Sr. Manager Clinical Supplies Planning and Logistics
Structure Therapeutics
5 hours ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
- Seeking a Clinical Supplies Professional with experience in clinical supply planning and logistics.
- Forecast Investigational Product (IP) supply requirements, manage inventory, and coordinate packaging, labeling, and distribution through 3rd-party vendors for one or more clinical trials.
- Collaborate with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC; and externally with IRT, CROs, and IP Drug Depots.
Essential Duties and Responsibilities
- Manage clinical supply and logistics: demand forecasting/supply planning, label text generation/approval, packaging/labeling operations at vendors, batch record review and release, distribution management, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
- Manage IP vendors (performance, quality, timelines, results, costs), including quote reviews, packaging planning, label proof review, and batch record review.
- Collaborate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Develop packaging and labeling strategy with Clinical Operations and Regulatory Affairs; ensure compliance with SOPs, policies, and regulations.
- Partner with QA for IP documentation compliance, lot numbers, expiration management, release schedules, and GCP adherence.
- Review IP-related study documents and training materials; support regulatory inspections.
- Ensure Trial Master File documentation for IP supply activities.
- Provide input to drug kit randomization specifications and review master kit lists.
Qualifications
- BA/BS required (scientific discipline preferred); other BA/BS with clinical supply experience considered.
- 6+ years in biotech/pharma; at least 3 years in clinical supply management in a small biotech environment.
- Clinical supplies management in blinded studies.
- Preferred: small molecules (capsule/tablet) clinical supply planning and logistics for multi-center blinded global studies.
- Plus: global IP logistics.
- Knowledge of cGMP, GCP, GDP.
- Experience in forecasting, labeling, and distribution in a clinical environment.
Core Skills
- Prioritize multiple activities; flexible with shifting priorities.
- Works well in partially remote US/APAC environment.
- Action-oriented, strong problem-solving, integrity/ethics.
- Organizational skills, result-driven, strategic agility, resilience/flexibility.
Travel: Up to 10%
- Seeking a Clinical Supplies Professional with experience in clinical supply planning and logistics.
- Forecast Investigational Product (IP) supply requirements, manage inventory, and coordinate packaging, labeling, and distribution through 3rd-party vendors for one or more clinical trials.
- Collaborate with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC; and externally with IRT, CROs, and IP Drug Depots.
Essential Duties and Responsibilities
- Manage clinical supply and logistics: demand forecasting/supply planning, label text generation/approval, packaging/labeling operations at vendors, batch record review and release, distribution management, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
- Manage IP vendors (performance, quality, timelines, results, costs), including quote reviews, packaging planning, label proof review, and batch record review.
- Collaborate with external partners (CMOs, CROs, shipping/IRT vendors, study sites) to ensure trial execution.
- Develop packaging and labeling strategy with Clinical Operations and Regulatory Affairs; ensure compliance with SOPs, policies, and regulations.
- Partner with QA for IP documentation compliance, lot numbers, expiration management, release schedules, and GCP adherence.
- Review IP-related study documents and training materials; support regulatory inspections.
- Ensure Trial Master File documentation for IP supply activities.
- Provide input to drug kit randomization specifications and review master kit lists.
Qualifications
- BA/BS required (scientific discipline preferred); other BA/BS with clinical supply experience considered.
- 6+ years in biotech/pharma; at least 3 years in clinical supply management in a small biotech environment.
- Clinical supplies management in blinded studies.
- Preferred: small molecules (capsule/tablet) clinical supply planning and logistics for multi-center blinded global studies.
- Plus: global IP logistics.
- Knowledge of cGMP, GCP, GDP.
- Experience in forecasting, labeling, and distribution in a clinical environment.
Core Skills
- Prioritize multiple activities; flexible with shifting priorities.
- Works well in partially remote US/APAC environment.
- Action-oriented, strong problem-solving, integrity/ethics.
- Organizational skills, result-driven, strategic agility, resilience/flexibility.
Travel: Up to 10%