Associate Director, Clinical Biomarkers – Therapeutics

at  Moderna

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 focusing on rare, autoimmune, or metabolic diseases.
Broad knowledge of standard and emerging biomarker assay technologies, such as ligand binding assays, LC-MS/MS, genetic sequencing, 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 the 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 (CAP/CLIA, GCP/GCLP, IVDR 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:
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

THE ROLE:

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 development team to support clinical biomarker development plan of Moderna’s early-phase rare disease programs
Evaluate and identify the right technologies and suitable assays to implement the biomarker plan
Ensure assay labs complete appropriate development, qualification or validation studies to execute the clinical biomarker plan on time and with good quality
Serve as SME to lead the clinical biomarker-related efforts, including the implementation of clinical biomarker plans, vendor selection, assay development and data delivery
Provide scientific inputs on biomarker sample collection, shipment, and disposition with support from the Biosample Operations Manager to ensure the timely and efficient delivery of all clinical 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 therapeutic research and development 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