Director, Clinical Supply Chain

Olema Oncology•San Francisco, CA

5d•$205,000 - $235,000•Hybrid

About The Position

Olema Oncology is seeking a Director, Clinical Supply Chain to oversee all aspects of the clinical supply chain, ensuring uninterrupted and timely drug supply for a major late-phase clinical program. This role requires close collaboration with various internal departments (Clinical Operations, CMC/Technical Operations, Quality, Regulatory) and external vendors to support study execution and ensure supply readiness as programs advance towards registration and commercialization. The position is based in San Francisco or Cambridge and requires occasional travel. The role is hands-on and demands an independent self-starter with extensive experience in end-to-end clinical supply chain management.

Requirements

Bachelor's degree in a scientific, engineering, supply chain, operations, or related discipline required; advanced degree preferred.
Late phase clinical development and global clinical supply chain management experience is required.
Deep understanding of end-to-end clinical supply chain management and global clinical trial execution.
Strong knowledge of GMP requirements and applicable global regulations governing clinical supplies.
Strong understanding of clinical development, including late-stage and registrational studies.
Knowledge of clinical supply systems and processes, including IRT/RTSM, QMS, inventory management, forecasting, and planning tools.
Minimum of 15+ years of biotechnology/pharmaceutical industry experience, with 8+ years in clinical supply chain management.
Oncology clinical trial experience strongly preferred.
Demonstrated experience leading end-to-end clinical supply strategy for global, complex clinical programs.
Experience managing comparator and/or standard-of-care drug supply.
Experience supporting clinical programs approaching NDA/marketing applications and commercial readiness is strongly preferred.
Extensive experience managing forecast demands and inventories.
Strong experience in clinical label development, global shipping, and customs.
Excellent project management skills.
5+ years of people management experience.
Demonstrated successful partnerships with the Clinical Operations team to deliver in the late phase of drug development.
Strategic thinker with the ability to remain hands-on and execute in a growing organization.
Strong leadership, influencing, and decision-making skills.
Excellent project management, planning, and organizational capabilities.
Proactive approach to identifying risks and developing solutions before impacting clinical programs.
Strong communication and cross-functional collaboration skills.
Comfortable operating with ambiguity and adapting quickly as program priorities evolve.
High degree of ownership, accountability, and attention to detail.
Ability to balance speed, quality, cost, and risk while maintaining a strong focus on patients and clinical program needs.

Nice To Haves

Advanced degree preferred.

Responsibilities

Lead end-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 on supply assumptions, risks, timelines, and decisions.
Work collaboratively with CMC, Clinical Operation, Quality Assurance, Regulatory, Finance and Legal.
Partner with Quality on deviations, investigations, root-cause analyses, CAPAs, vendor qualifications, and clinical supply–related procedures.
Proactively identify, assess, and mitigate clinical supply risks; develop contingency plans and drive timely cross-functional decisions and escalation when program milestones or patient supply may be affected.
Lead clinical supply readiness activities supporting NDA submissions, regulatory approval, and transition toward commercial supply, as applicable.
Ensure clinical supply activities and documentation remain compliant and inspection-ready in accordance with applicable GMP, GCP, GDP, regulatory, quality, and company requirements.
Develop and manage clinical supply budgets, forecasts, and vendor spend while balancing supply assurance, inventory exposure, timelines, and cost.
Stay current with state-of-the art approaches and applicable global regulations and industry standards.