Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Moderna's 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 clinical trials conducted by Moderna.
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, immunohistochemistry, and other biomarker assays.
Oversee assay development/implementation efforts in the 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.
Be responsible for overseeing vendors for timely and accurate completion of tasks and troubleshooting issues as they develop.
Provide operational input and recommendations into all study-related documentation (including protocol, lab manual, informed consent form, and amendments) 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 biomarker vendors by providing technical expertise in biomarker assays.
Here's What You'll Bring to the Table:
PhD (with at least 1 year of pharmaceutical or biotechnology experience) or MS (with at least 6 years of 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, immunohistochemistry, etc. is required.
Experience in clinical biomarker CRO management is required. Knowledge of relevant biomarker assay qualification/validation requirements and familiarity with assay development under regulated environments (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, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
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 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
