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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) currently 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, drug product, packaging, labeling, serialization, inventory, and distribution, ensuring uninterrupted, cost-effective supply to Olema's 3PL and specialty pharmacy network.
Key Responsibilities:
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 drug substance and drug product 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 drug substance, drug product, 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 artwork, regulatory submissions, and compliance with serialization requirements (DSCSA, track-and-trace)
- Manage packaging vendor relationships and quality oversight
Inventory & Distribution:
- Develop and execute the commercial inventory strategy, balancing launch readiness with working capital efficiency
- Oversee distribution logistics, ensuring timely delivery to specialty pharmacies and 3PLs
- Monitor inventory levels and demand forecasting in partnership with Commercial and Medical Affairs
Team Building & Leadership:
- Build and lead the commercial supply team as the business scales post-launch
- Set the tone for operational excellence, cross-functional collaboration, and accountability
Required Qualifications:
- 12+ years of pharmaceutical or biotech commercial supply chain, manufacturing operations, or supply planning experience
- 5+ years in a director-level or equivalent leadership role managing cross-functional teams and P&L accountability
- Deep experience with CDMO/contract manufacturer management, including negotiation, governance, and performance oversight
- Demonstrated expertise in commercial supply strategy, launch planning, and inventory management for pharmaceutical products
- Strong understanding of pharmaceutical manufacturing, quality systems, regulatory requirements (FDA, cGMP), and serialization/track-and-trace compliance
- Experience with specialty pharmacy distribution and 3PL logistics
- Proven ability to work in fast-paced, early-stage or scaling biotech environments
- Excellent project management, analytical, and problem-solving skills
- Strong financial acumen and ability to manage budgets and cost optimization
- Collaborative leadership style aligned with startup culture and launch needs
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, Business, Supply Chain Management, or related field (or equivalent professional experience)
