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About the Role
Oversee the end-to-end flow of investigational medicinal products (IMPs), from manufacturing through packaging and labeling, QP release, logistics, clinical depots, and trial sites. Serve as the central point of coordination across external providers and internal study teams, ensuring plans are executable, lead times and dependencies are visible, risks are identified and addressed early, and medicines reach patients safely and on time. Partner closely with Clinical Operations, CMC, Quality, Regulatory, Finance, and external vendors to support global clinical programs as Olema continues to advance its pipeline.
Responsibilities
- Lead coordination of clinical supply activities across global CDMOs in the US, EU, UK, APAC, and LATAM, managing multiple timelines, dependencies and linked deliverables
- Oversee project logistics for packaging and labeling, procurement, and manufacturing runs, aligning activities across Clinical Supply, Clinical Operations, Quality, Regulatory, and CMC
- Partner with internal supply chain team and external vendors to ensure timely execution and appropriate identification and escalation of issues
- Maintain supply timelines for all clinical programs, including supply protocols, procedures, systems and documentation management
- Partner with the Vice President, Supply Chain and Finance to support and manage departmental budgets, monitor project progress, and ensure packaging, labeling, and global distribution are properly planned and executed
- Identify operational gaps and drive cross-functional continuous improvement initiatives, implementing SOPs, lessons learned, and best practices to strengthen and scale clinical supply operations as the portfolio grows
Requirements
- Bachelor's degree is required; master's degree is preferred
- Strong understanding of end-to-end global clinical supply operations
- Working knowledge of GMP, GDP, Quality, Clinical Operations, and regulatory requirements
- Familiarity with clinical supply, QMS, planning, project management, and data/reporting systems
- Minimum of 8+ years of progressive clinical supply experience with a Bachelor’s degree, or 6+ years with a Master’s degree, within the biotechnology or pharmaceutical industry
- Experience supporting complex global and/or late-stage studies preferred
- Demonstrated experience coordinating end-to-end clinical supply activities across manufacturing, packaging and labeling, release
- Previous exposure to inventory, demand, expiry, logistics, and distribution preferred
- Strong project management and data reconciliation skills, with demonstrated ability to investigate discrepancies and drive issues through resolution
- Strong vendor management and governance experience, including performance monitoring, issue escalation, and resolution
- Oncology clinical trial experience preferred
- Clear, concise communicator who can influence without direct authority
- Strong analytical judgment, problem-solving, and risk-management skills, with the ability to identify issues early and escalate appropriately
- Highly organized and capable of managing multiple complex timelines, priorities, and dependencies simultaneously
- Strong sense of ownership and accountability, with consistent follow-through from planning through execution
- Collaborative and effective at building productive relationships across internal teams and external partners
- Hands-on and operationally minded, proactive, pragmatic, and committed to continuous improvement and operational excellence
- Strong commitment to patients, teamwork, quality, and results
Skills
- Clinical Supply Integration
- GMP
- GDP
- Quality
- Clinical Operations
- Regulatory requirements
- QMS
- Planning
- Project Management
- Data/Reporting Systems
- Inventory Management
- Demand Forecasting
- Expiry Management
- Logistics
- Distribution
- Data Reconciliation
- Vendor Management
- Risk Management
- Communication
- Problem-Solving
Location
- San Francisco
- Boston
Work Type
- Onsite
- Domestic travel
- International travel
Experience Level
- Senior Manager
- 8+ years of progressive clinical supply experience with a Bachelor’s degree
- 6+ years with a Master’s degree
Education Level
- Bachelor's degree
- Master's degree preferred
Salary/Compensations
- $150,000 - $160,000 annually
Benefits
- Equity
- Bonus
- Competitive compensation and benefits package
- Open, flexible, and friendly work environment
- Platform to develop long-term careers
About the Company
- 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.
- With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema.
- Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer.
- Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution.
- We are a small group of nimble self-starters who bring consistency in our 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.
Equal Opportunity
- 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.