Sr. Manager, Clinical Supplies Project Manager

About the role

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. The successful candidate will be skilled at understanding the needs of critical programs with attention to detail, a collaborative outlook, and the ability to manage workload and meet project timelines.

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
• Manage/Work with third-party vendors, Functional Leads, and interface with CMC for Production Planning & Distribution; develop forecast of all drug supply needs and work with CMC department to ensure goals are met
• Generate and review processes as required and ensure compliance to relevant SOPs
• Implement Industry Best Practices and templates for clinical drug supply activities
• Work with CMC and clinical group on Master Production Schedule so timing of clinical trial drug needs are met
• Maintain collaborative relationships with third-party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
• Monitor and track 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, and 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

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 paths for clinical research, bold in proposing creative solutions and ideas, and will work collaboratively with multifunctional teams and partners while being relentless in pursuing successful outcomes

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

Pay

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Schedule

Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.