Job Reference: MR345
Technical Director of Molecular Pathology
- Monmouth Junction, New Jersey
- £0 - £0 per hour
- Permanent / Full Time
Seven Life Science have an amazing opportunity available as a Technical Director of Molecular Pathology, this role is based in Monmouth, New Jersey.
- We are seeking a Technical director of Molecular Pathology to lead the tissue staining and other related techniques at company. This position will report to the CSO.
Salary is negotiable.
- Build and oversee immunohistochemistry (IHC), immunocytochemistry (ICC) and in-situ hybridization (ISH/FISH/CISH) function at company to develop and validate novel assays but also validate or verify off-shelf kits for offering to pharmaceutical clinical trials and standard patient care.
- Lead, oversee, train, manage and demonstrate to bench technologists and junior scientists to develop, optimize, and validate assays.
- Roll sleeves and work on the bench to help his/her team establishing an assay from commercially available raw materials, or troubleshoot a technical issue.
- Suggest, qualify and use materials as positive and negative quality control for each assay.
- Search the market or literature to elect technology and reagents for single antibody and multiplex assays based on biomarker staining pattern and purpose of an assay.
- Provide expert advice on biomarker selection, characterization and development for exploratory research, cancer screening or diagnostic purposes.
- Assess and monitor strategic position and marketplace presence of key competitors in IHC, ICC and ISH, and provide scientific input to company market strategy and competitive positioning.
- Participate in sponsor, CRO, and investigator meetings as requested by business development team or project management.
- Serve as the subject-matter-expert and provide consultation and address client questions in real time.
- If needed, help biopharma clients in developing and implementing IHC/ISH-based biomarkers in translational or late phase clinical trials.
- Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with a drug development, regulatory, and commercial strategies.
- Design assay development and validation plans that fit a client’s purpose of an assay, draft SOPs, assay validation reports and clinical study reports.
- Interact with the CSO and other functions to ensure appropriate resources are established to direct assay development or assay transfer and its implementation.
- Provide the instructions for sample acquisition, processing, storage, shipping and handling needed for a lab manual.
- Work with internal and external operation groups to coordinate activities such as sample management, analysis, and result reporting in real-time or in batches.
- Manage the budget and resources for the overall department.
- PhD in one of the biological sciences with 8+ years or MS with 10+ years of experience in IHC, ISH, ICC at a CRO lab, pharmaceutical company and/or medical institution.
- Track-records for establishing, developing, optimizing and validating novel singlet and multiplex IHC, single-probe and dual probe ISH assays in FFPE tissues – Experience in ICC and CTC phenotyping is a plus.
- Track-records for taking an assay from a hypothesis to utilization in clinical sample analysis with needed quality measurements.
- Knowledge of pharma clinical trial assay, regulatory requirements governing clinical laboratory, companion diagnostics and/or in vitro diagnostics is preferred.
- Experience in qPCR and dPCR is preferred.
- Proven ability to manage clinical translational programs and teams with minimal supervision.
- Self-organized and operate effectively without significant day-to-day oversight, while following the CSO high level instructions and staying connected to key stakeholders.
- Strong interpersonal, organization, time-management, people management, and communication skills.
- Collaborative and teamwork skills.
Working with Seven Life Science:
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