Senior Director, Commercial Manufacturing and Operations

Olema Oncology•Boston, MA

About The Position

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—including drug substance, drug product, packaging, labeling, serialization, inventory, and distribution—and ensures uninterrupted, cost-effective supply to Olema’s third-party logistics (3PL) and specialty pharmacy network. The Senior Director sets commercial supply strategy, liaises with executive leadership, and owns planning, inventory, vendor, and logistics operations, while building the team as the business grows. The position leads commercial supply strategy and launch readiness; provides operational oversight of drug substance and drug product manufacturing and contract development and manufacturing organizations (CDMOs); oversees packaging, labeling, and serialization; runs supply planning and inventory management; manages 3PL and distribution operations; and ensures compliance with applicable manufacturing, distribution, serialization, and regulatory requirements. The role also builds the commercial supply function, systems, processes, and future planning and logistics capabilities.

Requirements

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

Nice To Haves

US commercial launch experience is strongly preferred.

Responsibilities

Set palazestrant’s commercial supply strategy, including network design, capacity and second-source planning, and launch inventory build decisions.
Own the commercial supply budget, cost-of-goods-sold 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 manufacturing, 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, 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 supply planning (S&OP) cycle, translating the commercial forecast into drug substance, drug product, and packaging plans and establishing 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 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.
Present recommendations, risks, and mitigation scenarios to executive management and influence internal teams and external partners through communication and negotiation.