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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 transformation into a fully integrated oncology company well underway, top-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 – forour 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-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-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
Ideal Candidate Profile >>> Late Phase Clinical Supply Knowledge
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge
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
Experience:
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
Attributes:
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
The base pay range for this position is expected to be $205,000 - $235,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.