Moderna is seeking a Associate Directory to drive biomarker assay plans across clinical stage oncology programs. This position reports to Moderna’s Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical teams (internal, external CROs) to ensure biomarker assay development strategy, 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 established and emerging technologies, such as scRNAseq, CITE-Seq, TCR sequencing, NGS, cell free DNA and circulating tumor DNA assessment, and other relevant immunoassays to implement in Oncology clinical trials.
Have a broad understanding of new technological advances in Oncology and potential utilization of these to address current and future needs within the Oncology portfolio
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
Work in collaboration with clinical biomarker lab, translational and research teams to support overall biomarker assay development strategies for oncology programs and bring a deep understanding of relevant biomarker technologies to teams
Contribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays
Here’s What You’ll Bring to the Table:
PhD (with at least 3 years pharmaceutical/biotechnology experience) or MS (with at least 8 years of pharmaceutical/biotechnology experience in an oncology science, expertise in clinical biomarker assay development in highly desirable
In depth knowledge in molecular assays, such as NGS, scRNAseq, cell free DNA evaluation, TCR sequencing, are required. Knowledge in other immunoassays, such as Immunogenicity assessment, ELISA based assays are highly 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:
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