Sr. Manager, Clinical Supplies Project Manager

ModernaTX • Cambridge, MA

1d • Onsite

About The Position

Moderna is seeking a Sr. Manager, Clinical Supplies Project Management to manage the clinical supplies needs across its projects, as well as work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be skilled at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.

Requirements

• At least 5 -8 years of clinical drug supply management/clinical supply chain/clinical supplies experience in a clinical research environment is preferred
• Bachelor’s degree in a science-based subject
• Prior Cold Chain packaging, labeling, distribution experience required
• IRT design and management experience required.
• Clinical Supplies Planning and Forecasting experience required
• Experience with Clinical Supply Inventory Management systems required
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
• Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas.
• Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

Responsibilities

• 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 as necessary
• Participate in business review meetings with third party drug supply vendors
• Responsible for IRT requirements, user acceptance testing, and management
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives
• Develop and compile KPIs (metrics)
• 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 ensure 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

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Manager