We are seeking a Technical director of Molecular Pathology to lead the tissue staining and other related techniques. This position will report to the CSO.
Duties Will Include the Following:
Build and oversee immunohistochemistry (IHC), immunocytochemistry (ICC) and in-situ hybridization (ISH/FISH/CISH) function at 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 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.
Education
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.
Experience
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.
