Vice President – CMC

Job not on LinkedIn

🔥 33 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Own CMC oversight across every active asset: drug substance and drug product, analytics, stability, comparability, supply, quality, GMP ownership, QP release, and the CMC sections of regulatory filings. Keep every program on time and on budget, and feed CMC realities into clinical development planning. • Select, contract, and manage CDMOs, testing labs, and other suppliers, holding them to timelines, quality, and cost. This is a core part of the role, not a secondary responsibility. • Scope and de-risk the CMC of inherited and in-licensing candidate assets, flagging manufacturing complexity or cost that could make an otherwise attractive asset uneconomic, and identifying where formulation choices create protectable IP value. • Build and manage a network of CMC KOLs and consultants, and support regulatory and clinical colleagues on CMC content for FDA and other agency interactions.

🎯 Requirements

• 10+ years in CMC or pharmaceutical development, with at least the last 3-4 in a role owning CMC for one or more programs - we care more about the substance of what you've owned than the exact title. • Personally managed 3+ CDMOs or external manufacturing partners through clinical development-stage work, including tech transfer, scale-up, and supply of drug substance and drug product for clinical trials. Experience selecting and contracting new CDMOs, not just managing inherited ones, is a strong plus. Tech transfer experience moving manufacturing from a non-US to a US manufacturer is particularly valuable given our portfolio. • Owned the CMC content of regulatory submissions: authored or led the CMC sections (Module 3) for multiple INDs, and ideally contributed to at least one NDA/BLA or major amendment. Given our exit-before-commercialization model, deep process-validation and commercial-launch experience is welcome but not required. • Most of our current portfolio sits at Phase I and II, so experience at these stages is prioritised over late-stage/commercial experience. • CMC experience across more than one modality (small molecule and biologics both preferred, covering both drug substance and drug product), or a clear track record of getting up to speed on a new modality quickly with expert support. • Experience picking up assets from third parties and quickly diagnosing the state, gaps, and risks of an inherited CMC package. • Sound judgment on what "good enough" CMC looks like at each stage, so effort matches the value-inflection point rather than a commercial launch we won't run ourselves. • Comfortable operating without a direct-report team, managing scope and delivery entirely through external consultants, CDMOs, and KOLs. • 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

🏖️ Benefits

• 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