Strategic Commercial Manufacturing & Supply Leader

Olema Oncology; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Olema Oncology is seeking a Senior Director of Commercial Manufacturing & Operations to lead end-to-end supply for palazestrant. This role oversees DS/DP, packaging, serialization, inventory, and distribution, coordinating with 3PL and specialty pharmacy partners to ensure uninterrupted, cost-effective supply.

You will set the commercial supply strategy, budget, and vendor relationships while guiding the team through NDA, PDUFA, and market entry.

Responsibilities

• Set the commercial supply strategy for palazestrant, including network design, capacity and launch inventory build.
• 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 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.
• 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.
• 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.
• Coordinate 3PL distribution to ensure on-time delivery.

Job description

Olema Oncology is seeking a Senior Director of Commercial Manufacturing & Operations to lead end-to-end supply for palazestrant. This role oversees DS/DP, packaging, serialization, inventory, and distribution, coordinating with 3PL and specialty pharmacy partners to ensure uninterrupted, cost-effective supply.

You will set the commercial supply strategy, budget, and vendor relationships while guiding the team through NDA, PDUFA, and market entry.