Vice President of CMC

**🍊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 CMC to own Chemistry, Manufacturing and Controls across our entire in-licensed portfolio, and help us prove out a leaner, faster way to take promising assets to their next value-inflection point. This role is important because every asset we in-license inherits a CMC package of varying maturity, and CMC delays are one of the fastest ways for a promising asset to stall before it reaches its next milestone. The right hire keeps every program's CMC on time and on budget, feeds manufacturing reality into how we plan trials, and helps us pick the right assets to license in the first place. You'll work closely with the Chief Development Officer, our clinical and regulatory colleagues, and a network of external CDMOs, testing labs, and CMC consultants and KOLs that you'll build and manage yourself. **How we're open to structuring this role** We know exceptional CMC leaders sit in different places right now, so we're flexible on how this role is engaged: - **Full-time permanent**, or **contract/fractional** - including candidates who can only offer part of their week - If contracting, a **minimum of 2 days/week** on an ongoing basis, ebbing and flowing heavily around key submissions and deliverables (e.g. IND filings, study protocols) - For contract arrangements, we have a preference for a **W2 agreement** over 1099, so we can secure dedicated, reserved time each week - Whatever the structure, speed and quality under tight, submission-driven timelines are non-negotiable for this role This is a fully remote US or UK-based role. **About you** **We'd like to hear from you if…** You belong here! If your experience and interests match with some of the below, we want you to apply: - 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 **What you'll focus on** - **Focus area 1: CMC Ownership & Program Delivery** - 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. - **Focus area 2: Supplier & CDMO Management** - 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. - **Focus area 3: Diligence & Asset Selection** - 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. - **Focus area 4: Expert Network & Regulatory Support** - 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. **What we offer** 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 Talent (45 minutes) - Second interview with our CEO (30 minutes) - Technical interview with a member of our Development team (60 minutes) - Values interview with 2 team members (30 minutes) - Referencing- for contract candidates, references can be taken earlier in the process **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