Manager, Clinical Supply Chain

About the role

We're looking for a Manager, Clinical Supply Chain on the Clinical Supply Chain & Logistics team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Head of Clinical Supply Chain & Logistics, you’ll be responsible for managing inventory and demand plans for assigned studies and projects.

Responsibilities

• Assist in developing demand and supply plans for assigned studies and/or programs
• Assist in overall production planning from raw material manufacturing through finished good demand planning and scenario planning
• Serve as main point of contact for clinical supply on designated studies and projects
• Support IRT system design and UAT requirements for assigned studies
• Day-to-day management of primary and secondary inventory
• Career with and/or managing external vendors
• Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects.
• Communicate relevant project information to internal and external stakeholders
• Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities
• Aid in developing study or program level supply assessments
• Develop and approve clinical labels through collaboration with Regulatory CMC, Clinical Operations and Quality Assurance
• Identify, report, manage and mitigate risks in the clinical supply chain
• Provide regular updates to the TMF as per regulatory requirements
• Understand and contribute to the budget process
• Collaborate with internal stakeholders to ensure supply availability at each node within the supply chain.
• Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics and budget/invoice tracking
• Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material.
• Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements.
• Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results.
• Ability to identify risks in process management and develop a solution-based approach that is operationally achievable.

Requirements

• Bachelor’s degree along with 4 years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations.
• Proficient with Microsoft Applications (Excel, PowerPoint, Word). MS Project and other computer software demand & supply related systems are a plus.
• Working knowledge of GMP, GCP and ICH guidelines
• Strong teamwork and collaboration skills.
• Strong ability to handle multiple projects simultaneously.
• Acts with a sense of urgency.

Qualifications

• Experience working with and/or managing external vendors
• Strong ability to handle multiple projects simultaneously.
• Acts with a sense of urgency.

Skills

• Proficient with Microsoft Applications (Excel, PowerPoint, Word).
• MS Project and other computer software demand & supply related systems are a plus.
• Experience working with and/or managing external vendors
• Strong teamwork and collaboration skills.
• Strong ability to handle multiple projects simultaneously.
• Acts with a sense of urgency.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• 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
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Pay

$124,000.00-161,000.00 Annual