Associate Director, Biomarker Operations, Clinical Biomarkers

1 day ago

Cambridge, Massachusetts, United States Moderna Full time
The Role: Moderna is seeking a seasoned Associate Director to lead the Biomarker Operations group within the Clinical Biomarkers Department. This position will provide strategic leadership to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs.

Key Responsibilities:
  • Supervise and lead 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.
  • Manage the day-to-day operations for this team, setting and driving priorities, ensuring compliance, training, etc. in collaboration with clinical study teams and biomarker leads.
  • Lead the standardization of biomarker sections of clinical protocols, clinical kit development, lab manuals and consent forms, focusing on innovation and digital opportunities.
  • Strategize and develop creative solutions for process improvements for clinical sample lifecycle from collection to use and destruction by leading cross departmental projects with Clinical Operations, Digital, and Logistics.
  • Manage and elevate CRO sample and logistics issues while creating processes to alleviate the issues.
Requirements:
  • Bachelor's degree in a life science-based subject; advanced degree preferred - experience will be considered in lieu of degree.
  • Minimum of 8 years of clinical sample management which must include sponsor experience.
  • Previous people management experience required.
  • Solid understanding of GCP/ICH is required.
  • Strong communication skills and attention to detail.
  • Demonstrated ability work independently and to multitask.
About Moderna: Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop innovative medicines. We are committed to making a positive impact on society and are seeking talented individuals to join our team.

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