Senior Director, Commercial Manufacturing and Operations

About Olema Oncology 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. We are advancing our pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant, is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. Our earlier-stage product candidate, OP-3136, is a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. We are headquartered in San Francisco and have operations in Cambridge, Massachusetts. If you're interested in joining Team Olema, learn more about who we are, what we do, and how we do it at www.olema.com. Important Notice: Fraudulent Recruiting Activities 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.

Olema Oncology

Developing better medicines for breast cancer and beyond.

pharmaceuticalsbiotechnologydrug developmentoncologybreast cancernuclear receptorsand small molecules

O

olema.com

51-200 employees

Biotechnology Research

San Francisco, California

2006

Public Company

16k LinkedIn followers

Raised $765.1M

• 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, partnering with CMC Technical, Quality and Regulatory on
• registrational readiness, PPQ, process validation and the transition to
• commercial supply.
• 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.
• 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..
• 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.
• 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.
• 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.

• 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.
• registrational readiness, PPQ, process validation and the transition from
• late-stage development to commercial supply; US launch experience strongly
• preferred.
• 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.
• 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.
• 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.
• $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.
• 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
• 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

• Equity
• Bonus
• Health Insurance