About the Role: The Associate Director, Biomarker and Assay Development will report to the Senior Director, Translational Research, and will lead biomarker strategy, assay development, fit-for-purpose assay qualification and validation, bioanalytical sample analysis oversight, and regulatory readiness across in vivo gene editing programs. Please note that this is primarily an office-based leadership role with close engagement with laboratory and external partner activities. This is not a remote position, and on-site presence is required in our Cambridge office, typically 4-5 days per week.
What You Can Expect:- Serve as the Biomarker & Assay Development lead on cross-functional program teams
- Develop and execute biomarker and bioanalytical assay strategies to support in vivo gene editing programs from discovery through IND-enabling studies
- Design, oversee, and interpret translational and preclinical studies, including studies evaluating editing activity, target engagement and pharmacodynamic response, biodistribution, safety biomarkers, and disease-relevant endpoints
- Lead assay development, vendor selection, qualification, validation, transfer, and troubleshooting, working closely with internal teams and external CROs/vendors
- Select, manage, and oversee CROs to ensure high-quality, timely delivery of study results and assay data
- Integrate biomarker and assay data into program decision-making and regulatory documentation
- Collaborate with clinical team to coordinate management of study samples, timing and cadence of bioanalytical sample analysis, QC of assay runs, data analysis and presentation of data
- Manage, mentor, and develop a team of 3-4 research associates
What You Bring: - PhD or equivalent experience in biology, pharmacology, molecular biology, bioengineering, or a related field
- 8+ years of relevant industry experience in biomarker development, bioanalytical assay development, translational research, or preclinical development
- Deep expertise in bioanalytical assay methods, development, qualification, and validation, ideally in support of genetic medicine, AAV, RNA, or gene editing programs
- Experience with relevant assay platforms and readouts such as qPCR/ddPCR, ELISA/MSD, flow cytometry, NGS, biodistribution, editing efficiency, immunogenicity, RNA/protein biomarkers, or other molecular/cellular assays
- Experience supporting IND-enabling studies, GLP toxicology studies, and regulatory documentation
- Strong ability to synthesize complex biomarker and assay data into clear recommendations for program teams and leadership
- Strong understanding of regulatory expectations for bioanalytical assays, translational biomarkers, and preclinical study packages
- Experience managing CROs/vendors and ensuring quality, timelines, and scientific rigor
- Prior experience with AAV or other genetic medicine delivery platforms required; gene editing experience strongly preferred
- Demonstrated experience managing and mentoring research associates and/or junior scientists
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment
- Excellent planning, organization, communication, and interpersonal skills
The anticipated salary range for candidates for this role will be $XX - $XX. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.
