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Salary: USD 260,000 - 285,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing novel oncology therapies, with a lead product candidate (palazestrant) in Phase 3 trials for metastatic breast cancer. The company is transitioning into a fully integrated oncology company and preparing for commercial launch expected in 2028.
The Senior Director, Commercial Manufacturing and Operations is the senior leader accountable for building, scaling, and governing the commercial manufacturing and supply platform for palazestrant. This role owns end-to-end commercial supply spanning drug substance (DS), drug product (DP), packaging, labeling, serialization, inventory, and distribution. The Senior Director ensures uninterrupted, cost-effective supply to Olema's 3PL and specialty pharmacy network.
Key responsibilities include:
**Commercial Supply Strategy & Launch Readiness:**
- Set the commercial supply strategy for palazestrant, including network design, capacity and second-source planning, and 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:**
- 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 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:**
- Own packaging and labeling strategy, including design, vendor selection, and regulatory compliance
- Oversee serialization implementation and track-and-trace readiness
**Inventory & Distribution:**
- Develop and execute inventory strategy and demand forecasting
- Manage distribution logistics and specialty pharmacy network relationships
**Team Building:**
- Build and scale the commercial supply team as the business grows, establishing processes and governance
The role requires a collaborative, low-ego leadership style aligned with Olema's culture and launch needs. The Senior Director will set strategy, liaison with executive leadership, and own execution of planning, inventory, vendor, and logistics work.
**Requirements:**
- 12+ years of pharmaceutical/biotech commercial supply chain, manufacturing operations, or supply planning experience
- 5+ years in a senior leadership role (Director level or equivalent) managing cross-functional teams and P&L responsibility
- Proven experience launching commercial products in oncology or specialty pharma
- Deep expertise in CDMO management, drug substance and drug product manufacturing, and regulatory compliance (FDA, ICH)
- Experience with packaging, labeling, serialization, and specialty pharmacy distribution
- Strong financial acumen: budget management, COGS analysis, supply chain cost optimization
- Demonstrated ability to build and lead high-performing teams in fast-paced, dynamic environments
- Excellent stakeholder management and executive communication skills
- Experience with supply chain risk management and contingency planning
- Knowledge of tariffs, import/export regulations, and global supply chain considerations
- Collaborative leadership style with ability to work cross-functionally with CMC, Quality, Regulatory, Finance, and Commercial teams
