The Role

Lakefront Biotherapeutics is seeking an Associate Director of Clinical Supply Chain to plan and deliver investigational product for its clinical studies. The Associate Director will own clinical supply strategy from demand forecasting through packaging, labeling, distribution, inventory management, and reconciliation. The role will work closely with Clinical Operations, Technical Operations, Quality, Regulatory Affairs, and external vendors to keep studies supplied as enrollment and timelines change. This role is hybrid and the successful candidate must be able to work onsite in our South San Francisco office 2-3 days/week.

What You'll Do

• Develop clinical supply plans and forecasts based on study design, enrollment projections, dosing schedules, site activation, and expiry dating.
• Manage supply requirements for study startup, ongoing enrollment, protocol amendments, and closeout.
• Oversee external partners responsible for packaging, labeling, storage, distribution, and returns or destruction of clinical trial material.
• Develop and review packaging and labeling plans for global studies in collaboration with Quality and Regulatory Affairs, ensuring alignment with applicable ICH guidelines and country-specific requirements.
• Establish inventory targets, monitor stock at depots and clinical sites, and coordinate resupply to reduce the risk of shortages or waste.
• Coordinate international shipments, import requirements, and country-specific labeling with internal teams and qualified partners.
• Manage temperature-controlled storage and transportation, including excursion assessment with Quality and Technical Operations.
• Support the setup and ongoing management of clinical supply functions in interactive response technology (IRT) systems, as applicable.
• Maintain accurate supply records, forecasts, budgets, vendor timelines, and performance measures.
• Identify supply risks early and lead contingency planning for changes in enrollment, manufacturing schedules, or study scope.
• Partner with Quality to ensure activities comply with applicable GxP requirements, approved procedures, and clinical trial documentation standards.

What You Bring

• Bachelor’s degree in supply chain, life sciences, business, or a related field; advanced degree preferred.
• Typically 8 or more years of experience in pharmaceutical or biotechnology supply chain, including substantial experience supporting clinical trials.
• Demonstrated ownership of clinical supply planning, forecasting, packaging, labeling, depot management, and distribution.
• Familiarity with applicable ICH guidelines and regional requirements governing investigational product packaging and labeling for multinational clinical trials.
• Experience managing contract packaging organizations, depots, couriers, and other clinical supply vendors.
• Familiarity with IRT systems, inventory controls, temperature-controlled logistics, and international clinical trial shipments.
• Working knowledge of GMP and GCP requirements relevant to investigational product.
• Strong planning, problem-solving, vendor management, and cross-functional communication skills.
• Experience supporting global studies and injectable biologics preferred.

Base compensation for this position ranges from $180,000 - 200,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.