Director, Clinical Supply Chain

olema

Boston (MA)

On-site

USD 180,000 - 240,000

Full time

8 days ago
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Job summary

Olema Oncology is seeking a Director of Clinical Supply Chain to oversee end-to-end supply for late-stage programs, partnering with Clinical Operations, CMC/Technical Operations, Quality, and external vendors. This hands-on role will reside in SF or Cambridge, with travel as needed.

You will lead global strategies, demand forecasting, inventory and distribution, and IRT/RTSM supply planning to support clinical trials through potential registration and commercialization.

Qualifications

  • Experience leading clinical supply chains from development to late-stage trials.
  • Strong collaboration with Clinical Operations, QA, Regulatory, and vendors.
  • Ability to design and execute global supply strategies across all development phases.

Responsibilities

  • Lead end-to-end clinical supply chain strategy for a global late-stage program.
  • Provide functional leadership across planning, manufacturing alignment, and CDMO oversight.
  • Develop and maintain demand forecasts and supply plans aligned with enrollment and timelines.
  • Oversee inventory, distribution, depot strategy, imports/exports, and third-party partners.
  • Lead contingency planning for enrollment variances, manufacturing delays, and supply risks.
  • Manage packaging, labeling, distribution, and study closeout activities.

Skills

Clinical supply chain
End-to-end management
Global logistics
CDMOs oversight
Cross-functional leadership
Forecasting

Education

Bachelor's degree
Advanced degree in related field

Job description

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It's an exciting time to be part of Team Olema , with our transfor mation into a fully integrated oncology company well underway , t op-line data from our lead program expected later this year , and our first potential commercial launch on the horizon.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape - particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

If you're ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together - for our patients, for your career, and for what's beyond .

About the Role >>> Director, Clinical Supply Chain

As a Director, Clinical Supply Chain reporting to the Vice President Clinical Supply Chain, you will have oversight of all aspects of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for one of Olema's largest, late phase clinical programs. This highly cross-functional role will partner closely with Clinical Operations, CMC/Technical Operations, Quality, Regulatory, and external vendors to support study execution and ensure clinical supply readiness as programs advance toward registration and commercialization.

This hands-on role requires an independent self-starter with extensive experience in end-to‑to‑end clinical supply chain management.

The role will be based out of either our San Francisco or our Cambridge office and require occasional travel .

Your work will primarily encompass:

  • Lead end-to‑to‑end clinical supply chain strategy and execution for a global, late-stage clinical program
  • Provide technical, functional, and program leadership across clinical supply planning and execution, including alignment with manufacturing and release schedules and direct oversight of CDMOs and other external partners
  • Develop and implement global Clinical Supply Chain strategies and deliver clinical supplies for all phases of clinical development
  • Develop and maintain demand forecasts and executable supply plans based on enrollment assumptions, country and site activation timelines, dosing requirements, manufacturing schedules, and evolving study scenarios
  • Manage global inventory and distribution strategies, including depot management, import/export and customs requirements, storage and handling, and oversight of third‑party manufacturers and logistics providers
  • Lead scenario planning and contingency strategies addressing enrollment variability, manufacturing delays, comparator availability, expiry and shelf‑life constraints, and potential distribution disruptions
  • Oversee packaging, labeling, distribution, depot strategy, product accountability, returns, reconciliation, destruction, and clinical supply study‑closeout activities
  • Lead IRT/RTSM supply strategy, design, setup, testing/UAT, implementation, change control, and ongoing performance, including inventory and resupply requirements
  • Represent Clinical Supply Chain on cross‑functional study and program teams, providing strategic guidance
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