Editas Medicine Director (Senior Director), Translational Bioanalytics and Operations - 2251 in Cambridge, Massachusetts
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective molecular modification to treat the underlying cause of a broad range of diseases at the genetic level.
The successful candidate will lead the Translational Bioanalytics and Operation group accountable for translational biomarker strategy, bioanalytical assay development and transfer, clinical assay test and analysis for all gene and cell therapy programs at Editas. This individual will develop and implement strategic biomarker plans and is responsible for design, technical oversight, outsourcing, technology transfer, validation, and documentation for Regulatory submission. The individual will actively participate in program teams, as well as collaborate effectively across functions. The successful candidate shall demonstrate a proven track record in development experience with biologics, nucleic acid-based, or gene therapy products through IND/BLA and solid understanding of FDA/EMA guidelines. This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards and process.
Develop and implement biomarker and bioanalytical strategy in support of preclinical and clinical development of viral (AAV) and non-viral delivered CRISPR-based gene and cell therapy
Collaborate with R&D and clinical teams to translate preclinical POC observations into clinical development plan including patient selection, safety and efficacy endpoints and long-term follow-up plan.
Design, execute, interpretate and report the drug-related specialty clinical biomarkers of target engagement, PD, efficacy, immunogenicity and safety endpoint to support clinical trial
Collaborate with clinical team in CRO selection, CRO governance and management,
Prepare and review clinical biomarker and testing related sections of documents for regulatory submission and participate in regulatory agency interaction. Prepare and review clinical trial site-facing documents including lab manual, patient consent, etc.
Build bioanalytical capability in house, provide appropriate training and mentorship of staff to ensure adherence to quality in process implementation and execution of the studies
Collaborate with Quality organization to establish and maintain high-quality systems for outsourcing, managing and reporting Bioanalytical methods and studies that meet both regulatory guidelines and industry best practices
Ph.D in Immunology, biology or related field of study with minimum of ten years of working experience, including strong track record of hands-on experience in clinical biomarker design and bioanalytical assay development in gene and cell therapy in pharmaceutical and/or biotechnology industry
Working experiences with biologics, nucleic acid, gene and cell therapies is highly desirable
Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Bioanalytical development in support of clinical trials
Experience in outsourcing and managing CROs for regulated (GLP, GCP) Bioanalytical studies
Managerial experiences that demonstrate effective leadership within and cross functional teams
Ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audience both internal and external to Editas, excellent written skills