Job description
The Role:Moderna is seeking an Associate Director, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies and other internal software systems. This person will be required to oversee external IRT vendors (performance and day-to-day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business and digital functions (e.g. Program Management, Biostatistics, Informatics Engineering, Data Science and AI). This position will work collaboratively across several planning and operations systems as well as cross-functionally to gather relevant business requirements and utilize the available resources to create the system architecture, support the system design and development, and ensure the 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, and the ability to pursue multiple options in parallel to meet project timelines.
Here’s What You’ll Do:
Manage IRT Systems for Programs and Processes at Moderna
Responsible for IRT requirements, user acceptance testing, and management
Responsible for overseeing a team of people dedicated to IRT management and operations
Report on key metrics and ensure IRT system health for the duration of the study
Discover and gather system requirements needed to support the CDO organization
Analyze the system requirements, prototype early-stage solutions, and design IRT systems
Rollout new and key growth functionality that will have a high impact and shape the future of the IRT industry
Manage business review meetings
Manage user requirements, functional requirements, user acceptance testing, and system delivery
Collaborate with the digital teams on the design, development, and delivery of new capabilities
Collaborate with the digital teams and external vendors on data integrations; develop best practices for external data integrations
Generate and review business processes as required and ensure compliance with all relevant SOPs and regulations
Implement industry best practices for clinical supplies planning and operations
Collaborate with users on the clinical supply systems implementation so all clinical drug supply needs are met
Monitor and track software development lifecycle to ensure smooth adoption
Here’s What You’ll Bring to the Table:
At least seven to ten years of clinical supply systems experience in a clinical research environment
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 experience required
IRT Subject Matter Expertise
Prior biopharmaceutical, pharmaceutical, or chemical manufacturing experience preferred
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 c andidate 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
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-TR2
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