Drug Supply Manager, Clinical Operations
Moderna is seeking a Drug Supply Manager to work across its projects as well as to work with drug supply vendors and CROs. This position reports directly to the Moderna's Head of Therapeutic Operations. This position will work collaboratively across several therapeutic area teams for clinical operations activities of individual development programs.
- Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies necessary.
- Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies.
- Manages/Works with third party vendors, Functional Leads and interface with CMC for Production Planning & Distribution; develops forecast of all drug supply needs and works with CMC department to insure goals are met.
- Generates and reviews processes as required and ensures compliance to relevant SOPs.
- Implements Industry Best Practices and templates for clinical drug supply activities.
- Works with CMC and clinical group on Master Production Schedule so timing of clinical trial drug needs are met.
- Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements.
- Monitors and tracks shipments to ensure smooth transit through the logistical path -including international shipping.
- Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments.
- Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution.
- Develop pharmacy manual in conjunction with relevant cross functional leads.
- Develop drug supply training materials for investigational sites.
- At least five years of drug supply management experience in a clinical research environment
- Bachelor's degree in a science-based subject
- Clinical Trial Management experience
- Prior Cold Chain distribution experience required.
- Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.