Senior Director, Bioanalytical and Biomarker Development

Senior Director, Bioanalytical And Biomarker Development

Editas Medicine is seeking a strong scientific and strategic leader to join our DMPK, Nonclinical Safety and Translational Sciences (DSTS) group. This highly visible role will be accountable for the preclinical bioanalytical strategy, biomarker strategy, data quality, and regulatory readiness, ensuring successful EDIT-401 IND submission and Clinical Trial execution.

The role serves as a critical bridge between DSTS/RTO, Clinical Development, and CMC working closely with Clinical Operations, Regulatory Affairs, and Biostatistics to ensure timelines and regulatory expectations are met.

As the Senior Director, Bioanalytical and Biomarker Development, you will:

• Lead assay development, qualification, validation, and execution for measuring drug product components, immunogenicity, biomarkers, and other analytes in biological matrices.
• Author BioA/BioM strategies and review nonclinical and clinical protocols to ensure alignment with regulatory expectations.
• Design and implement BioA/BioM strategies across discovery, translational, and clinical stages including supporting global trials. Align biomarker plans with program objectives, regulatory expectations, and intended clinical use.
• Author, review, and/or approve bioanalytical reports and regulatory and clinical documents including pertinent sections of non-clinical and clinical protocols.
• Serve as a subject matter expert in resolving complex analytical challenges and integrating cutting-edge technologies.
• Ensure bioanalytical/biomarker studies comply with GXP and other relevant regulatory standards. Partner with compliance teams to identify and qualify CROs and other vendors appropriately.
• Serve as BioA/BioM subject matter expert on program teams and sub-teams.
• Collaborate with CMC to ensure consistent bioanalytical assays between pre-clinical and clinical development.
• Communicate complex scientific concepts effectively to non-expert stakeholders.
• Deliver high-quality data within tight timelines, meeting >95% of R&D development expectations.
• Apply understanding of disease biology and therapeutic mechanisms to guide biomarker strategy in collaboration with discovery team.
• Work closely with Clinical Operations to enable seamless central and specialty laboratory sample analysis for clinical BioA/BioM data.
• Ensure team members feel supported, held accountable, and have documented professional development plans with quarterly check-ins.
• Develop next-level leaders to support current programs and future pipeline targets.
• Develop relationships with external thought leaders to ensure alignment with highest clinical standards and emerging science.
• Monitor industry trends, emerging technologies, and evolving regulatory guidance in bioanalysis and biomarkers. Engage with external consortia, working groups, and regulatory bodies to influence industry standards and best practices.