Dir/Sr. Director, Translational Bioanalytics & Operations

Company: HireMinds
Location: Cambridge
Posted on: June 24, 2022

Job Description:

Our Gene Therapy client in Cambridge, MA is looking to add a Director /Sr. Director to lead their Translational Bioanalytics and Operations team! This group is accountable for translational biomarker strategy, bioanalytical assay development and transfer, clinical assay test and analysis for all gene and cell therapy programs.
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.
Responsibilities:

• 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, interpret 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
  Requirements:
  • Ph.D in Immunology, biology or related field of study with minimum of 10 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

Keywords: HireMinds, Cambridge , Dir/Sr. Director, Translational Bioanalytics & Operations, Executive , Cambridge, Massachusetts