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Program Manager, CMC at Olema Oncology | Boston, MA

Olema OncologyBoston, Massachusetts
Hybrid Full-time $150K/yr - $170K/yr

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Experience Level

Manager

Qualifications

Proven experience in CMC project management within the biopharmaceutical industry. Strong understanding of regulatory requirements and quality assurance processes. Excellent communication and leadership skills for cross-functional collaboration. Ability to manage multiple projects and priorities simultaneously. Proficiency in project management tools such as Smartsheet.

About the job

At Olema Oncology, our mission is to revolutionize the landscape of breast cancer treatment and beyond. We are at the forefront of drug development with our lead candidate, palazestrant (OP-1250), a complete estrogen receptor antagonist (CERAN) currently being developed for metastatic breast cancer. This innovative therapy has the potential to become a blockbuster, both as a standalone treatment and in combination with other therapies for ER+/HER2- metastatic breast cancer. Additionally, we are developing OP-3136, a powerful KAT6 inhibitor that showcases best-in-class potential.

Our progress is fueled by a culture of fearless support, motivation, and collaboration. At Olema, we prioritize our people, ensuring that our efforts lead to groundbreaking advancements in patient care. If you are eager to be part of a transformative journey that impacts patients, propels your career, and expands the horizons of oncology, we welcome you to join our dynamic team.

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About the Role: Program Manager, CMC

As the Program Manager, CMC, you will report to the Director of CMC Program Management and be pivotal in leading integrated CMC program planning and execution throughout clinical development stages. Your role will be to convert CMC strategies into actionable, cohesive plans that facilitate timely clinical and regulatory advancements. This position demands extensive cross-functional collaboration with teams from Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance, and external partners. You will be recognized as an operational leader, responsible for driving accountability, fostering alignment, managing risks, and guiding teams through challenges effectively.

This position may be located in either our San Francisco, CA or Boston, MA offices, with a requirement for 10% travel.

Your primary responsibilities will include:

  • Leading integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), collaborating with Director- and Senior Director-level leaders to define deliverables, timelines, and priorities that align with clinical and regulatory objectives.
  • Developing and maintaining integrated project timelines using Smartsheet or similar tools to ensure project milestones are met efficiently.

About Olema Oncology

Olema Oncology is committed to advancing innovative therapies for breast cancer and expanding treatment options for patients. Our dynamic team is driven by a commitment to excellence and a passion for making a difference in the lives of patients through groundbreaking research and development.

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