement of medical science.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
66% female employees
Company
Funding (last 2 of 4 rounds)
Jan 2025
$55m
SERIES B
Aug 2023
$18m
SERIES A
Total funding: $78.7m
Company benefits
- 31 paid days off each year, including bank holidays. 🇬🇧
- £60 monthly wellness allowance with complete flexibility on how to spend this including opting in to a company private health insurance scheme through AXA, a wellhub membership and more! 🇬🇧
- Access to gym and retail discounts through our benefits platform Happl. 🇬🇧
- Enhanced Parental Leave - 16 weeks full pay for primary care giver & 6 weeks full pay for secondary care giver 🇬🇧
- Cycle to work and other salary sacrifice schemes 🇬🇧
- Regular whole company and team events, both in person and virtually! 🇬🇧
- £1,000 Learning and Development allowance each year to put towards courses, certifications and development 🇬🇧
- A well stocked pantry and drinks fridge, Monday breakfast spread and catered team lunch on a Thursday for the UK office every week! 🇬🇧
Company values
- Be transparent: We share information across the whole team, avoiding hierarchies and siloes. No politics!
- Stay curious: Deference to "the way it has always been done" is the biggest thing holding our industry back
- Be high-agency: Nothing happens unless we make it happen. We never assume something is somebody else's responsibility
- Act quickly: Once we’ve made a decision. We win by moving fast
- Benefit patients: Our mission is serious, but we’ll only achieve it if we have fun while we go. Innovation doesn’t take place in a boring environment
Company HQ
Downtown Crossing, Boston, MA
Articles
Leadership
Meri Beckwith
(Co-Founder & Co-CEO)Previously a venture capital investor and partner to biotech and digital health companies including Attest, Latent Logic, Helloself and CoMind.
Michael Young
(Co-Founder & Co-CEO)Previously a Special Adviser to the UK Prime Minister, where they advised the UK government on life sciences. Also a former Management Consultant at McKinsey and LEK.
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