Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical-stage rare disease programs. This position reports to Moderna’s Director of Clinical Biomarkers for Therapeutics. The Associate Director will work collaboratively across multiple clinical teams (internal or 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:
Work in collaboration with the research team and clinical lead to support clinical biomarker development plan of Moderna’s early phase rare disease programs
Evaluate and identify right technologies and suitable assays to implement the biomarker plan
Ensure assay labs complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality
Provide scientific inputs on PK & biomarker sample collection, shipment, disposition with support from the Biosample Operations Manager to ensure the timely and efficient delivery of all biomarker operational aspects
Manage and oversee the development plan of the bioassay timelines, budget, risks, and quality
Serve as a primary point of contact for biomarker operations across rare disease research teams, and with collaborators, assay labs, and CROs
Develop and provide operational inputs and recommendations into all study-related documentation (including study protocol, lab manual, informed consent form, investigator brochure, clinical study report, and IND/BLA documents) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH
Lead clinical biomarker subteam meetings and participate in clinical team meetings
Here’s What You’ll Bring to the Table:
MS (with at least 8 years of pharmaceutical/biotechnology experience) or Ph.D. (with at least 3 years of pharmaceutical or biotechnology experience) in related research focuses on rare, metabolic diseases.
Broad knowledge of standard and emerging biomarker assay technologies, such as ligand binding assays, LC-MS, IHC, flow cytometry, and omics approaches, and experience in the application of these to address current and future needs within the rare disease portfolio
Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
Solid experience in the application of clinical biomarkers during the development of assets is preferred, including experience with clinical translational research, assay development validation, troubleshooting, and implementation
Experience in CRO management, biomarker assay qualification/validation, familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.
Ability to quickly absorb new information and development an understanding of the target biology, diseases indications, and technology platform
Strong communication, project management, and organizational skills
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