VP Regulatory

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Lindus

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

☁️ SaaS

💰 Grant - Lindus on 2025-04

Healthcare • Biotechnology • SaaS

Lindus is a next-generation contract research organization (CRO) that combines integrated clinical trial delivery with an AI-assisted trial operating system. They offer end-to-end trial services—including patient identification and enrollment, flexible site models, decentralized trial capabilities, and integrated services—under a milestone- and performance-based commercial model that ties payments to timelines and operational performance. Lindus emphasizes real-time visibility, a single accountable team for study design through database lock, and expertise across cardiometabolic, respiratory, psychiatry, women’s health, dermatology, and diagnostics. The company operates across the US, UK, and Europe with APAC partnerships and reports over 160 full-time staff and high enrollment performance (82% of Lindus trials completed enrollment on or ahead of proposed timelines in the past three years).

📋 Description

• 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.

🎯 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