Sr. Specialist, Biomarkers Operations, Clinical Biomarkers

The Role:

Moderna is seeking a Biomarker Operations Sr. Specialist to support the clinical teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs.  This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.

Here’s What You’ll Do:

• Provide logistical support for implementation of clinical biomarker sample management plans in Moderna clinical trials

• Review of biomarker sections of clinical protocols, lab manuals and consent forms, and lead clinical sample kit development.

• Track and manage processes throughout clinical sample lifecycle and biorepository usage

• Ensure standardized language for sample information and standardized processes sample reconciliation

• Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH

• Oversee clinical assay vendors (routine sample analysis meetings, address sample issues, sample shipments)

• Track ongoing biospecimen quality issues at global central labs and 3rd-party vendors

Here’s What You’ll Bring to the Table:

• Bachelor’s degree in a life science-based subject; advanced degree preferred

• Minimum of 3 years of clinical research experience which must include sponsor experience

• Direct experience with clinical sample management

• Prior process development experience is very helpful

• Familiarity with databases is helpful

• Solid understanding of GCP/ICH is required

• Strong communication skills and attention to detail

• Demonstrated ability to multitask

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, the infrastructure 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 people are 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.

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 qual