Director, Clinical Supply Chain in Waltham, Massachusetts at Crescent Biopharma

We are seeking a Director, Clinical Supply Chain to own clinical supply chain as we advance pa multi-program portfolio from Phase 1 to Phase 3. You will ensure clinical supplies gets from manufacturing to sites and patients without interruption, this includes forecasting demand, managing CDMOs and depots, overseeing packaging and labeling, and building the processes that don't exist yet because we haven't needed them at this scale until now. You must be comfortable owning an end-to-end function and completely build from the ground up.

• Own clinical supply strategy for one of our programs from early Phase 1 work through pivotal trials, including the IMP and Standard of Care, when needed.
• Build demand forecasts and supply plans alongside CMC and Clinical Ops, working through the added complexity of combination regimens and trials that span the US, EU, and Greater China.
• Run point on IRT/IWRS systems — vendor selection, system setup, UAT, and the changes that inevitably come up mid-trial.
• Oversee packaging, labeling, and distribution, keeping us compliant with GMP, GCP, and import/export rules that vary by country.
• Manage our CDMO, depot, and logistics partners directly, including contract terms and holding them accountable when something's off.
• Work closely with Regulatory and Quality so supply plans hold up against current expectations in every country we're trialing in.
• Think ahead on risk — expiry timelines, retest strategy, what happens if a shipment gets held up or a comparator becomes hard to source.
• Put real processes and SOPs in place for a function that's still being built, with an eye toward what we'll need as the pipeline grows.
• Own the clinical supply budget and vendor spend, and weigh in on timelines and risk with the broader program teams.
• Be the supply chain voice in cross-functional program meetings and keep leadership in the loop on anything that could affect timelines and costs.
• There is an expectation that this role will mentor junior team members as the team need to grow.

• B.S and M.S. in Business, Supply Chain or Engineering
• 10+ years in clinical supply chain at a biotech, pharma company, or CDMO/CRO working sponsor programs.
• Real experience running clinical supply for biologics. ADC or combination-product experience is a strong plus.
• Background with global, multi-region trials, including the cold chain and handling requirements that come with biologics and ADCs.
• Comfort working hands-on in IRT/IWRS platforms and forecasting tools.
• Solid working knowledge of GMP, GCP, and the import/export rules that govern investigational product across borders.
• A track record of building processes from scratch, not just operating within a function someone else already set up, is a strong plus.
• Confidence negotiating with and managing vendors, you will own those relationships directly, not only monitor them.
• A genuine collaborator — this role touches CMC, Clinical Ops, Regulatory, and Quality constantly, and none of it works if you operate in a silo.

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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