Associate Director, Clinical Supplies Project Manager

The Role

Associate Director, Clinical Supplies Project Management is responsible for oversight and leadership of clinical supply activities for a program and/or a clinical study. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations. This position works collaboratively across several therapeutic area teams and cross functionally to support study needs. May be an individual contributor or lead a team of direct reports, including Clinical Supply Project Managers or Specialists. The role requires skill 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.

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 for the processes surrounding clinical supplies
• Oversee 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 to contribute 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
• Develop and compile KPI (metrics)
• Primary interface with CMC for Production Planning & Distribution; develops best practice for forecast of all drug supply needs
• Manages work with Clinical Packaging Organizations, IRT vendors, and CROs
• Drives the creation/develop 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 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
• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments; and coordinating the work schedule of clinical supplies project managers
• Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution
• Develop pharmacy manuals in conjunction with relevant cross functional leads
• Develop 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 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

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

The salary range for this role is $142,500.00 - $256,500.00. 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.

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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. 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. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, 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. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We're 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.

Moderna is 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 [click to reveal email address] View email address on click.appcast.io .

Export Control NoticeThis 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.#LI-NH1