Associate Director, Clinical Supply Chain

Role Summary

Associate Director, Clinical Supply Chain, reporting to the Senior Director, Clinical Supply Chain, will plan, create, implement, build, and optimize the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Olema’s clinical programs. This role is based in San Francisco or Cambridge and requires about 15% domestic or international travel.

Responsibilities

• End to End clinical supply chain management
• Develop and implement global Clinical Supply Chain strategies
• Manage global inventories, shipping, and third-party manufacturers / logistics providers
• Develop and manage Interactive Response Technologies (IRT) systems
• Oversight packaging, labeling, and distribution activities at multiple vendors
• Generate and manage clinical labels
• Identify supply chain risks, escalate if needed, and close out risk items
• Partner with Clinical Operations to align on assumptions and build clinical supply to meet program demand
• Represent Clinical Supply Chain on study execution teams

Qualifications

• Required: Bachelor’s degree in a related field
• Required: 10+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management
• Required: Late phase clinical development and clinical supply chain management
• Required: Thorough knowledge of Good Manufacturing Practices (GMP)
• Required: Inventory management and third-party logistics oversight
• Required: Extensive experience managing forecast demands
• Required: Prior experience managing global, large, late-stage studies with standard of care drugs
• Required: Strong global shipping and customs experience
• Required: Solid experience developing clinical labels
• Required: Experience developing IRT specifications
• Required: Hands-on experience and troubleshooting proficiency with QMS and purchasing systems
• Preferred: Master’s degree
• Preferred: Experience in oncology trials using small molecules

Skills

• Excellent verbal and written communication
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• A commitment to excellence
• Self-motivated and enthusiastic; fast learner who can identify core project challenges and expeditiously adjust as required
• Teamwork and collaboration; ability to balance team and individual responsibilities and share expertise
• Entrepreneurial mindset and ability to prioritize key work streams
• Demonstrated decision-making ability with incomplete information and professional judgment
• Impeccable professional ethics, integrity and judgment
• Collegial, hard-working, confident, self-starter with a passion for results

Education

• Bachelor’s degree required; Master’s degree preferred