Senior Director, Commercial Manufacturing and Operations

Olema Oncology•San Francisco, CA

About The Position

Olema Oncology is seeking a senior leader to build, scale, and govern its commercial manufacturing and supply platform for palazestrant. The role owns end-to-end commercial supply across drug substance, drug product, packaging, labeling, serialization, inventory, and distribution, ensuring uninterrupted, cost-effective supply to Olema’s third-party logistics (3PL) and specialty pharmacy network. The Senior Director will set commercial supply strategy, liaise with executive leadership, execute planning, inventory, vendor, and logistics activities, and build the team as the business grows. The role leads launch readiness from NDA submission through PDUFA and market entry, including supply strategy, network and capacity planning, second-source planning, launch inventory, budgeting, COGS inputs, supply cost KPIs, and tariff exposure. It provides business and operational oversight of commercial drug substance and drug product manufacturing, oversees CDMO relationships and commercial supply agreements, and manages production schedules and partner performance. The Senior Director oversees commercial packaging, labeling, serialization, and traceability; runs monthly supply planning; manages commercial inventory and finished-goods release coordination; and manages 3PL operations and distribution performance. The role also ensures compliance with applicable cGMP, GDP, DSCSA, and regulatory requirements, supports audits, inspections, and submissions, and establishes the systems, processes, and future roles needed to grow the commercial supply function.

Requirements

BS, MS, or PhD in Chemistry, Chemical Engineering, Pharmacy, or a related scientific discipline, with 15+ years in pharmaceutical CMC, manufacturing, or commercial supply; alternatively, 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 transition from late-stage development to commercial supply.
Extensive experience governing CDMOs across drug substance and drug product, including tech transfer oversight, performance management, issue escalation, and supply and quality agreements.
Experience negotiating commercial supply agreements.
Hands-on commercial supply chain experience, including 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 influencing internal teams and external partners through strong communication and negotiation.
Leadership experience.
Strategic and hands-on approach, with the ability to shape a commercial supply platform and perform day-to-day work in a lean, build-from-scratch organization.
Urgent and decisive approach, acting quickly on time-sensitive launch and supply risks and demonstrating accountability for results.
Analytical ability to simplify complex issues into clear, actionable decisions.
Collaborative, low-ego leadership style aligned with Olema’s culture and launch needs.

Nice To Haves

US launch experience is strongly preferred.

Responsibilities

Set palazestrant’s commercial supply strategy, including network design, capacity and second-source planning, and 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.
Provide business and operational oversight of commercial drug substance and drug product manufacturing, partnering with CMC Technical, Quality, and Regulatory on registrational readiness, PPQ, process validation, and transition to commercial supply.
Negotiate and own commercial supply agreements; conduct quarterly business reviews and manage performance metrics across drug substance, drug product, packaging, and logistics partners.
Manage CDMO production schedules day to day, resolving issues and escalating as needed to protect supply.
Oversee commercial packaging and labeling vendors, including artwork readiness, labeling specifications, and batch documentation.
Work with IT to ensure serialization, aggregation, and traceability systems are validated, DSCSA-compliant, and integrated with 3PL and specialty pharmacy partners.
Run the monthly S&OP cycle, translating the commercial forecast into drug substance, drug product, and packaging plans and setting safety stock, coverage, and replenishment policies.
Manage commercial inventory across drug substance, bulk drug product, and finished goods, including replenishment, monthly reconciliation, FEFO compliance, and batch traceability.
Coordinate batch disposition with Quality and release of finished goods to the 3PL.
Manage 3PL operations, including inbound receipts, compliant storage, shipments, distribution performance, and issue resolution, to maintain product availability to the specialty pharmacy network.
Partner with Trade & Distribution on order processing, channel data, and customer-facing supply issues.
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.