New Jersey Staffing
Director, Clinical Supply Chain Operations
New Jersey Staffing, Bound Brook, New Jersey, us, 08805
Insmed Clinical Supply Chain Operations
Insmed is a global biopharmaceutical company dedicated to transforming patients' lives with serious and rare diseases. Our employees are our most valuable resource, and we are committed to a patients-first mentality. We aim to grow our team with talented individuals who challenge the status quo, solve problems, and work collaboratively with urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we foster an inclusive, diverse, and flexible work environment. The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful delivery of investigational materials for patients on Insmed therapies. This role involves developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics operations across all clinical programs and plays a key role on the Clinical Supply Chain & Logistics Leadership Team. Responsibilities: Develop, coordinate and manage execution of all clinical supply activities including demand/production planning, clinical packaging, labeling, distribution, returns, reconciliation, destruction, and logistics. Define and implement comprehensive sourcing strategies, engaging CMOs, CROs, 3PLs, IXRS/IRT vendors, and other third-party providers in alignment with clinical development and Clinical Operations timelines. Foster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviews. Establish and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partners. Serve as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation. Support the development and monitoring of clinical supply budgets and global financial forecasts. Mentor and manage Clinical Supply managers or direct reports; build operational structure and foster career/talent development. Create, review, and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance. Support Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activities. Support regulatory filings, act as SME during inspections, perform risk assessments, and implement mitigation strategies. Collaborate on system design, UAT testing, maintenance, to ensure robust supply tracking and randomization support. Collaborate with CMC, Clinical Ops, Quality, Regulatory, and Commercial Supply teams to align clinical supply efforts with broader D&OP/S&OP and processes and commercial readiness. Support digital transformation, drive process optimization, resilience, sustainability, and operational excellence. Oversee global depot inventory, labeling strategies, temperature excursion management, import/export logistics, and ensuring patient supply continuity. Requirements: Bachelor's Degree in science or business related field; Masters/MBA in Operations.
Insmed is a global biopharmaceutical company dedicated to transforming patients' lives with serious and rare diseases. Our employees are our most valuable resource, and we are committed to a patients-first mentality. We aim to grow our team with talented individuals who challenge the status quo, solve problems, and work collaboratively with urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we foster an inclusive, diverse, and flexible work environment. The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful delivery of investigational materials for patients on Insmed therapies. This role involves developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics operations across all clinical programs and plays a key role on the Clinical Supply Chain & Logistics Leadership Team. Responsibilities: Develop, coordinate and manage execution of all clinical supply activities including demand/production planning, clinical packaging, labeling, distribution, returns, reconciliation, destruction, and logistics. Define and implement comprehensive sourcing strategies, engaging CMOs, CROs, 3PLs, IXRS/IRT vendors, and other third-party providers in alignment with clinical development and Clinical Operations timelines. Foster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviews. Establish and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partners. Serve as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation. Support the development and monitoring of clinical supply budgets and global financial forecasts. Mentor and manage Clinical Supply managers or direct reports; build operational structure and foster career/talent development. Create, review, and update SOPs, pharmacy manuals, Investigator Brochures, and handling guidance. Support Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activities. Support regulatory filings, act as SME during inspections, perform risk assessments, and implement mitigation strategies. Collaborate on system design, UAT testing, maintenance, to ensure robust supply tracking and randomization support. Collaborate with CMC, Clinical Ops, Quality, Regulatory, and Commercial Supply teams to align clinical supply efforts with broader D&OP/S&OP and processes and commercial readiness. Support digital transformation, drive process optimization, resilience, sustainability, and operational excellence. Oversee global depot inventory, labeling strategies, temperature excursion management, import/export logistics, and ensuring patient supply continuity. Requirements: Bachelor's Degree in science or business related field; Masters/MBA in Operations.