Digital Principal Product Manager, Clinical Data

The Role:

This role plays a critical part in developing Moderna data and analytics infrastructure for a high-growth mRNA drug development organization that is radically changing the biotech industry. You will lead the effect to identify gaps between the current and future states of clinical data standardization process and management, implement an unified and intelligent platform to support the clinical data flow from initial trial concept definition to final data submission, and generate and use insights from data to guide clinical development.

Heres What Youll Do:

• Parnter with clinical data management and Biostats groups to drive and execute the data and analytics strategy.

• Collaborate with business stakeholders to understand their business needs and identify gaps between the current and future states related to data process, automation, and insight generation.

• Drive the data standardization and data quality in the process of clinical data management and influence stakeholders with designed data policy and solutions.

• Collaborate with data engineering, informatics and data science team to develop modern analytics applications for proactive clinical data management using AL/ML and cloud based technology.

Heres What Youll Need (Minimum Qualifications)

• Bachelor's degree in Science, Biotechnology, Engineering, Computer Science or equivalent required.

• 10+ years of experience in clinical data management and clinical data submission.

• Proven experience with clinical trial data flow, process, and standardization.

• Solid knowledge on a large span of industry data standards: CDISC, STDM, ADaM etc.

• Working knowledge of Medidata Rave.

• Working experience with SAS/R/Python.

• Demonstrated success in leading product development.

• Strong understanding of Agile development methodologies and product lifecycle management.

• First-hand knowledge of technology in a GxP environment and an understanding of data integrity requirements for clinical trials.

• This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Heres What Youll Bring to the Table (Preferred Qualifications):

• Proven experience with visualization best practices and data story telling.

• Tangible experience in defining and implementing AI/ML based solutions for advanced analytics.

• Experience with Computerized System Validation (CSV) and global regulatory requirements for data privacy and protection (GDPR).

• Ability to practice design thinking and human centered design to drive innovative solutions.

• Experience with external vendor management (CRO, central labs, imaging labs etc.).

• Knowledge of EDC adjacent applications like eClinical Solutions.

• You can identify opportunities to use data as an asset to drive operations efficiency and generate novel insights to accelerate processes.

• As a technologist, you know your craft and you are fluent in the digital world. You have first-hand knowledge of SaaS, cloud, and AI technologies in a GxP environment.

• First-hand experience in Product Management operating principles and tools (JIRA, Persona Definitions, Road mapping, and the hierarchy of Initiative:Epic:Story:Task).

• Exceptional leadership, communication, and interpersonal skills to manage and motivate cross-functional team.

• An innovative, problem-solving mindset, with a track record of translating clinical trial challenges into successful digital solutions.

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

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

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.

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.

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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-