Associate Director/Director, Clinical Drug Supply

Climb Bio•Newton, MA

13d•$178,000 - $260,000•Onsite

About The Position

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy and CLYM116, an anti-APRIL monoclonal antibody in development for IgA nephropathy. At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate. They reflect our commitment to patients, each other, and the pursuit of transformative science. We are seeking a highly motivated Associate Director/Director, Clinical Drug Supply. Reporting to the SVP of Technical Operations, this is a critical role in establishing clinical supply as a function at Climb Bio, with ownership of the partner network, forecasting standards, and supply strategy that will carry our programs from Phase 3 readiness through BLA submission.

Requirements

Bachelor’s degree in a scientific, engineering, or supply chain discipline; equivalent relevant experience will be considered.
Associate Director level candidates will have at least 8 years of clinical supply chain experience in the biopharmaceutical industry and Director level candidates at least 10 years, including accountability for clinical drug supply on at least one Phase 3 program.
Demonstrated experience selecting and managing clinical labeling, packaging, and distribution partners and IRT systems, including requirements definition, contracting, and performance oversight.
Demonstrated ownership of clinical supply forecasting, inventory, and resupply across multiple concurrent studies, with working knowledge of GMP and GCP requirements for investigational product.
Exceptional problem-solving and communication skills, and the ability to operate in a collaborative and fast-paced environment.

Nice To Haves

Advanced degree in a scientific, engineering, or supply chain discipline.
Experience building a clinical supply function, or standing up forecasting and vendor oversight processes, at a small or emerging biopharmaceutical company.
Experience with cold-chain biologics and injectable presentations.
Contribution to BLA or MAA submissions, or to health authority inspection readiness, for clinical supply or labeling content.
Experience with global distribution, import and export requirements, and QP release for ex-US studies.
Familiarity with comparator and ancillary supply sourcing.

Responsibilities

Own clinical drug supply across Climb Bio’s portfolio, from supply forecasting and packaging through distribution, resupply, and study close-out.
Lead the selection and onboarding of Climb Bio’s Phase 3 label, packaging, and distribution partner and the supporting IRT system, including requirements definition, evaluation, contracting, and implementation.
Establish the clinical supply function at Climb Bio, defining the forecasting models, inventory and expiry standards, vendor oversight practices, and documentation applied consistently across all trials.
Develop the long-term clinical supply strategy across the potential Phase 3 studies, aligning drug product availability, packaging configurations, labeling, and distribution design with BLA readiness.
Partner with Clinical Operations on study startup, country and site activation, and enrollment-driven resupply so that supply plans support enrollment commitments and protocol requirements.
Direct close-out of ongoing Phase 1 and Phase 2 studies, including investigational product reconciliation, returns and destruction, and documentation that holds up to inspection.
Own clinical supply budgets and vendor performance, and drive resolution of supply-related quality events, temperature excursions, and change controls with Quality and Technical Operations.
Represent clinical supply on cross-functional program teams and in regulatory submissions and health authority interactions, including labeling and supply-related sections and queries.