Senior Director, Commercial Manufacturing and Operations

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 a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it's an exciting time to be part of Team Olema.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape - particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day.

If you're ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what's beyond.

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