Director, Global Clinical Supply Chain – Late-Phase

Olema Oncology; Cambridge (MA); On-site; USD 205,000 - 235,000; Full time

Job summary

Olema Oncology is seeking aDirector, Clinical Supply Chain to oversee all aspects of the clinical supply chain for late-stage programs. You will partner with Clinical Operations, CMC/Technical Operations, Quality, Regulatory and external vendors to ensure uninterrupted drug supply and readiness for NDA submissions.

The role requires extensive experience in end-to-end clinical supply chain management, a track record in late-phase trials, and strong GMP/regulatory knowledge.

Qualifications

• Late phase clinical development and global clinical supply chain management experience is required.
• 15+ years in biotech/pharmaceutical industry with 8+ years in clinical supply chain.
• Experience leading end-to-end clinical supply strategy for global programs.
• Strong knowledge of GMP and global regulations governing clinical supplies.

Responsibilities

• Lead end-to-end clinical supply chain strategy and execution for a global, late-stage clinical program.
• Provide leadership across clinical supply planning and execution, including alignment with manufacturing and release schedules and oversight of CDMOs and external partners.
• Develop and implement global Clinical Supply Chain strategies for all phases of development.
• Develop demand forecasts and executable supply plans based on enrollment, site activation, dosing, and manufacturing timelines.

Skills

Leadership

Cross-functional collaboration

Project management

Communication

Strategic thinking

Ownership

Education

Bachelor's degree in a scientific/engineering field

Advanced degree preferred

Tools

IRT/RTSM

QMS

Inventory management systems

Forecasting tools

Job description

Olema Oncology is seeking aDirector, Clinical Supply Chain to oversee all aspects of the clinical supply chain for late-stage programs. You will partner with Clinical Operations, CMC/Technical Operations, Quality, Regulatory and external vendors to ensure uninterrupted drug supply and readiness for NDA submissions.

The role requires extensive experience in end-to-end clinical supply chain management, a track record in late-phase trials, and strong GMP/regulatory knowledge.