Senior Director, Commercial Manufacturing and Operations

ABOUT THE ROLE 

The Senior Director, Commercial Manufacturing & Operations is Olema’s senior leader accountable for building, scaling and governing the commercial manufacturing and supply platform for palazestrant. The role owns end-to-end commercial supply, spanning drug substance (DS), drug product (DP), packaging, labeling, serialization, inventory and distribution, and ensures uninterrupted, cost-effective supply to Olema’s 3PL and specialty pharmacy network. The Senior Director will set the commercial supply strategy, liaison with executive leadership, and own and executes the planning, inventory, vendor and logistics work behind it, then build the team as the business grows. 

KEY RESPONSIBILITIES 

Commercial Supply Strategy & Launch Readiness 

• Set the commercial supply strategy for palazestrant, including network design, capacity and second-source planning, and the launch inventory build (including at-risk manufacturing and packaging decisions). 

• Own the commercial supply budget, COGS inputs, supply cost KPIs and tariff exposure in partnership with Finance. 

• Lead supply-side launch readiness from NDA submission through PDUFA and market entry; maintain the launch risk register and present status, risks and mitigation options to executive leadership. 

Manufacturing & CDMO Governance (DS & DP) 

• Provide business and operational oversight of commercial DS and DP manufacturing, partnering with CMC Technical, Quality and Regulatory on registrational readiness, PPQ, process validation and the transition to commercial supply. 

• Negotiate and own commercial supply agreements; run quarterly business reviews and performance metrics across DS, DP, packaging and logistics partners. 

• Manage CDMO production schedules day to day, resolving issues and escalating as needed to protect supply. 

Packaging, Labeling & Serialization 

• Oversee commercial packaging and labeling vendors, including artwork readiness, labeling specifications, and batch documentation. 

• Working with IT, ensure serialization, aggregation and traceability systems are validated, DSCSA-compliant and integrated with 3PL and specialty pharmacy partners. 

Supply Planning & Inventory 

• Run the monthly supply planning (S&OP) cycle, translating the commercial forecast into DS, DP and packaging plans and setting safety stock, coverage and replenishment policies. 

• Manage commercial inventory hands-on across DS, bulk DP and finished goods, including replenishment, monthly reconciliation, FEFO compliance and batch traceability. 

• Coordinate batch disposition with Quality and the release of finished goods to the 3PL. 

3PL & Distribution 

• Manage the 3PL day to day (inbound receipts, compliant storage, shipments, distribution performance and issue resolution) to keep product continuously available to the specialty pharmacy network. 

• Partner with Trade & Distribution on order processing, channel data and customer-facing supply issues. 

Compliance & Organization Build 

• Ensure commercial manufacturing, packaging, serialization, storage and distribution comply with cGMP, GDP, DSCSA and applicable regulatory requirements; support audits, inspections and regulatory submissions. 

• Build the commercial supply function as Olema scales, including systems, processes and future planning and logistics roles. 

QUALIFICATIONS 

• BS/MS/PhD in Chemistry, Chemical Engineering, Pharmacy or a related scientific discipline with 15+ years in pharmaceutical CMC, manufacturing or commercial supply; or a business degree with 15+ years of relevant CMC/manufacturing leadership experience. 

• Demonstrated small-molecule commercial launch experience, including registrational readiness, PPQ, process validation and the transition from late-stage development to commercial supply; US launch experience strongly preferred. 

• Extensive experience governing CDMOs across DS and DP (tech transfer oversight, performance management, issue escalation, supply and quality agreements), including negotiating commercial supply agreements. 

• Hands-on commercial supply chain experience: supply planning/S&OP, inventory management, 3PL and specialty distribution, and DSCSA serialization. 

• Strong understanding of US and global regulatory requirements for the manufacture, testing, release and control of commercial small-molecule products. 

• Track record of presenting recommendations, risks and mitigation scenarios to executive management, and of influencing internal teams and external partners through strong communication and negotiation. 

• Leadership experience  

ATTRIBUTES 

• Strategic and hands-on: shapes the commercial supply platform and does the daily work a lean, build-from-scratch organization requires. 

• Urgent and decisive: acts quickly on time-sensitive launch and supply risks, with high accountability for results. 

• Analytical: simplifies complex issues into clear, actionable decisions. 

• Collaborative: low-ego leadership style aligned with Olema’s culture and launch needs. 

The base pay range for this position is expected to be $260,000 - $285,000 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.

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