Associate Director, Clinical Supply Chain

Position Summary:

Terremoto Biosciences is located in South San Francisco and is seeking an Associate Director of Clinical Supply Chain within the technical operations group. Reporting to the Head of Technical Operations, the incumbent will be required to work flexibly across multiple small molecule programs and play a key role in the clinical supply management of finished goods, forecasting, packaging, labelling, storage, and distribution for all Terremoto clinical programs. This role demands excellent communication skills and cross-functional collaboration along with a deep understanding of clinical supply.

Key Responsibilities:

• Manage clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs) for global clinical trials, ensuring timely and efficient delivery of study drugs to sites.
• Ensure compliance with all relevant regulations and guidelines, including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
• Maintain project timelines and ensure CMO/vendor teams are tracking to key deliverables, critical milestones, and corporate goals.
• Assist CMC teams in scenario planning, risk management, CMO/vendor management, and preparation of regulatory submissions, as needed
• Oversee inventory management and distribution activities, ensuring accuracy, accountability, traceability, and reconcilliation of clinical trial materials.
• Communicate project status, issues, problems, and proposed solutions to management and key project stakeholders in a proactive, timely, and transparent fashion.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Operations, Quality Control, Quality Assurance, and Manufacturing to ensure seamless integration of supply chain activities.
• Develop and implement clinical supply management systems and best practices to ensure consistency and operational effectiveness within and across functions and programs.
• Establish and maintain relationships with external vendors and partners, negotiate contracts, and manage their performance to ensure reliable and cost-effective supply chain solutions.

Professional Experience/Qualifications:

• Bachelor's degree in a scientific field required. Advanced scientific or business degree preferred
• Minimum of 8+ years experience in biotechnology and/or pharmaceutical development
• Strong clinical supply management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GxP regulations
• Strong cross-functional collaboration, communication, and interpersonal skills, with the ability to influence and maintain relationships with stakeholders at all levels
• Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy
• Possesses experience with clinical practices in global studies, from Phase 1 to Late Phase
• Experience with risk management, vendor selection and management, and budgeting

* The anticipated salary range for candidates who will work in South San Francisco, CA is $185,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.