Manager, Clinical Supply Systems

Moderna Inc.; Cambridge (MA); On-site; USD 122,000 - 195,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning

Generous PTO

Retirement savings

Location perks

Job summary

Moderna Inc. in Cambridge, MA, invites you to take autonomous ownership of Interactive Response Technology (IRT) systems across our clinical portfolio.

You will work with Clinical Operations, Biostatistics, Clinical Supplies and Data Management to design, test, deploy and maintain robust IRT solutions that meet ambitious timelines.

Qualifications

• Three to six years of clinical supply systems experience.
• Bachelor’s degree in a science-based subject (advanced degree preferred).
• Prior Product Ownership Experience preferred.
• Experience with integrations between clinical systems (IRT, EDC, etc.).
• Understanding of Cold Chain distribution and its effect on IRT.
• IRT Subject Matter Expertise.
• Creative, capable problem-solver.
• Vendor relationship management experience.
• Knowledge of ICH, GAMP, FDA, IRB/IEC regulations and clinical protocol requirements.
• MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) proficiency.

Responsibilities

• Autonomously manage IRT systems for assigned programs and studies.
• Lead IRT implementation project management activities across the full lifecycle.
• Collaborate with external IRT vendors to align milestones and deliverables.
• Translate clinical development, supply and operational needs into IRT designs.
• Provide expert guidance on IRT integrations and dependencies.
• Create UAT test cases and oversee testing activities.
• Manage IRT documentation and risk/impact assessments.
• Support study execution through IRT-related operational changes.
• Deliver high-quality customer service to clinical teams and data partners.
• Mentor Clinical Supply Systems Specialists when appropriate.

Skills

IRT systems

Project ownership

Vendor management

Regulatory knowledge

Clinical operations liaison

Problem-solving

Communication with leadership

Data management coordination

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

MS Office

SharePoint

Job description

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Cambridge, Massachusetts, home to our global headquarters and a center of mRNA innovation. Working closely with leading universities and research institutions, our Cambridge team advances groundbreaking science that shapes the future of medicine. We welcome talent driven by innovation and committed to improving global health.

This is an opportunity to take autonomous ownership of Interactive Response Technology (IRT) systems supporting Moderna’s growing clinical portfolio, translating complex clinical development and supply requirements into robust, timely system solutions.

Working cross-functionally with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies, Data Management and external IRT vendors, you will lead IRT implementation activities across assigned programs and studies, from requirements and design through user acceptance testing, deployment, maintenance and ongoing support.

As an IRT subject matter expert and individual contributor, you will combine technical depth, rigorous attention to detail and strong project leadership to manage multiple options in parallel, anticipate risk, support data and operational decisions, and deliver high-quality IRT solutions against demanding clinical timelines.

Here’s What You’ll Do

• Under the guidance of a Senior Manager or Associate Director, autonomously manage IRT systems for assigned program(s) and studies across Moderna’s clinical portfolio, independently managing individual studies or overseeing a small portfolio of programs and associated studies.
• Lead IRT implementation project management activities, including requirements gathering, system design, configuration-related coordination, user acceptance testing, implementation, maintenance and ongoing system lifecycle support.
• Work closely with external IRT vendors on day-to-day operational delivery, ensuring vendor activities, system milestones and deliverables remain aligned with Moderna stakeholders, clinical study requirements and business timelines.
• Collaborate cross-functionally to gather relevant requirements and translate clinical development, supply and operational needs into detailed and effective IRT system designs.
• Apply deep subject matter expertise in IRT systems and IRT-related integrations, anticipating dependencies and ensuring technical solutions support the needs of a complex clinical development operations organization.
• Create UAT test cases and coordinate and oversee user acceptance testing activities, ensuring systems are appropriately evaluated before implementation.
• Oversee and facilitate required signatures and completion of IRT documentation, including the preparation of risk assessments and impact assessments.
• Facilitate IRT operational support and data changes, working closely with Clinical Operations and Monitoring teams to enable study execution and achieve operational goals.
• Provide exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies and Data Management under the direction of the Senior Manager.
• Serve as an IRT Subject Matter Expert for other Moderna departments, providing technical guidance and helping cross-functional partners understand system capabilities, dependencies, risks and potential solutions.
• Collaborate across functions to schedule and coordinate IRT projects, end-user training, meetings and technical discussions.
• Ensure adherence to established processes and compliance with all relevant SOPs throughout IRT system delivery and maintenance.
• Take responsibility for the administration, completion and upload of appropriate IRT documentation into the relevant electronic Trial Master File (eTMF).
• Proactively identify potential delivery risks, pursue multiple options in parallel where needed to maintain timelines, and elevate significant risks or issues to the Senior Manager or Associate Director as the primary escalation point.
• Operate with a high degree of autonomy while maintaining strong communication with leadership and internal stakeholders on delivery status, emerging risks, dependencies and decisions.
• Bring an imaginative and solutions-oriented approach to IRT delivery, demonstrating close attention to detail, a collaborative outlook, positive leadership and a willingness to contribute wherever needed to ensure successful study execution.
• Contribute, where appropriate, to mentoring Clinical Supply Systems Specialists, sharing IRT expertise and supporting capability development while remaining an individual contributor.
• Apply forecasting applications and/or IRT product management experience where relevant; experience in these areas would be an advantage.
• Explore opportunities to use Generative AI and other digital tools to enhance areas such as requirements analysis, documentation, test-case development, knowledge retrieval and workflow efficiency, while operating within Moderna’s applicable quality, compliance and data-governance requirements.
• Take on assignments that may expand in scope based on your experience, technical capabilities and the evolving needs of Moderna’s clinical portfolio.

The key Moderna Mindsets you’ll need to succeed in the role

• “We pursue options in parallel to make the best choice later.”
• “We act with dynamic range, driving strategy and execution at the same time at every step.”

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

• At least three to six years of clinical supply systems experience
• Bachelor’s degree in a science-based subject (advanced degree preferred)
• Prior Product Ownership Experience (strongly preferred)
• Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment
• Understanding of Cold Chain distribution and the effect on IRT
• IRT Subject Matter Expertise
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors
• Working knowledge of ICH, GAMP, 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 collaborative ly with multifunctional teams and partners and will be relentless in pursuing successful outcomes

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.

Pay & 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

The salary range for this role is $121,600.00 - $194,500.00. 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.

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,

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 [e-mail].

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.