Sr. Manager, Clinical Biomarkers – Therapeutics

The Role:

Moderna is seeking a Clinical Biomarker scientist to develop, drive, and execute biomarker plans across clinical-stage therapeutic programs.  This position reports to Moderna’s Director of Clinical Biomarkers for Therapeutics.  The Sr. Manager/Manager will work collaboratively across multiple clinical teams (internal and/or external CROs) to ensure the 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 and clinical development team and clinical lead to support the clinical biomarker development plan of Moderna’s early-phase therapeutic 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 in order to execute the clinical biomarker plan on time and with good quality

• 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 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 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(s), 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 coordinate broader team activities. Participate in clinical team meetings to represent function.

Here’s What You’ll Bring to the Table:

• MS (with at least 6 years of pharmaceutical/biotechnology experience) or Ph.D. (with at least 2-3 years of pharmaceutical or biotechnology experience) with experience supporting clinical development in rare metabolic diseases

• Broad knowledge of standard and emerging biomarker assay technologies, such as ligand binding assays, LC-MS/MS, gene analysis, and omics approaches, and experience in the application of these to address current and future needs within the therapeutic 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, and familiarity with assay development under a regulated environment (CAP/CLIA, GCP/GCLP, IVDR or equivalent) is preferred.

• Ability to quickly absorb new information and develop an understanding of the target biology, disease indications, and technology platforms

• 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
• 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 servic