Sr. Associate, Clinical Supplies Planning and Logistics
Structure Therapeutics
14 days ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary:
Entry level Clinical Supplies Professional to support clinical supply activities including forecasting Investigational Product (IP) supply requirements, packaging, labeling, and inventory management, and managing distribution through 3rd party vendors for multiple clinical trials. Responsibilities include inventory and shipment tracking (spreadsheets and vendor portals), packaging schedule tracking, electronic filing, tracking quality events, and cross-functional study team support with Clinical Operations, Quality, Regulatory, Tech Ops/CMC, and external partners (e.g., IRT, CROs, IP Drug Depots). Reports to Head of Clinical Supplies Planning and Logistics.
Job Responsibilities:
- Participate in clinical supply/logistics: demand forecasting & supply planning; label text generation/approval; packaging & labeling at clinical supply vendors; batch record review; distribution management; temperature excursion, expiry extension; drug return & destruction records; inventory management.
- Manage IP vendors (packaging planning, label proof review, batch record review, weekly meetings).
- Collaborate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Partner with Clinical Operations & Regulatory Affairs on packaging/labeling information and compliance with SOPs/policies/regulations.
- Work with QA on IP documentation compliance (procedures, lot numbers, expiration dates, release schedules); track GCP adherence at sites.
- Review IP-related study documents (pharmacy manual, IP protocol section) and training materials.
- Support regulatory inspection preparation/during inspections.
- Ensure IP supply documentation for Trial Master File; input/review drug kit randomization specifications and master kit lists.
Education/Experience & Skills:
- BA/BS required (scientific discipline or supply chain management preferred).
- 3+ years relevant experience OR supply chain/packaging design with scientific knowledge (GxP environment preferred).
- Global logistics experience a plus; strong preference for cGMP/GCP/GDP/GLP.
- Experience with forecasting, labeling, and/or distribution management.
- 2+ years Microsoft Office (Excel; Smartsheets a plus).
- Prioritization, flexibility with shifting priorities; ability to work in partially remote teams; problem-solving, integrity/ethics, organizational skills.
Travel Required: Up to 10%.
Benefits:
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply through the official career page at BambooHR.
Entry level Clinical Supplies Professional to support clinical supply activities including forecasting Investigational Product (IP) supply requirements, packaging, labeling, and inventory management, and managing distribution through 3rd party vendors for multiple clinical trials. Responsibilities include inventory and shipment tracking (spreadsheets and vendor portals), packaging schedule tracking, electronic filing, tracking quality events, and cross-functional study team support with Clinical Operations, Quality, Regulatory, Tech Ops/CMC, and external partners (e.g., IRT, CROs, IP Drug Depots). Reports to Head of Clinical Supplies Planning and Logistics.
Job Responsibilities:
- Participate in clinical supply/logistics: demand forecasting & supply planning; label text generation/approval; packaging & labeling at clinical supply vendors; batch record review; distribution management; temperature excursion, expiry extension; drug return & destruction records; inventory management.
- Manage IP vendors (packaging planning, label proof review, batch record review, weekly meetings).
- Collaborate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Partner with Clinical Operations & Regulatory Affairs on packaging/labeling information and compliance with SOPs/policies/regulations.
- Work with QA on IP documentation compliance (procedures, lot numbers, expiration dates, release schedules); track GCP adherence at sites.
- Review IP-related study documents (pharmacy manual, IP protocol section) and training materials.
- Support regulatory inspection preparation/during inspections.
- Ensure IP supply documentation for Trial Master File; input/review drug kit randomization specifications and master kit lists.
Education/Experience & Skills:
- BA/BS required (scientific discipline or supply chain management preferred).
- 3+ years relevant experience OR supply chain/packaging design with scientific knowledge (GxP environment preferred).
- Global logistics experience a plus; strong preference for cGMP/GCP/GDP/GLP.
- Experience with forecasting, labeling, and/or distribution management.
- 2+ years Microsoft Office (Excel; Smartsheets a plus).
- Prioritization, flexibility with shifting priorities; ability to work in partially remote teams; problem-solving, integrity/ethics, organizational skills.
Travel Required: Up to 10%.
Benefits:
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply through the official career page at BambooHR.