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
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