Next-gen CRO with accountability built in, engineered to give sponsors confidence & control over their clinical studies
VP Regulatory
Location
United States
Posted
7 days ago
Salary
0
Seniority
Lead
Job Description
VP Regulatory
Lindus
• 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.
Job 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. 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.
- 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.
Benefits
- 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
- Health insurance coverage through our PEO Trinet
- 27 days annual leave in addition to 11 National Holidays
- $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice!
- $2,000 Learning and Development allowance each year to put towards courses, certifications, and development
- Monthly lunch voucher for our remote teams
- Charity events and fundraising opportunities through our charity partnership with the Forward Trust
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