Associate Director, Clinical Supply Chain
$185kOlema Oncology
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 – for our patients, for your career, and for what’s beyond. About the Role >>> Associate Director, Clinical Supply Chain As the Associate Director of Clinical Supply Chain reporting to the Vice President, Clinical Supply Chain, you will plan, create, implement, build, and optimize the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Olema’s clinical programs. This role is available in either our San Francisco or Cambridge office and will require about 15% domestic or international travel. Your work will primarily encompass:
- End to End clinical supply chain management
- Develop and implement global Clinical Supply Chain strategies
- Manage global inventories, shipping, and third-party manufacturers
- Develop and manage Interactive Response Technologies (IRT) systems
- Oversight packaging, labeling, and distribution activities at multiple
- Generate and manage clinical labels
- Identify supply chain risks, escalate if needed, and close out risk items
- Partner with Clinical Operations to align on assumptions and build clinical
- Bachelor's degree is required, Master’s degree is preferred
- Late phase clinical development and clinical supply chain management
- Thorough knowledge of Good Manufacturing Practices (GMP)
- Inventory management and third-party logistics oversight experience
- Extensive experience managing forecast demands
- Prior experience managing global, large, late-stage studies with standard of
- Strong global shipping and customs experience
- Solid experience developing clinical labels
- Experience developing IRT specifications
- Hands-on experience and troubleshooting proficiency with QMS
- Prior experience in oncology trials using small molecules is preferred
- Excellent project management skills
- Excellent verbal and written communication and skills
- Analytical thinking with problem-solving skills and the ability to adapt to
- A commitment to excellence
- Self-motivated and enthusiastic; fast learner who can identify the core
- Be a “difference maker” in terms of one’s professionalism and contributions
- Have impeccable professional ethics, integrity and judgment
- Be collegial, hard-working, confident, a self-starter and have a passion for
#LI-CK1
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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com- our careers page is olema.com/careers
- our LinkedIn page
$184.87k - $324.19k
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