Director, Clinical Supply Chain Operations
BioSpace · Bridgewater, NJ · 2 wk ago
HybridManufacturing$177k–$242k/yrFull-time
About the role
We're seeking a Director, Clinical Supply Chain Operations to join our Clinical Supply Chain team. This role is critical for expanding possibilities for patients with serious diseases. Reporting to the Senior Director, Clinical Supply Chain, you'll oversee global demand planning and the successful delivery of Investigational Material(s) for Insmed therapies.
Responsibilities
- Develop and execute strategic plans for production, packaging, distribution, and clinical supply budgeting
- Lead global demand planning and ensure the successful delivery of Investigational Material(s) for patients on Insmed therapies
- Provide strategic leadership for Clinical Supply Chain & Logistics operations across all clinical programs
- Define and implement comprehensive sourcing strategies, engaging CMOs, CROs, 3PLs, IXRS/IRT vendors and other third-party providers
- Manage clinical supply activities including demand/production planning, clinical packaging (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics for global clinical programs
- Foster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviews
- 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, as well as 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 robust supply tracking and randomization support and 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 Clinical Supply Chain digital transformation (e.g., forecasting tools, dashboards, AI-driven analytics), 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
- 10+ years of experience in handling/leading clinical supply chain and logistics
Qualifications
- Demonstrated ability to work in a highly matrixed environment is essential; ability to develop and lead a high performing team across all levels
- Extensive experience in planning and execution of investigational materials supply strategies
Skills
- Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
Benefits
Insmed offers a comprehensive benefits package including:
- Comprehensive medical, dental, and vision coverage and mental health support
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Pay
$177,000.00 - $242,000.00 Annual
Schedule
This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.
Travel Requirements
This role requires occasional domestic/international travel (approximately 25%).