Program Manager, CMC

Olema Oncology • San Francisco, CA

23h • $150,000 - $170,000

About The Position

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.

Requirements

• 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.
• 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).
• Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies.
• Collaborating and interacting with external vendors/CDMOs.
• Experience preparing materials for team or leadership meetings.
• Highly organized with strong attention to detail and follow-through.
• Energetic, proactive, and action-oriented — a true “go-getter.”
• Friendly and approachable with a collaborative mindset.
• Strong communicator who can tailor messaging to diverse audiences.
• Skilled at bridging functions and building strong working relationships.
• Comfortable navigating a fast-paced, evolving environment.
• Solutions-oriented with sound judgment and appropriate escalation.
• Strong team player who thrives in highly collaborative settings.

Nice To Haves

• Familiarity with regulatory submission timelines and CMC documentation requirements preferred.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager