Sr. Manager, Clinical Biomarkers, Oncology
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 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 expertise in immunoassays, such as multi-color flow cytometry, immunohistochemistry, immunofluorescence, immunogenicity, and emerging technologies such as cell free DNA assessment to implement in Oncology clinical trials.
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.
Develop and 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
Serve as a point of contact for biomarker operations across vaccine teams, and with collaborators, assay labs and CROs.
Contribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays
Here’s What You’ll Bring to the Table:
MS (with at least 6 years pharmaceutical/biotechnology experience) or PhD (with at least 1 year of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, Oncology).
Hands on experience in immunoassays, such as multicolor flow cytometry, immunohistochemistry or immunofluorescence are required. Knowledge in cell free DNA assay, NGS bases assays, Immunogenicity assessment, ELISA based assays are desired.
Experience in CRO management, biomarker assay qualification/validation, 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 winter shut down
• 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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-JR1