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Karen (Kay) Gray Email & Phone Number

Translational Medicine: Pharmaceuticals and Diagnostics Professional at Exelixis, Inc.
Location: San Francisco, California, United States 5 work roles 2 schools
1 work email found @optonline.net LinkedIn matched
✓ Verified Jul 2026 4 data sources Profile completeness 86%

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Current company
Role
Translational Medicine: Pharmaceuticals and Diagnostics Professional
Location
San Francisco, California, United States
Company size

Who is Karen (Kay) Gray? Overview

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Karen (Kay) Gray is listed as Translational Medicine: Pharmaceuticals and Diagnostics Professional at Exelixis, Inc., a with 863 employees, based in San Francisco, California, United States. AeroLeads shows a work email signal at optonline.net and a matched LinkedIn profile for Karen (Kay) Gray.

Karen (Kay) Gray previously worked as Associate Director Translational Medicine at Exelixis, Inc. and Group Leader R&D Diagnostics at Veridex, Llc (A J&J Company). Karen (Kay) Gray holds Phd, Biomedical Sciences - Oncology from University Of Tennessee, Knoxville.

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Email format at Exelixis, Inc.

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kgray@optonline.net
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Profile bio

About Karen (Kay) Gray

PhD Biomedical Sci. My goal is to continue in the pharmaceutical and diagnostic industries. My experiences range from discovery research [oncology & endocrinology], medical and clinical affairs activities, design of PD strategy for clinical protocols, companion diagnostics, central/reference laboratory contracts, and promotion of my company's drug pipelines or test platforms with KOLs. I have a wholesome view of biology and pathobiology from the molecular level to the whole organism. Harnessing this education allows me to focus on the areas that have the greatest medical impact. I know how to manage the risk by establishing Go/NoGo points in quick ‘POC' studies, and if there is failure, then new directions/ideas can be tested. I have learned to avoid blind application of complex molecular profiles, which can siphon valuable resources and delay timelines and clinical trials. Success requires judicious application of resources and rigorous acceptance criteria selecting only those candidates with the highest probability of success and fall within the business portfolio. I have a firm understanding of the potential role that biomarkers will play in healthcare and I know the business implications and risks of identifying and using diagnostic tests to tailor drugs or regimens to optimally treat a patient. Know the test limitations, use caution against over-reliance on one ‘surrogate’, and determine if the test is ‘value added’ to current standard of care. In summary, I have the skills to set up focused programs to provide knowledge to support rational, scientific based development for targeted therapeutics, biomarkers, and diagnostics.Specialties: Pharmaceutical and Diagnostics. Translational Medicine Discovery to Clinic, Biomarkers, Molecular Pathology, Target Validation, Medical and Clinical Affairs

Current workplace

Karen (Kay) Gray's current company

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Exelixis, Inc.
Exelixis, Inc.
Translational Medicine: Pharmaceuticals and Diagnostics Professional
alameda, california, united states
Website
Employees
863
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5 roles

Karen (Kay) Gray work experience

A career timeline built from the work history available for this profile.

Associate Director Translational Medicine

Current

Direct drug specific pharmacodynamic (PD) biomarker assessment of kinase inhibitors in oncology clinical trials. Manage clinical specimen repository, translational medicine representative on drug specific clinical studies Phase I – Phase III, set up molecular and histopathology services to support identification of correlative oncology PD biomarkers, coordinate executive discussions with Diagnostic Companies for co-development of companion diagnostic tests with drugs, and write biospecimen collection manuals, clinical protocols.

Aug 2007 - Present

Group Leader R&D Diagnostics

Veridex, Llc (A J&J Company)

Translational Science role from discovery to development to feasibility clinical research to clinical trial design supporting molecular diagnostic test development. · Responsible for the clinical repository and histopathology services to support assay development and clinical needs. · Manage clinical site implementation (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. · Medical Affairs responsibilities representing products. · Due Diligent assessment of Healthcare Information Networks.· Drafted ‘Key Opinion Leaders’ to support R&D.

Jun 2004 - Aug 2007

Manager Of Development & Lab Operations: Therapeutic Diagnostics Program

Pharmaco - Omics. Expand the reagent line by leading the development of molecular assays for specific drug targets or biomarkers to support pharmaceutical drug development programs. · Developed molecular pathology tests (IHC and ISH) for specific drug target and biomarkers to support the clinical trials of molecular targeted therapeutics (kinase pathways & cell surface targets) for pharmaceutical partners. · Participated in the assessment of the current and future needs for new biotechnologies in the molecular validation of targets and biomarkers, and assist in the design and implementation of ‘proof-of-concept’ studies.· Member of interdisciplinary teams to establish operational guidelines and policies for pharmaceutical collaborations and specific biomarker initiatives. · Scientific liaison traveling with business development team.· Oversaw lab operations, refine SOP’s, and ensure quality controls to support CLIA certification.

Apr 2003 - Jan 2004

Senior Scientist Ii, Molecular Pathology: Discovery Research & Development

Leader of oncology gene and protein target validation for small molecule and antibody drug development programs. · Established credentialing of target by relating gene/protein expression to known histopathological, growth, & differentiation parameters associated with diagnosis, prognosis, and toxicity. · Assessed new biotechnologies for molecular validation of targets & biomarkers, and designed the ‘proof-of-concept’ studies.· Prepared departmental budget, goals, and process improvement plans, and served as departmental liaison to the division executive team.· Member of interdisciplinary teams with a major role in establishing operational guidelines and policies for specific drug development and oncology personalized (biomarker) medicine. · Supervised and advised personnel on team and core technology groups.

May 2000 - Mar 2003

Senior Principal Investigator: Discovery Research & Development

Serono: Serono Reproductive Biology Institute

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.· Developed the 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.· 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.

May 1998 - Mar 2000
Team & coworkers

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2 education records

Karen (Kay) Gray education

Phd, Biomedical Sciences - Oncology

Oak Ridge Graduate School of Biomedical Sciences, ORNL, University of Tennessee, Oak Ridge, TN (Thesis: A Study of Protein Modifications.

Bs, Biology

Virginia Polytechnic Institute & SU, Blacksburg, Virginia (GPA 3.71)

FAQ

Frequently asked questions about Karen (Kay) Gray

Quick answers generated from the profile data available on this page.

What company does Karen (Kay) Gray work for?

Karen (Kay) Gray works for Exelixis, Inc..

What is Karen (Kay) Gray's role at Exelixis, Inc.?

Karen (Kay) Gray is listed as Translational Medicine: Pharmaceuticals and Diagnostics Professional at Exelixis, Inc..

What is Karen (Kay) Gray's email address?

AeroLeads has found 1 work email signal at @optonline.net for Karen (Kay) Gray at Exelixis, Inc..

Where is Karen (Kay) Gray based?

Karen (Kay) Gray is based in San Francisco, California, United States while working with Exelixis, Inc..

What companies has Karen (Kay) Gray worked for?

Karen (Kay) Gray has worked for Exelixis, Inc., Veridex, Llc (A J&J Company), Ventana Medical Systems, Inc, Millennium Pharmaceuticals, Inc, and Serono: Serono Reproductive Biology Institute.

Who are Karen (Kay) Gray's colleagues at Exelixis, Inc.?

Karen (Kay) Gray's colleagues at Exelixis, Inc. include Lance Piecoro, Lana Andrianova, Md, Mph, Patricia K. Behounek, Linh Phan, and Andreas Kaklios.

How can I contact Karen (Kay) Gray?

You can use AeroLeads to view verified contact signals for Karen (Kay) Gray at Exelixis, Inc., including work email, phone, and LinkedIn data when available.

What schools did Karen (Kay) Gray attend?

Karen (Kay) Gray holds Phd, Biomedical Sciences - Oncology from University Of Tennessee, Knoxville.

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