Director of Biomarkers & Assays, Infectious Diseases Research
As part of the Infectious Diseases (ID) Team, the Director of Biomarkers and Assays will be responsible for bioanalytical and biomarker strategy and assay development and validation to support the discovery, preclinical and clinical evaluation of the ID mRNA vaccines and therapeutics. They will work in partnership with their Moderma Clinical Operations and Pharmacology counterparts to embed the ID biomarkers and assays within the broader company context and to ensure a smooth translation from research to development and validation.
Here’s What You’ll Do:
- Be recognized internally and externally as the Moderna ID subject matter expert on disease and vaccine relevant biomarkers and assays.
- Lead ID biomarker and assay strategy, development, and validation for all discovery and research activities and work with the development biomarker, clinical operations and regulatory teams to support assay translation for clinical development and validation.
- When necessary, identify suitable research and commercial partners for assay development and qualification and supervise their delivery to appropriate quality budget and times
- Work closely with the Clinical Operations and Pharmacology biomarker and assay leads to ensure coordinated and effective validation, transfer and qualification of biomarkers and assays.
- Where necessary work with IP, BD and legal teams to protect proprietary assays where relevant.
- Participate in core project teams to create biomarker strategies from discovery onwards.
- Work cross functionally with the ID discovery, research and development teams and supervise a small group of RAs
Here’s What You’ll Bring to the Table:
- PhD in Immunology, Biochemistry or Cell/Molecular Biology
- 10-15years of experience in the development and application of biomarker assays in preclinical and clinical drug development
- Familiar with a wide range of assay formats (PK, immunoassay platforms including Flow cytometry, viral neutralization assays, bactericidal assays, nucleic acid assays)
- Experience of GLP, GCLP guidelines/practises and FDA (and other regulatory authorities) interactions
- Experience with CLIA environment
Here’s What We’ll Bring to the Table:
- Daily on-site catered lunches .
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.