Commercial Manufacturing and Operations

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, specialty distributors 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 

• Provide uninterrupted supplies to the 3PL, where the commercial team would take over management.
• Partner with Trade & Distribution as appropriate supporting commercial supplies and plans.

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.

Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert:  We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.