Associate Director, Clinical Supplies Project Manager

The Role

The Associate Director, Clinical Supplies Project Management is responsible for overseeing and leading clinical supply activities for a program and/or a clinical study. The scope includes operational planning and strategy for end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.

Here’s What You’ll Do

• Assists in identifying resources required to manage programs and their associated clinical studies.
• Provides leadership to more junior colleagues by supporting their development through coaching and identifying key opportunities for development.
• Accountable for planning, strategies, and budget management for programs.
• Drives best practice for supply logistics and processes surrounding clinical supplies.
• Oversees process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies.
• 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.
• May contribute to business review meetings with third-party drug supply vendors.
• With Clinical Study Team inputs and IRT PM, responsible for contributing to the development of IRT requirements, user acceptance testing, and supply management after IRT go-live.
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives.
• Develops and compiles Key Performance Indicators (KPIs).
• Manages work with Clinical Packaging Organizations, IRT vendors, and CROs.
• Drives the creation/development of processes that drive best practice for clinical supplies. Implements industry best practices for clinical drug supply activities.
• Collaborates with CMC, clinical, and project management on production schedules to ensure 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.
• Coordinates and schedules drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments; and coordinates the work schedule of clinical supplies project managers.
• Oversees vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives, and issue resolution.
• Develops pharmacy manuals in conjunction with relevant cross-functional leads.
• Develops drug and clinical supply training materials for investigational sites.

Here’s What You’ll Need (Basic Qualifications)

• At least 8 years of clinical supply management experience in a clinical research environment.
• Bachelor’s degree in a science-based subject (advanced degree preferred).
• Prior cold chain distribution experience required.
• IRT implementation, design, and management experience 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. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
• Location-specific perks and extras

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.

Our Working Model

We are focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Equal Opportunities

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants regardless of criminal histories, religious beliefs, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Accommodations

We are committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.