Senior Director, Bioanalytical and Biomarker Development

Editas Medicine•Cambridge, MA

21h

About The Position

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. At Editas Medicine, we are a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what is possible in medicine, come join us and become an Editor! 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.

Requirements

PhD or equivalent advanced degree in biochemistry, medicinal chemistry, biology, or related field with 10+ years of relevant industry experience.
Experience in bioanalytical sciences within a regulated drug development environment.
Strong knowledge of regulatory requirements and strategic application of bioanalytical and biomarker methods.
Excellent verbal and written communication skills across all levels both within an organization and with external collaborators/companies with the ability to recognize, articulate, and accept calculated risks to make informed decisions.
Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies.
Proven leadership in cross-functional teams and external collaborations; mentor mid-level and junior level scientists.
Experience working on clinical trials.

Nice To Haves

Experience with LNP and gene therapy is highly desired.
Desirable personal attributes including team player mindset, highly collaborative skills and independence, strong organization, demonstrated ability to work in a fast-paced environment and attention to detail.

Responsibilities

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.