Karen (Kay) Gray, Phd, Pmp Email & Phone Number

Responsible for establishing data driven prioritization measures, quality assurance, and control processes for the successful management of the Pharmacodynamic Assay Portfolio and the selection, development, and introduction of innovative cancer therapies in support of Division of Cancer Treatment and Diagnosis’s initiatives at NCI.

Direct drug specific pharmacodynamic biomarker assessment of kinase inhibitors in oncology clinical trials. Manage clinical specimen repository, translational medicine representative on drug specific clinical studies, set up molecular and histopathology services to support identification of correlative oncology biomarkers, coordinate executive discussions with Diagnostic Companies for co-development of companion diagnostic tests with drugs, and wrote biospecimen collection manuals and clinical protocols. Established Good Biobanking Practices for the management of the clinical biorepository.

Manage clinical specimen repository, clinical research sites, and histopathology services to support development of diagnostic oncology molecular assays. -Manage clinical site implementation and external resources (eg CRO's; delegating responsibilities to them and assuring their adherence to SOPs, GCP and FDA regulations). -Molecular Pathology liaison between discovery and development groups drafting study related documents, and participating in the strategy/ selection/ negotiation/ contracting of sites & CRO's and other external providers. -Audit site visits to ensure compliance with ICH/GCPs, participate as active member of project teams, draft regulatory briefing documents.-Developed safety protocols -Due Diligent assessment of Healthcare Information Networks.-Responsible for setting up clinical and scientific experts as ‘Key Opinion Leaders’ to support Research and Development.-Responsible for budget and financial tracking .

Leader of oncology gene and protein target validation for small molecule and antibody drug development programs. -Developed molecular pathology platforms for target validation and screening of small molecule and antibody oncology therapeutic candidates.-Established more thorough credentialing of target by relating gene/protein expression to known histopathological, growth, and differentiation parameters associated with diagnosis, prognosis, and toxicity. -Assessed the current and future needs for new biotechnologies.-Prepared departmental budget, goals, and process improvement plans, and served as departmental liaison to the division executive team.-Member of interdisciplinary executive and scientific teams with a major role in establishing operational guidelines and policies for specific drug development and oncology personalized (biomarker) medicine teams. -Supervised and advised personnel as both direct and indirect reports on team and core technology groups.

Leader and member of teams responsible for strategic planning and management of research projects for drug development in reproductive biology. -Set up in vitro and in vivo 2ndary assays to screen & validate lead compounds for hormone activity.-Initiated the development of a functional genomics program for discovery of new fertility drug targets.-Designed “proof-of-concept” studies to assess therapeutic targets for reproductive indications, including GnRH antagonists, PDE inhibitors, designer estrogens, interleukins and anti-inflammatory drugs.-Supervised and advised personnel as direct/indirect reports from core technology groups.-Drafted project proposals and gained corporate approval. -Prepared budgets, project timelines, presentations, and reports for managed projects.-Established academic research partnerships, and participated in due diligence site visits and scientific product reviews.