Sr. Manager, Clinical Biomarkers - Oncology

The Role:

Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans and assays across clinical stage Oncology programs. This position reports to a Moderna Associate Director of Oncology, Clinical Biomarkers.  The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning, execution, and data delivery of biomarker lab data for Moderna clinical trials and associated assay development and qualification.

Here’s What You’ll Do:

• Bring in depth knowledge and technical expertise in a variety of biomarker assays focusing on immuno-oncology; such as immunogenicity, immunophenotyping, TCR sequencing, scRNA-Seq, cell-free DNA assessment, and other assays.

• Oversee assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for oncology programs.

• Responsible for overseeing vendors for timely and accurate completion of tasks and troubleshoot issues as they develop.

• Provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent forms, and vendor assessment forms) and processes, and ensure collection, delivery and analysis of bio-samples in compliance with these documents as well as GCP/ICH as needed.

• Contribute to the evaluation of bioassay vendors by providing technical expertise in biomarker and sequencing assays

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

• PhD (with at least 2 years of pharmaceutical or biotechnology experience) or MS (with at least 6 years pharmaceutical/biotechnology experience) in a related science focus (e.g., immunology, oncology).

• Hands on experience with biomarker assays such as cell-based immunogenicity assays, multiparametric flow cytometry, multiplex cytokine assays, next-generation sequencing assays, etc. are required.

• Experience in clinical biomarker CRO management is required. Knowledge in relevant biomarker assay qualification/validation requirements and familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.

• Solid experience in the application of biomarkers during clinical development including experience with clinical translational research, development, validation, and implementation of biomarkers in the oncology space.

• Strong communication, organization and record keeping skills are required.  

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,