Moderna Therapeutics - Cambridge, MA

posted 3 months ago

Full-time - Senior
Remote - Cambridge, MA
Professional, Scientific, and Technical Services

About the position

The Digital Principal Product Manager for Clinical Data at Moderna plays a pivotal role in shaping the data and analytics infrastructure for a rapidly growing mRNA drug development organization. This position is essential in transforming the biotech industry by leading efforts to identify gaps in the current clinical data standardization processes and management. The successful candidate will implement a unified and intelligent platform that supports the clinical data flow from the initial trial concept definition to the final data submission. This role is not just about managing data; it’s about generating insights from that data to guide clinical development effectively. In this role, you will partner closely with clinical data management and biostatistics groups to drive and execute the data and analytics strategy. You will collaborate with various business stakeholders to understand their needs and identify gaps between the current and future states of data processes, automation, and insight generation. A significant part of your responsibility will be to drive data standardization and ensure data quality throughout the clinical data management process, influencing stakeholders with well-designed data policies and solutions. Additionally, you will work alongside data engineering, informatics, and data science teams to develop modern analytics applications that utilize AI/ML and cloud-based technologies for proactive clinical data management. This position requires a strong understanding of the clinical trial data flow, industry data standards, and the ability to lead product development initiatives successfully. The role is based in Moderna's new LEED-certified headquarters in Cambridge, MA, with an expectation of being in the office 70% of the time, allowing for some flexibility to work from home up to 30%.

Responsibilities

  • Partner 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 teams to develop modern analytics applications for proactive clinical data management using AI/ML and cloud-based technology.

Requirements

  • 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.

Nice-to-haves

  • Proven experience with visualization best practices and data storytelling.
  • 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.

Benefits

  • 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!
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