Oversee the end-to-end flow of investigational medicinal products as a Senior Manager at Olema Oncology.
Posted by employer 3 days ago
First seen on Joblaze 2 days ago
Last verified on the company career page 17 hours ago
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Not disclosed in this posting: visa sponsorship.
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The Senior Manager of Clinical Supply Integration at Olema Oncology is responsible for overseeing the comprehensive logistics of investigational medicinal products, ensuring they are delivered safely and on time to clinical trial sites. This role requires a strong background in global clinical supply operations, project management, and regulatory compliance, with a focus on collaboration across various internal and external teams. Ideal candidates will have significant experience in the biotechnology or pharmaceutical sectors, particularly in managing complex clinical studies. Olema's commitment to transforming cancer treatment underscores the importance of this role within a dynamic and gro
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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:
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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 and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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