Manager, Clinical Supply Systems

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

Benefits offered by this job

Healthcare

Well-being program

Family planning benefits

Generous paid time off

Savings & investments

Location-specific perks

Job summary

Moderna Therapeutics is seeking a Manager, Clinical Supplies Systems to lead IRT systems across Moderna’s studies. You will partner with external vendors and internal stakeholders to design, implement, and deliver IRT solutions on time, maintaining high attention to detail and a collaborative approach.

The role requires 3–6 years in clinical supply systems with strong IRT expertise, vendor management experience, and knowledge of regulatory guidelines.

Qualifications

• Bachelor’s degree in a science-based subject is required; advanced degree preferred.
• Three to six years of clinical supply systems experience.
• Experience with IRT integrations (IRT/EDC) is highly desirable.

Responsibilities

• Manage IRT Systems for assigned programs and studies with autonomy.
• Lead IRT implementation project management, requirements/design, UAT, and maintenance.
• Facilitate IRT support, data changes, and collaboration with Clinical Operations and Monitoring.
• Create UAT test cases and oversee documentation and risk assessments.
• Ensure SOP adherence and document administration in eTMF.
• Coordinate cross-functional scheduling, training, and project meetings.
• Deliver excellent customer service and technical support to Clinical Ops, Biostatistics, and Data Management.
• Serve as IRT Subject Matter Expert across Moderna departments.
• Possibly expand responsibilities with experience.

Skills

IRT systems

Vendor management

UAT & testing

SOP compliance

MS Office proficiency

Problem solving

Cross-functional collaboration

ICH/GAMP/FDA knowledge

Education

Bachelor’s degree in science

Tools

MS Office

Job description

The Role

Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This person will be required to work with external IRT vendors (day‑to‑day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business. This position will work collaboratively and cross‑functionally to gather relevant requirements and utilize the available resources to create the IRT system design, provide subject matter expertise, and ensure expert and on‑time IRT system delivery and implementation. The successful candidate is a subject matter expert at IRT‑related integrations, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time. Forecasting applications and IRT product management background are a plus. Managers are expected to independently manage studies or oversee a small portfolio of programs and associated studies, contributing their expertise in IRT system management. They are anticipated to operate autonomously, with the Senior Manager/Associate Director serving as the primary contact for risk mitigation and issue escalation.

Here’s What You’ll Do

• Under the guidance of a Senior Manager or Associate Director, manage IRT Systems for assigned program(s) and studies at Moderna with autonomy
• Responsible for IRT implementation project management, IRT requirements and design, user acceptance testing, and maintenance May contribute to mentoring Clinical Supply Systems Specialists
• Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals
• Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment creation, etc.
• Adheres to processes and ensure compliance to relevant SOPs
• Responsible for administration and uploading documentation to appropriate eTMF
• Collaborates cross‑functionally to schedule projects, end‑user training, meetings, and discussions
• Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management under the directive of the Senior Manager
• Serve as IRT Subject Matter Expert to other Moderna departments
• Task assignments may expand in scope based on the individual's level of experience

Here’s What You’ll Bring to the Table

• 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 collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

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. 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. 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 [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.

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 and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and 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 and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and 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 and authorized for a specific position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.