Associate Director, Clinical Supplies Planning and Logistics
Structure Therapeutics
4 hours ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
Associate Director, Clinical Supplies Planning and Logistics (CSPL). Responsible for forecasting Investigational Product (IP) supply requirements, managing packaging/labeling/distribution via 3rd-party vendors, and developing strategy for later-phase global clinical trials. Contributes to CSPL budgeting/finance and collaborates cross-functionally (Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC) and externally (CROs, IP Drug Depot). Reports to Head of Clinical Supplies Planning and Logistics.
Job Responsibilities
- Manage all aspects of IP supply planning and logistics aligned to study plans, timelines, budget, and clinical development plan.
- Manage IP vendors (selection, RFPs/quotes; performance, quality, timelines, results, costs).
- Coordinate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Lead packaging and labeling strategy in compliance with SOPs/policies/regulations.
- Partner with QA on compliance: IP documentation, procedures, lot numbers, expiration management, and release schedules.
- Manage end-to-end clinical supply/logistics: forecasting, supply planning, blinding/maintenance of blind, IRT start-up through closure, label generation/approval, packaging/labeling ops, release/distribution, temperature excursions, expiry extensions, returns/destruction records, inventory management; input to drug kit randomization specs and master kit lists.
- Develop/review IP-related study documents (pharmacy manual, protocol IP section, SOPs) and training materials; support regulatory inspections.
- Ensure IP supply activity documentation is provided for the Trial Master File.
- Line manage one or more direct reports.
Qualifications
- BA/BS required (preferably scientific) or other BA/BS with clinical supply experience.
- 10+ years biotech/pharma experience; at least 6 years clinical supply management in a small biotech environment.
- Required: small molecules (capsule/tablet) clinical supply planning and logistics for multi-center, blinded global studies.
- Preferred: IP logistics in APAC (manufacturing/import from Asia to US).
- Experience with clinical supplies in large global trials.
- Knowledge of cGMP, GCP, GDP.
- Experience with forecasting, labeling, distribution; proven IRT/RTSM experience.
- Clinical supply/vendor management; knowledge of import/export policies.
Skills/Competencies
- Cross-functional leadership; prioritize multiple shifting priorities; action-oriented problem solving; integrity; organizational skills; result-driven; strategic agility; resilience/flexibility in ambiguity.
Travel Required
- Up to 20%.
Benefits (as stated)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays including winter shutdown.
Compensation Range (as stated)
- Anticipated base pay range: $174,000–$227,000.
Education/Experience/Benefits/Compensation are as stated in the posting.
Associate Director, Clinical Supplies Planning and Logistics (CSPL). Responsible for forecasting Investigational Product (IP) supply requirements, managing packaging/labeling/distribution via 3rd-party vendors, and developing strategy for later-phase global clinical trials. Contributes to CSPL budgeting/finance and collaborates cross-functionally (Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC) and externally (CROs, IP Drug Depot). Reports to Head of Clinical Supplies Planning and Logistics.
Job Responsibilities
- Manage all aspects of IP supply planning and logistics aligned to study plans, timelines, budget, and clinical development plan.
- Manage IP vendors (selection, RFPs/quotes; performance, quality, timelines, results, costs).
- Coordinate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Lead packaging and labeling strategy in compliance with SOPs/policies/regulations.
- Partner with QA on compliance: IP documentation, procedures, lot numbers, expiration management, and release schedules.
- Manage end-to-end clinical supply/logistics: forecasting, supply planning, blinding/maintenance of blind, IRT start-up through closure, label generation/approval, packaging/labeling ops, release/distribution, temperature excursions, expiry extensions, returns/destruction records, inventory management; input to drug kit randomization specs and master kit lists.
- Develop/review IP-related study documents (pharmacy manual, protocol IP section, SOPs) and training materials; support regulatory inspections.
- Ensure IP supply activity documentation is provided for the Trial Master File.
- Line manage one or more direct reports.
Qualifications
- BA/BS required (preferably scientific) or other BA/BS with clinical supply experience.
- 10+ years biotech/pharma experience; at least 6 years clinical supply management in a small biotech environment.
- Required: small molecules (capsule/tablet) clinical supply planning and logistics for multi-center, blinded global studies.
- Preferred: IP logistics in APAC (manufacturing/import from Asia to US).
- Experience with clinical supplies in large global trials.
- Knowledge of cGMP, GCP, GDP.
- Experience with forecasting, labeling, distribution; proven IRT/RTSM experience.
- Clinical supply/vendor management; knowledge of import/export policies.
Skills/Competencies
- Cross-functional leadership; prioritize multiple shifting priorities; action-oriented problem solving; integrity; organizational skills; result-driven; strategic agility; resilience/flexibility in ambiguity.
Travel Required
- Up to 20%.
Benefits (as stated)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays including winter shutdown.
Compensation Range (as stated)
- Anticipated base pay range: $174,000–$227,000.
Education/Experience/Benefits/Compensation are as stated in the posting.