Manager, Clinical Supply Chain (EDG-2026029)
Edgewise Therapeutics
8 hours ago
Remote friendly (United States)
United States
$130,000 - $160,000 USD yearly
Operations
Manager, Clinical Supply Chain
Responsibilities:
- Manage labeling, transportation, storage, and distribution of clinical trial material for global clinical studies.
- Develop and maintain clinical supply forecasts to ensure accurate demand and inventory levels for finished product; use planning tools to evaluate supply scenarios and support manufacturing planning.
- Facilitate and manage vendors for labeling and distribution of clinical study operations, study contracts, label translations, and supporting services.
- Identify and manage vendors for sourcing ancillary supplies and comparator materials.
- Collaborate with Clinical Operations to align global supply strategy for clinical study IP with study protocols.
- Work with Global Medical Affairs to define global supply strategy for IP supporting Investigator Initiated Trials (IITs) and collaborative studies, in alignment with study protocols.
- Support Clinical Operations with setup, maintenance, and oversight of interactive response technology (IRT) systems for investigational product management.
- Coordinate with Quality Assurance, Regulatory Affairs, Clinical Operations, Global Medical Affairs, and Manufacturing/CMC to ensure uninterrupted and compliant IP supply.
- Participate in continuous improvement initiatives for clinical supply chain processes.
- Provide subject matter expertise and contribute to development/review of SOPs, protocols, IRT specifications, vendor documents, and pharmacy manuals.
- Comply with workplace health and safety policies, safe work practices, and company policies/procedures.
- Perform other duties as assigned.
Qualifications/Required Experience:
- BA or BS in science or relevant field.
- 4–8 years of experience in clinical pharmaceutical product supply chain management (or related field), or 2–5 years with an advanced degree (e.g., Pharm.D.).
- Thorough understanding of regulatory requirements for clinical supply labeling and distribution in the US and EU.
- Thorough understanding of cGMP, GCP, GDP.
- Knowledge of supply chain principles.
Skills/Required:
- Strong organizational, analytical, and interpersonal skills.
- Strong Microsoft Office skills.
- Ability to work in a fast-paced environment with multiple projects.
- Strong relationship management skills and enthusiasm for continuous development.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) with match, and paid time off.
Application instructions:
- No deadline; applications are accepted on an ongoing basis.
Responsibilities:
- Manage labeling, transportation, storage, and distribution of clinical trial material for global clinical studies.
- Develop and maintain clinical supply forecasts to ensure accurate demand and inventory levels for finished product; use planning tools to evaluate supply scenarios and support manufacturing planning.
- Facilitate and manage vendors for labeling and distribution of clinical study operations, study contracts, label translations, and supporting services.
- Identify and manage vendors for sourcing ancillary supplies and comparator materials.
- Collaborate with Clinical Operations to align global supply strategy for clinical study IP with study protocols.
- Work with Global Medical Affairs to define global supply strategy for IP supporting Investigator Initiated Trials (IITs) and collaborative studies, in alignment with study protocols.
- Support Clinical Operations with setup, maintenance, and oversight of interactive response technology (IRT) systems for investigational product management.
- Coordinate with Quality Assurance, Regulatory Affairs, Clinical Operations, Global Medical Affairs, and Manufacturing/CMC to ensure uninterrupted and compliant IP supply.
- Participate in continuous improvement initiatives for clinical supply chain processes.
- Provide subject matter expertise and contribute to development/review of SOPs, protocols, IRT specifications, vendor documents, and pharmacy manuals.
- Comply with workplace health and safety policies, safe work practices, and company policies/procedures.
- Perform other duties as assigned.
Qualifications/Required Experience:
- BA or BS in science or relevant field.
- 4–8 years of experience in clinical pharmaceutical product supply chain management (or related field), or 2–5 years with an advanced degree (e.g., Pharm.D.).
- Thorough understanding of regulatory requirements for clinical supply labeling and distribution in the US and EU.
- Thorough understanding of cGMP, GCP, GDP.
- Knowledge of supply chain principles.
Skills/Required:
- Strong organizational, analytical, and interpersonal skills.
- Strong Microsoft Office skills.
- Ability to work in a fast-paced environment with multiple projects.
- Strong relationship management skills and enthusiasm for continuous development.
Benefits:
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) with match, and paid time off.
Application instructions:
- No deadline; applications are accepted on an ongoing basis.