Jason Moore, MS, MBA, RAC

Vice President, Regulatory Affairs & Quality Assurance at Avillion LLP
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Park City, Utah, United States, US
Languages
  • Russian (requires renewal) -
Skills

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

5.0

/5.0
/ Based on 2 ratings
  • (2)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

Susan Grant Schneider, MPS

Jason's leadership and expertise as Vice President Clinical, Quality and Regulatory with PLx provided me with a client/partner that worked proactively in identifying solutions, collaborative in designing programs and ensured high caliber delivery on all aspects of clinical development we worked on. A true pleasure to work with!

Scott Terry

I am honored to have been able to work with Jason. He helped me tremendously when I needed an expert on quality operations within a pharmaceutical facility. Not only is he extremely knowledgeable, he is a very good communicator as well, both written and verbal. The curriculum deliverable he produced for me was outstanding! He is at the top of my list when I need a subject matter expert. Plus he is an all around great guy who has been on some great adventures - I live vicariously through him.

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Regulatory Affairs Certification (RAC) - Global
    Regulatory Affairs Professional Society
    Dec, 2014
    - Oct, 2024
  • Regulatory Affairs Certification (RAC) - US
    Regulatory Affairs Professional Society
    Dec, 2010
    - Oct, 2024

Experience

  • Avillion LLP
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Vice President, Regulatory Affairs & Quality Assurance
      • Jan 2021 - Present

      US-based regulatory and quality assurance leader with responsibility for integrated strategic regulatory planning and execution across all programs globally, as well as overseeing all aspects of the company's Quality Management System. US-based regulatory and quality assurance leader with responsibility for integrated strategic regulatory planning and execution across all programs globally, as well as overseeing all aspects of the company's Quality Management System.

  • JEM Biopharma Consulting, LLC
    • Principal Consultant, Regulatory Affairs, Clinical, Quality & Compliance, and Medical Writing
      • Feb 2018 - Dec 2020

      Provide a range of regulatory affairs, drug development, clinical, quality & compliance, and medical writing services. Focus on integration of development strategy with commercial needs, to enhance value at time of product launch, through nuanced target-product profiling and integrated development planning. Provide seminars/instructional programs on such topics as GCP; strategic communications in regulatory submissions; managing and responding to FDA 483s and Warning Letters; high-performance… Show more Provide a range of regulatory affairs, drug development, clinical, quality & compliance, and medical writing services. Focus on integration of development strategy with commercial needs, to enhance value at time of product launch, through nuanced target-product profiling and integrated development planning. Provide seminars/instructional programs on such topics as GCP; strategic communications in regulatory submissions; managing and responding to FDA 483s and Warning Letters; high-performance project management for biopharma project teams; and strategic product portfolio management. Show less Provide a range of regulatory affairs, drug development, clinical, quality & compliance, and medical writing services. Focus on integration of development strategy with commercial needs, to enhance value at time of product launch, through nuanced target-product profiling and integrated development planning. Provide seminars/instructional programs on such topics as GCP; strategic communications in regulatory submissions; managing and responding to FDA 483s and Warning Letters; high-performance… Show more Provide a range of regulatory affairs, drug development, clinical, quality & compliance, and medical writing services. Focus on integration of development strategy with commercial needs, to enhance value at time of product launch, through nuanced target-product profiling and integrated development planning. Provide seminars/instructional programs on such topics as GCP; strategic communications in regulatory submissions; managing and responding to FDA 483s and Warning Letters; high-performance project management for biopharma project teams; and strategic product portfolio management. Show less

  • Camargo Pharmaceutical Services
    • Vice President, Global Program Management
      • Feb 2015 - Nov 2017

      Camargo Pharmaceutical Services increases speed-to-market for pharmaceutical clients in the U.S. and abroad. As their strategic outsourcing partner, Camargo provides efficient, cost-effective comprehensive drug product development, clinical program development and regulatory services for Phases I-IV. Team Camargo members have realized over 150 FDA approvals for ANDA's and NDAs, both 505(b)(1)s and 505(b)(2)s, in a wide range of therapeutic areas. As Vice President, Global Program… Show more Camargo Pharmaceutical Services increases speed-to-market for pharmaceutical clients in the U.S. and abroad. As their strategic outsourcing partner, Camargo provides efficient, cost-effective comprehensive drug product development, clinical program development and regulatory services for Phases I-IV. Team Camargo members have realized over 150 FDA approvals for ANDA's and NDAs, both 505(b)(1)s and 505(b)(2)s, in a wide range of therapeutic areas. As Vice President, Global Program Management, facilitated the use of comprehensive project management methodologies across Camargo’s constellation of client programs, with an emphasis on rapid, cost-effective, risk-balanced, and successful execution. Oversaw the Program Management Office, Clinical Affairs, and Medical Writing, selected Quality/Compliance activities, and led major, enterprise-wide change initiatives encompassing infrastructure, process maturation, and training. As member of the senior leadership team, shaped organizational development through focused contributions to legal, human resources, IT, and compliance activities. Show less Camargo Pharmaceutical Services increases speed-to-market for pharmaceutical clients in the U.S. and abroad. As their strategic outsourcing partner, Camargo provides efficient, cost-effective comprehensive drug product development, clinical program development and regulatory services for Phases I-IV. Team Camargo members have realized over 150 FDA approvals for ANDA's and NDAs, both 505(b)(1)s and 505(b)(2)s, in a wide range of therapeutic areas. As Vice President, Global Program… Show more Camargo Pharmaceutical Services increases speed-to-market for pharmaceutical clients in the U.S. and abroad. As their strategic outsourcing partner, Camargo provides efficient, cost-effective comprehensive drug product development, clinical program development and regulatory services for Phases I-IV. Team Camargo members have realized over 150 FDA approvals for ANDA's and NDAs, both 505(b)(1)s and 505(b)(2)s, in a wide range of therapeutic areas. As Vice President, Global Program Management, facilitated the use of comprehensive project management methodologies across Camargo’s constellation of client programs, with an emphasis on rapid, cost-effective, risk-balanced, and successful execution. Oversaw the Program Management Office, Clinical Affairs, and Medical Writing, selected Quality/Compliance activities, and led major, enterprise-wide change initiatives encompassing infrastructure, process maturation, and training. As member of the senior leadership team, shaped organizational development through focused contributions to legal, human resources, IT, and compliance activities. Show less

  • PLx Pharma LLC
    • Vice President, Clinical, Quality, and Regulatory Affairs
      • 2007 - Dec 2014

      • Led all regulatory affairs functions, including both strategic and operational facets of RA. Provided comprehensive regulatory analyses of strategic development options and Agency positions. Led all company-FDA meetings/negotiations and managed all interactions with the Agency. • Responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA; led multidisciplinary teams to generate, review, and publish submissions. • Direct “in-the-trenches” experience with… Show more • Led all regulatory affairs functions, including both strategic and operational facets of RA. Provided comprehensive regulatory analyses of strategic development options and Agency positions. Led all company-FDA meetings/negotiations and managed all interactions with the Agency. • Responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA; led multidisciplinary teams to generate, review, and publish submissions. • Direct “in-the-trenches” experience with multiple eCTD platforms and dozens of electronic submissions, including the lead product eCTD NDA, which was approved in first review cycle. • Led all clinical trial operations, from contract negotiation and protocol development to final study report, including work with CROs, domestic and international clinical sites, investigators and opinion leaders, and the integrated study team. High success rate in achieving timeline/budget/quality expectations for complex trials of all phases. • Responsible for pharmacovigilance/SAE management/regulatory reporting programs. • Managed nonclinical studies, from contract negotiation to execution, reporting, evaluation of regulatory impact, and submission to regulatory agencies. • Managed selected CMO activities related to ongoing manufacturing and stability programs, as well as scale-up and process validation. • Administered successful federal grants programs, including the preparation of grant applications and managing active grant program (multiple NIH and DoD SBIR/STTR grants). Managed the company’s SRAs/CRADAs with multiple academic institutions. • Led quality, compliance, and audit activities, including internal Quality Systems, as well as CRO qualification, CMO and API supplier audits, investigations/CAPA, and risk management. • Managed significant number of consultants, thought leaders, and external contractors, including contract negotiation, performance/value, and deliverable reviews. Show less • Led all regulatory affairs functions, including both strategic and operational facets of RA. Provided comprehensive regulatory analyses of strategic development options and Agency positions. Led all company-FDA meetings/negotiations and managed all interactions with the Agency. • Responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA; led multidisciplinary teams to generate, review, and publish submissions. • Direct “in-the-trenches” experience with… Show more • Led all regulatory affairs functions, including both strategic and operational facets of RA. Provided comprehensive regulatory analyses of strategic development options and Agency positions. Led all company-FDA meetings/negotiations and managed all interactions with the Agency. • Responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA; led multidisciplinary teams to generate, review, and publish submissions. • Direct “in-the-trenches” experience with multiple eCTD platforms and dozens of electronic submissions, including the lead product eCTD NDA, which was approved in first review cycle. • Led all clinical trial operations, from contract negotiation and protocol development to final study report, including work with CROs, domestic and international clinical sites, investigators and opinion leaders, and the integrated study team. High success rate in achieving timeline/budget/quality expectations for complex trials of all phases. • Responsible for pharmacovigilance/SAE management/regulatory reporting programs. • Managed nonclinical studies, from contract negotiation to execution, reporting, evaluation of regulatory impact, and submission to regulatory agencies. • Managed selected CMO activities related to ongoing manufacturing and stability programs, as well as scale-up and process validation. • Administered successful federal grants programs, including the preparation of grant applications and managing active grant program (multiple NIH and DoD SBIR/STTR grants). Managed the company’s SRAs/CRADAs with multiple academic institutions. • Led quality, compliance, and audit activities, including internal Quality Systems, as well as CRO qualification, CMO and API supplier audits, investigations/CAPA, and risk management. • Managed significant number of consultants, thought leaders, and external contractors, including contract negotiation, performance/value, and deliverable reviews. Show less

  • BioHouston, Inc.
    • Director, Industry Programs
      • 2003 - 2007

      Director, Industry Programs • Responsible for a range of programs designed to increase Houston's momentum in life science technology commercialization and facilitate the maturation of the region as a life science economic cluster. • Developed and managed the BioHouston Partnering/Strategic Alliance program, an alliance “matchmaking” program with large pharmaceutical and biotech companies; managed similar program with non-regional venture capitalists. • Chaired/facilitated BioHouston… Show more Director, Industry Programs • Responsible for a range of programs designed to increase Houston's momentum in life science technology commercialization and facilitate the maturation of the region as a life science economic cluster. • Developed and managed the BioHouston Partnering/Strategic Alliance program, an alliance “matchmaking” program with large pharmaceutical and biotech companies; managed similar program with non-regional venture capitalists. • Chaired/facilitated BioHouston programs related to clinical/regulatory affairs, technology transfer, and human resources; served in multiple ad hoc advisory roles supporting life science companies, academic programs, and service providers in the Houston region. • Served on or contributed materially to regional and state initiatives fostering economic and life science cluster development, including the Governor’s Cluster Initiative (Biotechnology), the Texas Emerging Technology Fund, and the Houston Mayor’s Economic Development Task Force. • Spoke frequently on topics including BioHouston, the economic potential of life science technology commercialization, the biotech industry, regulatory matters, and others (see partial listing below). • Addressed scores of other BioHouston operational and strategic needs, including business planning, fundraising, internships, public policy advocacy, media interaction, key writing projects, and outreach. Manager, BioHouston Resource Center (simultaneous with role as Director, Industry Programs) • Managed all aspects of day-to-day operations of a wet-laboratory incubator facility for early-stage biotechnology companies, including identification of and negotiation with potential occupant companies, forecasting and budgeting, and contract management. • Completed the transition-to-operations of this facility, after managing the acquisition of the facility. Show less Director, Industry Programs • Responsible for a range of programs designed to increase Houston's momentum in life science technology commercialization and facilitate the maturation of the region as a life science economic cluster. • Developed and managed the BioHouston Partnering/Strategic Alliance program, an alliance “matchmaking” program with large pharmaceutical and biotech companies; managed similar program with non-regional venture capitalists. • Chaired/facilitated BioHouston… Show more Director, Industry Programs • Responsible for a range of programs designed to increase Houston's momentum in life science technology commercialization and facilitate the maturation of the region as a life science economic cluster. • Developed and managed the BioHouston Partnering/Strategic Alliance program, an alliance “matchmaking” program with large pharmaceutical and biotech companies; managed similar program with non-regional venture capitalists. • Chaired/facilitated BioHouston programs related to clinical/regulatory affairs, technology transfer, and human resources; served in multiple ad hoc advisory roles supporting life science companies, academic programs, and service providers in the Houston region. • Served on or contributed materially to regional and state initiatives fostering economic and life science cluster development, including the Governor’s Cluster Initiative (Biotechnology), the Texas Emerging Technology Fund, and the Houston Mayor’s Economic Development Task Force. • Spoke frequently on topics including BioHouston, the economic potential of life science technology commercialization, the biotech industry, regulatory matters, and others (see partial listing below). • Addressed scores of other BioHouston operational and strategic needs, including business planning, fundraising, internships, public policy advocacy, media interaction, key writing projects, and outreach. Manager, BioHouston Resource Center (simultaneous with role as Director, Industry Programs) • Managed all aspects of day-to-day operations of a wet-laboratory incubator facility for early-stage biotechnology companies, including identification of and negotiation with potential occupant companies, forecasting and budgeting, and contract management. • Completed the transition-to-operations of this facility, after managing the acquisition of the facility. Show less

  • Introgen Therapeutics, Inc.
    • Biotechnology Research
    • 1 - 100 Employee
    • Associate Director, Project Management
      • 2002 - 2003

      • Led a wide range of clinical and regulatory projects, including the management of major international clinical operations initiatives and the planning and production of major and minor regulatory submissions. • Facilitated the maturation of the project management systems employed by the company, and provided project management leadership to a range of product-development projects. • Led a wide range of clinical and regulatory projects, including the management of major international clinical operations initiatives and the planning and production of major and minor regulatory submissions. • Facilitated the maturation of the project management systems employed by the company, and provided project management leadership to a range of product-development projects.

  • Agenus
    • United States
    • Biotechnology Research
    • 200 - 300 Employee
    • Director, Business Analysis
      • 2000 - 2002

      • Successfully managed the merger integration of Aronex Pharmaceuticals and Agenus (then Antigenics), following Aronex’s acquisition, completing the integration ahead of schedule. • Following the merger, shaped strategy by providing quantitative and qualitative business-case and product-portfolio analyses in support of business development/licensing, investment decisions, and program management, using powerful financial modeling and market- and risk-assessment tools. • Analyzed markets… Show more • Successfully managed the merger integration of Aronex Pharmaceuticals and Agenus (then Antigenics), following Aronex’s acquisition, completing the integration ahead of schedule. • Following the merger, shaped strategy by providing quantitative and qualitative business-case and product-portfolio analyses in support of business development/licensing, investment decisions, and program management, using powerful financial modeling and market- and risk-assessment tools. • Analyzed markets and competitors for multiple oncology and infectious disease indications, and completed comprehensive analyses of several of the company’s products within the respective markets/competitive environments. Show less • Successfully managed the merger integration of Aronex Pharmaceuticals and Agenus (then Antigenics), following Aronex’s acquisition, completing the integration ahead of schedule. • Following the merger, shaped strategy by providing quantitative and qualitative business-case and product-portfolio analyses in support of business development/licensing, investment decisions, and program management, using powerful financial modeling and market- and risk-assessment tools. • Analyzed markets… Show more • Successfully managed the merger integration of Aronex Pharmaceuticals and Agenus (then Antigenics), following Aronex’s acquisition, completing the integration ahead of schedule. • Following the merger, shaped strategy by providing quantitative and qualitative business-case and product-portfolio analyses in support of business development/licensing, investment decisions, and program management, using powerful financial modeling and market- and risk-assessment tools. • Analyzed markets and competitors for multiple oncology and infectious disease indications, and completed comprehensive analyses of several of the company’s products within the respective markets/competitive environments. Show less

  • Aronex Pharmaceuticals, Inc.
    • 1 - 100 Employee
    • Associate Director, Program Management
      • 1998 - 2000

      Associate Director, Program Management • Completed valuations of the company’s products, providing key information supporting merger and acquisition discussions following the restructuring of the company. • Implemented a Program Management Office, in continuation and extension of the introduction of project management systems to Aronex (as discussed under Project Manager). • Facilitated the maturation of the program management systems at Aronex, including the establishment of an… Show more Associate Director, Program Management • Completed valuations of the company’s products, providing key information supporting merger and acquisition discussions following the restructuring of the company. • Implemented a Program Management Office, in continuation and extension of the introduction of project management systems to Aronex (as discussed under Project Manager). • Facilitated the maturation of the program management systems at Aronex, including the establishment of an infrastructure and methodology to allow the systematic and comprehensive planning, execution, control, documentation, and reporting of the company’s projects. • Managed the company’s drug-development program, including the entire range of pharmaceutical, preclinical, clinical development, NDA submission, and pre-launch activities. • Developed a Target Product Profiling and Integrated Development Planning process, linking drug-development activities to regulatory requirements and the needs of the marketplace. • Established and chartered product-associated project teams, and developed formal contract management systems and standards. Project Manager • As Project Manager for a liposomal systemic antifungal agent, coordinated all aspects of the drug-development program, including clinical, bioanalytical, and pharmacokinetic studies, and the preparation of an NDA dossier. • Managed the relationship with Aronex’s corporate partner, Abbott Laboratories, relating to late clinical-development activities and planned submission of the Nyotran NDA. • Introduced Project Management as a discipline to Aronex, developing requisite infrastructure, and implementing processes and policies to speed product development, reduce cost, and enhance the quality of outputs. Medical Writer • Wrote and edited a wide range of regulatory and clinical documents associated with multiple oncology and infectious disease indications, and managed the ongoing writing activities of the company. Show less Associate Director, Program Management • Completed valuations of the company’s products, providing key information supporting merger and acquisition discussions following the restructuring of the company. • Implemented a Program Management Office, in continuation and extension of the introduction of project management systems to Aronex (as discussed under Project Manager). • Facilitated the maturation of the program management systems at Aronex, including the establishment of an… Show more Associate Director, Program Management • Completed valuations of the company’s products, providing key information supporting merger and acquisition discussions following the restructuring of the company. • Implemented a Program Management Office, in continuation and extension of the introduction of project management systems to Aronex (as discussed under Project Manager). • Facilitated the maturation of the program management systems at Aronex, including the establishment of an infrastructure and methodology to allow the systematic and comprehensive planning, execution, control, documentation, and reporting of the company’s projects. • Managed the company’s drug-development program, including the entire range of pharmaceutical, preclinical, clinical development, NDA submission, and pre-launch activities. • Developed a Target Product Profiling and Integrated Development Planning process, linking drug-development activities to regulatory requirements and the needs of the marketplace. • Established and chartered product-associated project teams, and developed formal contract management systems and standards. Project Manager • As Project Manager for a liposomal systemic antifungal agent, coordinated all aspects of the drug-development program, including clinical, bioanalytical, and pharmacokinetic studies, and the preparation of an NDA dossier. • Managed the relationship with Aronex’s corporate partner, Abbott Laboratories, relating to late clinical-development activities and planned submission of the Nyotran NDA. • Introduced Project Management as a discipline to Aronex, developing requisite infrastructure, and implementing processes and policies to speed product development, reduce cost, and enhance the quality of outputs. Medical Writer • Wrote and edited a wide range of regulatory and clinical documents associated with multiple oncology and infectious disease indications, and managed the ongoing writing activities of the company. Show less

  • Amgen
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Medical Writer
      • 1996 - 1996

      • Wrote and edited various documents for the Medical Writing Department, including journal articles, backgrounders, meeting summaries, and book chapters. • Wrote and edited various documents for the Medical Writing Department, including journal articles, backgrounders, meeting summaries, and book chapters.

Education

  • University of Houston, C.T. Bauer College of Business
    M.B.A., Business Administration
    2000 - 2001
  • Texas A&M University
    M.S., Science & Technology Journalism (Medical Writing)
    1995 - 1997
  • Texas A&M University
    B.A., Psychology
    1985 - 1990

Community

You need to have a working account to view this content. Click here to join now