Associate Director, Clinical Supply Chain

Associate Director, Clinical Supply Chain

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 / logistics providers
• Develop and manage Interactive Response Technologies (IRT) systems
• Oversight packaging, labeling, and distribution activities at multiple vendors
• 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 supply to meet program demand
• Represent Clinical Supply Chain on study execution teams

Knowledge:

• 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)

Experience:

• 8+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management
• Inventory management and third-party logistics oversight experience
• Extensive experience managing forecast demands
• Prior experience managing global, large, late-stage studies with standard of care drugs
• Strong global shipping and customs experience
• Solid experience developing clinical labels
• Experience developing IRT specifications
• Hands-on experience and troubleshooting proficiency with QMS and purchasing systems
• Prior experience in oncology trials using small molecules is preferred
• Excellent project management skills

Attributes:

• Excellent verbal and written communication and skills
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• A commitment to excellence
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Entrepreneurial mindset and the ability to prioritize key work streams and requirements that will change over the near and mid-term
• A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required
• 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 results

The base pay range for this position is expected to be $185,000 - $200,000 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.