Manager, Clinical Supply Systems

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

Benefits offered by this job

Healthcare

Well-being benefits

Family planning

Generous PTO

Year-end shutdown

Job summary

Moderna Therapeutics Inc. in Cambridge, MA seeks an experienced IRT Lead to autonomously manage Interactive Response Technology (IRT) systems across the clinical portfolio.

You will translate complex clinical and supply requirements into robust system designs and oversee end-to-end lifecycle from requirements through deployment and maintenance. The role emphasizes collaboration with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies and Data Management, with a strong focus on risk

Qualifications

• Experience in clinical supply systems within a biopharma or CRO setting.
• Demonstrated ownership of product-related initiatives in a regulated environment.
• Knowledge of IRT, EDC integrations and cross-functional clinical operations.
• Strong vendor management and relationship-building skills.
• Familiarity with ICH, GAMP, FDA and related clinical research regulations.

Responsibilities

• Manage IRT systems for assigned programs and studies.
• Lead end-to-end IRT implementation activities from requirements to testing and deployment.
• Coordinate with external IRT vendors to meet milestones and deliverables.
• Develop IRT designs based on clinical development and supply needs.
• Create and oversee UAT, risk assessments and documentation.
• Escalate risks and provide strategic options to leadership.

Skills

Clinical supply systems experience

Product ownership experience

IRT expertise

Vendor relationship skills

Regulatory knowledge (ICH, FDA, etc.)

Education

Bachelor’s degree in a science-based subject

Advanced degree preferred

Tools

MS Office (Outlook, Word, Excel, PowerPoint)

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 & decisions. Bring an imaginative and solutions-oriented approach to IRT delivery, demonstrating close attention to detail, a collaborative outlook, positive leadership and willingness to contribute wherever needed to ensure successful study execution. Contribute, when appropriate, to mentoring Clinical Supply Systems Specialists, sharing IRT expertise & 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 & other digital tools to enhance areas such as requirements analysis, documentation, test‑case development, knowledge retrieval & workflow efficiency while operating within Moderna’s applicable quality, compliance & data‑governance requirements. Take on assignments that may expand in scope based on your experience, technical capabilities & evolving needs of Moderna’s clinical portfolio.

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 & maintaining relationships with vendors
• Working knowledge of ICH, GAMP, FDA, IRB/IEC & 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 & SharePoint)

Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions & ideas. Will work collaboratively with multifunctional teams & partners & 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 & direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, & make a meaningful impact. Moderna is a smoke‑free, alcohol‑free & 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 & mental health support
• Family planning benefits, including fertility, adoption & surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days & a discretionary year‑end shutdown
• Savings & investments to help you plan for the future
• Location‑specific perks & extras
• The salary range for this role is $121,600.00 - $194,500.00

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation or equity award, subject to company plan eligibility criteria & 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 & delivered, & a world‑class team. We believe in giving our people a platform to change medicine & an opportunity to change the world. By living our mission, values & mindsets every day, our people are the driving force behind our scientific progress & culture. Together, we are creating a culture of belonging & building an organization that cares deeply for our patients, employees, environment & communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators & Great Place to Work in the U.S. If you want to make a difference & 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.

Equal Opportunities

Moderna is committed to equal employment opportunity & non‑discrimination for all employees & 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.

Accommodations

We’re focused on attracting, retaining, developing & advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds & 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].

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

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 & 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.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies & other entirely novel protein constructs that can have therapeutic activity inside & outside of cells. We have a clear mission to propel the field of mRNA science forward & deliver new medicines to patients & a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams & partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas & routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort & authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency & Moderna & do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act & certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.