Associate Director, Biomarker Operations

4 weeks ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
The Role:

Moderna is seeking a seasoned leader to drive biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs. This role will lead cross-functional teams to innovate and standardize biomarker sections of clinical protocols, clinical kit development, lab manuals, and consent forms.

This position will be responsible for managing the day-to-day operations of a team of biomarker operation team members, who support clinical study biomarker deliverables by developing and implementing biomarker operational strategies for all Moderna clinical trials.

The ideal candidate will have a strong understanding of GCP/ICH and experience in managing teams, setting priorities, ensuring compliance, and training. They will also have a solid understanding of clinical sample management and a proven track record of process improvements.

Key Responsibilities:
  • Lead the development and implementation of biomarker operational strategies for all Moderna clinical trials
  • Manage a team of biomarker operation team members to support clinical study biomarker deliverables
  • Collaborate with biomarker leads, clinical teams, and partner CROs to drive innovation and standardization of biomarker sections of clinical protocols, clinical kit development, lab manuals, and consent forms
  • Develop and implement process improvements for clinical sample lifecycle from collection to use and destruction
  • Manage and elevate CRO sample and logistics issues
Requirements:
  • Bachelor's degree in a life science-based subject; advanced degree preferred
  • Minimum of 8 years of clinical sample management experience, including sponsor experience
  • Previous people management experience required
  • Solid understanding of GCP/ICH
  • Strong communication skills and attention to detail
  • Demonstrated ability to work independently and multitask
What We Offer:
  • Comprehensive and innovative suite of benefits, including 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
  • Discretionary year-end shutdown
  • Volunteer time to participate within your community
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options
About Moderna:

Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to create innovative medicines. We are committed to making a meaningful impact on society and are dedicated to creating a culture of belonging and inclusion.

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.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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