Associate Director, Clinical Supplies Systems

The Role:
Moderna is seeking an Associate Director, Clinical Supplies Systems to oversee and manage IRT systems for Modernas 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 Modernas 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.

Heres What Youll 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

Heres What Youll Bring to the Table:

• At least seven to ten years of clinical supply systems experience in a clinical research environment

• Bachelors 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 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

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
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 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. Were 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)

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