Program Manager, CMC

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.  

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. 

You can view our latest corporate deck and other presentations here.

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader – driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel. 

Your work will primarily encompass:

• Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
• Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
• Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
• Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
• Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
• Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
• Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
• Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
• Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
• Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

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 required, Life Sciences or related disciplines preferred. 
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
• Knowledge of CMC development processes across clinical stages. 
• Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

• Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
• Experience driving CMC execution in early clinical-stage development (Phase 1–2), with exposure to Phase 3 readiness considered a plus. 
• Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain).