Vice President of CMC

Lindus

26d•Remote

About The Position

Our mission is to fix the broken clinical-stage biopharma model by in-licensing clinical-stage therapeutic assets and developing them through Lindus Health’s integrated, technology-first clinical trial infrastructure. We are building the next generation of biopharma. 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. 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.

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.
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.
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.
Experience at Phase I and II stages.
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.
Comfortable operating without a direct-report team, managing scope and delivery entirely through external consultants, CDMOs, and KOLs.
High agency and a bias for action.
Passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed.
Want to learn what life is like at a high-growth, mission-driven, VC-funded startup.

Nice To Haves

Experience selecting and contracting new CDMOs, not just managing inherited ones.
Tech transfer experience moving manufacturing from a non-US to a US manufacturer is particularly valuable.
Deep process-validation and commercial-launch experience is welcome but not required.
Late-stage/commercial experience is less prioritized than Phase I and II experience.

Responsibilities

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.
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.

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
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
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