Global Clinical Supply Strategy Lead

Lakefront Biotherapeutics

South San Francisco (CA)

Hybrid

USD 180,000 - 200,000

Full time

35 hours ago
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Benefits offered by this job

Performance bonus
Comprehensive benefits

Job summary

Lakefront Biotherapeutics is seeking an Associate Director of Clinical Supply Chain to plan and deliver investigational products for clinical studies. You will own the clinical supply strategy from forecasting to distribution, coordinating with Clinical Operations, Quality, Regulatory Affairs and external vendors.

The role is hybrid and onsite in South San Francisco 2–3 days/week. You will manage packaging, labeling, shipping, inventory control, and temperature‑controlled logistics across

Qualifications

  • 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.

Responsibilities

  • Develop and manage clinical supply plans and forecasts based on study design and enrollment.
  • Coordinate packaging, labeling, storage, distribution, and returns for trials.
  • Oversee external packaging vendors and depots to ensure compliance and timeliness.
  • Collaborate with Quality and Regulatory Affairs on packaging plans for global studies.
  • Monitor inventory targets and coordinate resupply to prevent shortages.
  • Lead international shipments and country-specific labeling coordination.
  • Manage temperature-controlled storage/transport and excursion assessments.
  • Contribute to IRT system setup and ongoing management where applicable.
  • Maintain accurate supply records, forecasts, budgets and vendor timelines.
  • Identify supply risks and lead contingency planning for changes in enrollment or study scope.

Skills

Planning
Vendor management
Cross-functional communication
Forecasting

Education

Bachelor’s degree in supply chain, life sciences, business, or related field

Job description

Lakefront Biotherapeutics is seeking an Associate Director of Clinical Supply Chain to plan and deliver investigational products for clinical studies. You will own the clinical supply strategy from forecasting to distribution, coordinating with Clinical Operations, Quality, Regulatory Affairs and external vendors.

The role is hybrid and onsite in South San Francisco 2–3 days/week. You will manage packaging, labeling, shipping, inventory control, and temperature‑controlled logistics across

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