Associate Director, Biomarker Operations

4 days ago


Cambridge, Massachusetts, United States Moderna Full time
About the Role

Moderna is seeking an experienced Associate Director to lead the Biomarker Operations team within the Clinical Biomarkers Department. As a key member of our team, you will provide strategic leadership and direction to drive the innovation and compliance of biomarker biosample management plans for all clinical trials conducted by Moderna.

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.
  • Responsible for managing 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 create innovative medicines. We are committed to making a positive impact on society and are dedicated to creating a culture of belonging and inclusion. We offer a comprehensive and innovative suite of benefits to our employees, including highly competitive medical, dental and vision coverage options, flexible spending accounts, and a generous paid time off policy.

We are proud to be an equal opportunity workplace and are 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.



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