About this opportunity
Olema Oncology lists this Senior Manager, Clinical Supply Integration opportunity in san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Manager, Clinical Supply Integration
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.
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 Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. 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 could transform the metastatic breast cancer treatment paradigm and provide access to 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 presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year.
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.
About the Role >>> Senior Manager, Clinical Supply Integration
As the Senior Manager, Clinical Supply Integration reporting to the Vice President, Clinical Supply Chain, you will 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. Serving as the central point of coordination across external providers and internal study teams, you will ensure plans are executable, lead times and dependencies are visible, risks are identified and addressed early, and medicines reach patients safely and on time. In addition you will partner closely with Clinical Operations, CMC, Quality, Regulatory, Finance, and external vendors to support global clinical programs as Olema continues to advance its pipeline.
This role is based out of our San Francisco or Boston office and will require 10-15% domestic or international travel.
Your work will primarily encompass:
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
Ideal Candidate Profile >>>
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 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
Experience:
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
Attributes:
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 escalation 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
The base pay range for this position is expected to be$150,000 - $160,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.