Director, Clinical Supply Chain Operations

Insmed Inc. • Bridgewater, NJ • 16h ago

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Overview The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful delivery of Investigational Material(s) 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 Responsibilities: Develop, coordinate and manage execution of all clinical supply activities including demand/production planning, clinical packaging (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics for global clinical programs 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 across global markets Support the development and monitoring of clinical supply budgets and global financial forecasts (e.g. comparators, manufacturing demand, packaging & labeling production and distribution) 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 (IND/CTA/IMPD), act as SME during inspections, perform risk assessments for supply interruptions and implement and complete mitigation strategies * Collaborate on system design, UAT testing, maintenance, to ensure

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