Director, Clinical Supply Chain Operations
Insmed Incorporated
9 hours ago
Remote friendly (Bridgewater, NJ)
United States
Operations
About The Role
- Director, Clinical Supply Chain Operations on the Clinical Supply Chain team; lead global demand planning and ensure successful delivery of Investigational Material(s).
- Develop and execute strategic plans for production, packaging, distribution, and clinical supply budgeting; provide leadership across Clinical Supply Chain & Logistics and key role on the leadership team.
What You'll Do
- Develop, coordinate, and manage clinical supply activities: demand/production planning, clinical packaging (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics.
- Define sourcing strategies and engage CMOs, CROs, 3PLs, IXRS/IRT vendors; lead vendor selection and performance monitoring.
- Establish KPIs/scorecards/governance; conduct continuous improvement reviews.
- Translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global markets.
- Support clinical supply budgets and global financial forecasts.
- Mentor/manage clinical supply direct reports; update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance.
- Ensure compliance (eTMF documentation, audit readiness), support IND/CTA/IMPD, act as SME during inspections; assess and mitigate supply interruption risks.
- Collaborate on system design/UAT/maintenance for supply tracking and randomization; align with D&OP/S&OP and digital transformation efforts.
- Oversee depot inventory, labeling strategies, temperature excursion management, import/export logistics, and patient supply continuity.
Who You Are
- Bachelor’s degree in science or business; 10+ years leading clinical supply chain and logistics.
You Are Or You Also Have
- Ability to lead in a highly matrixed environment and build cohesive cross-functional teams.
- Experience across Clinical/Regulatory/Quality; expert knowledge of drug development phases and project management.
- Extensive experience planning and executing investigational materials supply strategies.
Nice To Have
- Master’s degree/MBA and some development experience.
Application
- Hybrid role based in Bridgewater, NJ; occasional travel (~25%). Pay range: $177,000–$242,000 annual.
- Director, Clinical Supply Chain Operations on the Clinical Supply Chain team; lead global demand planning and ensure successful delivery of Investigational Material(s).
- Develop and execute strategic plans for production, packaging, distribution, and clinical supply budgeting; provide leadership across Clinical Supply Chain & Logistics and key role on the leadership team.
What You'll Do
- Develop, coordinate, and manage clinical supply activities: demand/production planning, clinical packaging (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics.
- Define sourcing strategies and engage CMOs, CROs, 3PLs, IXRS/IRT vendors; lead vendor selection and performance monitoring.
- Establish KPIs/scorecards/governance; conduct continuous improvement reviews.
- Translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global markets.
- Support clinical supply budgets and global financial forecasts.
- Mentor/manage clinical supply direct reports; update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance.
- Ensure compliance (eTMF documentation, audit readiness), support IND/CTA/IMPD, act as SME during inspections; assess and mitigate supply interruption risks.
- Collaborate on system design/UAT/maintenance for supply tracking and randomization; align with D&OP/S&OP and digital transformation efforts.
- Oversee depot inventory, labeling strategies, temperature excursion management, import/export logistics, and patient supply continuity.
Who You Are
- Bachelor’s degree in science or business; 10+ years leading clinical supply chain and logistics.
You Are Or You Also Have
- Ability to lead in a highly matrixed environment and build cohesive cross-functional teams.
- Experience across Clinical/Regulatory/Quality; expert knowledge of drug development phases and project management.
- Extensive experience planning and executing investigational materials supply strategies.
Nice To Have
- Master’s degree/MBA and some development experience.
Application
- Hybrid role based in Bridgewater, NJ; occasional travel (~25%). Pay range: $177,000–$242,000 annual.