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Salary: USD 150,000 - 160,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing transformative therapies for breast cancer and beyond. The company's lead candidate, palazestrant, is a novel estrogen receptor antagonist currently in two pivotal Phase 3 trials, with top-line data expected in Q1 2027 and potential commercial launch in 2028. A follow-on candidate, OP-3136, is a KAT6 inhibitor in development for metastatic breast cancer and prostate cancer.
As Senior Manager, Clinical Supply Integration, you will report to the Vice President of Clinical Supply Chain and oversee the end-to-end flow of investigational medicinal products (IMPs) from manufacturing through packaging, labeling, quality-person (QP) release, logistics, clinical depots, and trial sites. You will serve as the central coordination point across external contract development and manufacturing organizations (CDMOs) and internal study teams, ensuring plans are executable, lead times and dependencies are visible, risks are identified early, and medicines reach patients safely and on time.
Key responsibilities include:
- 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, labeling, procurement, and manufacturing runs, aligning activities across Clinical Supply, Clinical Operations, Quality, Regulatory, and CMC teams
- Partner with internal supply chain teams and external vendors to ensure timely execution and appropriate escalation of issues
- Maintain supply timelines for all clinical programs, including supply protocols, procedures, systems, and documentation management
- Support departmental budgets with the VP of Supply Chain and Finance, 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
The role is based in San Francisco or Boston and requires 10–15% domestic or international travel.
REQUIREMENTS:
Education & Knowledge:
- Bachelor's degree required; Master's degree preferred
- Strong understanding of end-to-end global clinical supply operations
- Working knowledge of GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), Quality, Clinical Operations, and regulatory requirements
- Familiarity with clinical supply, QMS (Quality Management Systems), planning, project management, and data/reporting systems
Experience:
- Minimum 8+ years of progressive clinical supply experience with a Bachelor's degree, or 6+ years with a Master's degree, within 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, labeling, and 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
Attributes:
- Clear, concise communicator who can influence without direct authority
- Strong analytical judgment, problem-solving, and risk-management skills, with 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