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Companion Diagnostic (CDx) and Biomarker expert in developing end-to-end IVD co-development strategies for Oncology Immuno-Oncology, Rare Diseases, Gene, and Cell TherapyExperienced Manager with a proven ability to build effective, high performing teams. Successfully leads cross-functional and global project teams to meet key deliverables on time and with highest quality. Recognized for building strong relationships and productive collaborations between teams, departments, and sites.Highly proficient speaker with strong presentation skills.Areas of Expertise Include: • Companion Diagnostics (CDx) • IVD Co-Development Strategies• Biomarkers• Clinical Biomarker Strategies• Oncology Signaling Pathways• Early and Late Stage Clinical Trials• Precision Medicine• Molecular Diagnostics • Assay Development• Cross-Functional Team Leadership• Project Management • Developing Partnership Agreements for CDx• Developing and Leading Effective Teams in a Matrix Organization
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Principal Companion Diagnostics (Cdx) Development LeadGenentech Aug 2022 - PresentSouth San Francisco, California, Us• Develop and lead CDx and clinical diagnostic enrollment and filing strategies for therapeutic programs across oncology, gene therapy, and autoimmune disease areas• Enable worldwide diagnostic solutions across US/EU/China/Japan and collaborate with Commercial to develop forward-looking strategies that enable broad access to high-quality diagnostic testing at launch -
Director, Biomarker SciencesSangamo Therapeutics, Inc. Jun 2020 - Oct 2022Brisbane, California, Us• Develop and implement Biomarker Strategy for early through late phase programs in Gene and Cell Therapy• Lead CDx development for late-stage assets, including CDx strategy, partner selection, and execution -
Associate Director, Companion DiagnosticsAbbvie Apr 2018 - May 2020North Chicago, Illinois, Us• Develop and implement CDx and clinical biomarker strategy• Select CDx technology, CDx partner, and oversee implementation of CDx Assay into Clinical Protocols and Trials• Responsible for CDx co-approval with drug candidate and supporting BLA/PMA submissions• Lead the clinical characterization of the diagnostic biomarker and the selected patient population • Represent the CDx Function on global AbbVie project teams -
Project Manager, Companion DiagnosticsAgilent Technologies Dec 2015 - Apr 2018Santa Clara, Ca, Us• Lead global, multi-site, cross-functional teams in Companion In Vitro Diagnostic (CDx) development and successful PMA submissions for co-filing with Immuno-Oncology therapeutics• Create and manage resource forecast plan, work plan, and budget for projects ranging from $12M to $60M in collaboration with Tier 1 Pharma Partners• Define major milestones and identify key risks impacting device development, validation, design transfer, PMA submission, clinical product inventory and logistics, and commercial launch• Build and maintain relationships between pharmaceutical clients and key functional areas including Clinical, Regulatory, Marketing, Business Development, R&D, Operations, and Commercial• Influence internal and external stakeholders at all levels in a matrixed team environment resulting in positive outcomes -
Senior Scientist And Team LeaderGenoptix Medical Laboratory, A Novartis Company Dec 2012 - Sep 2015Carlsbad, California, Us• Managed direct reports and guided activities of Molecular Assay team • Developed and validated biomarker-based assays (LDTs) in a CLIA-compliant environment for use in Phase I – III oncology clinical trials• Managed and executed assay development and transfer to clinical production for multiple projects concurrently; provided scientific oversight throughout duration of trial• Collaborated across departments and served as a consultant to provide scientific expertise on project execution and design• Designed curriculum and instructed for in-house Clinical Laboratory Scientist (CLS) training program in areas of molecular testing and diagnostics -
Senior Development Scientist And Technical LeadBeckman Coulter Sep 2010 - Nov 2012Brea, California, Us• Lead a team of 6 BS/MS/PhD level scientists to develop multiplexed qPCR assays for IVD use in infectious disease • Define and implement strategy for assay design, optimization and validation• Responsible for all aspects of assay development, including targeting strategy, primer design, optimization and validation • Design, execute, and analyze DOEs for assay optimization -
Afpe Endowed Pre-Doctoral FellowUniversity Of Arizona Aug 2006 - Jun 2007Tucson, Arizona, Us -
Associate ScientistPfizer Feb 2002 - Jun 2004New York, New York, Us• Strategized with discovery department and preclinical development group to provide early identification of barriers to successful drug delivery.
Katherine Block, Phd, Pmp Skills
Katherine Block, Phd, Pmp Education Details
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University Of ArizonaCancer Biology) -
University Of Missouri-Saint LouisChemistry
Frequently Asked Questions about Katherine Block, Phd, Pmp
What company does Katherine Block, Phd, Pmp work for?
Katherine Block, Phd, Pmp works for Genentech
What is Katherine Block, Phd, Pmp's role at the current company?
Katherine Block, Phd, Pmp's current role is Principal CDx Lead at Genentech.
What is Katherine Block, Phd, Pmp's email address?
Katherine Block, Phd, Pmp's email address is ka****@****vie.com
What is Katherine Block, Phd, Pmp's direct phone number?
Katherine Block, Phd, Pmp's direct phone number is +176051*****
What schools did Katherine Block, Phd, Pmp attend?
Katherine Block, Phd, Pmp attended University Of Arizona, University Of Missouri-Saint Louis.
What skills is Katherine Block, Phd, Pmp known for?
Katherine Block, Phd, Pmp has skills like Assay Development, Molecular Biology, Biochemistry, Fluorescence, Cell, Life Sciences, Cell Signaling, Protein Chemistry, Pcr, Cell Culture, Biomarkers, Purification.
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