Michelle Gearhart, PharmD
Loveland
Summary
Experienced leader in Medical and Scientific Affairs with Research and Development expertise.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Vice President of Medical Affairs
Cleerly Health
10.2024 - Current
- Lead data generation and data dissemination strategy and execution for the organization
- Implement scientific communications and content development
- Collaborate with cross functional partners on organization strategy and priorities
- Lead scientific advocacy and access strategy
- Overseeing the creation of medical content for diverse platforms like Social Media, Webex's, Courses, brochures, press releases, and other promotional materials.
Organizing and directing medical education events and conferences - Develop and implement professional education programs such as speaker bureau and round table in collaboration with Marketing
- Ensuring healthcare professionals are informed about the latest advancements and best practices related to Cleerly's AI based digital care platform
Head of Scientific Affairs
Esperion Therapeutics
08.2022 - 09.2024
- Leads the global scientific and medical affairs functions for investigational and marketed products
- Responsible for data generation strategy, including real world evidence generation, clinical studies, collaborative and investigator initiated studies.
- Oversees grant and continuing medical education funding and compliance.
- Member of the label negotiation committee and launch excellence leader.
- Leads development of systems and processes to ensure harmonized and integrated medical affairs function that will be executed in compliance with applicable laws, regulations, and company policies
- Oversee and drive and publication strategy and execution and review potential manuscripts/abstracts and congress planning
- Develop strategic architecture and directly manage relationships with Key Opinion Leaders (KOLs), medical societies, advocacy groups and other key stakeholders
- Manage scientific and medical affairs budget and will be responsible for optimal resource allocation
- Joint Company Alliance manager and committee member with all partners.
Head of Medical Affairs
Better Therapeutics
10.2021 - 08.2022
- Responsible for all data generation and dissemination activities
- Lead and execute all Real World Evidence Studies
- Lead all study teams
- Develop enrollment and recruitment efforts
- Maintain study guidelines and communicate all milestones
- Lead Data and Safety Monitoring Board
- Create the Scientific Platform to guide all internal and external communications and education
- Develop and execute a comprehensive publication plan that engages all stakeholders and audiences
- Generate an extensive Medical Congress and Society engagement plan
- Lead CME and Non-CME Educational Symposium planning and execution
- Build strong networks of key opinion leaders and patient advocacy groups
- Engage payer and population health decision makers to develop budget impact model and cost offset analysis to obtain favorable coverage decisions.
Director of Strategy and Execution - Neuropsychology
Global Medical Affairs - Johnson & Johnson
03.2021 - 10.2021
- Execute on key GMA projects for Neuropsychiatry Therapeutic Area
- Development and execution of GCSO funded medical strategies
- Manage budget, vendors, and programs for identified projects
- Support IEGP development
- Publication Planning
- Maintain Global Psychiatry Budget/Financials, Business Plan, and Contracts for all MAF activities
- Lead the budget planning with the Psychiatry MAF team for yearly business planning
- Maintain Psychiatry budget/finances on track
- Lead compliance reviews (Totality) and execute contracts.
Global Feasibility Lead- Oncology
Janssen Research & Development - Johnson & Johnson
03.2019 - 03.2021
- Led and Developed Janssen Feasibility Center of Excellence Standard Operating Procedure for Country and Site selection across all therapeutic areas
- Facilitates/leads feasibility activities across functions involved working closely with the Clinical and Operational leads to design and present recommendations to study team leads within defined guidelines
- Partner with study team members, country teams, and the feasibility insights and data analytics team to design and conduct global feasibility activities on time with high-quality delivery
- Leverage and effectively communicate key feasibility insights to influence and inform protocol development, study guidelines, operational plans, country, and site selection and help inform recruitment and patient recruitment strategies.
Director of Strategy and Operations - Johnson & Johnson
Value & Evidence Team
10.2017 - 03.2019
- Led the Scientific Communications Team, both in-house and remote direct reports, supporting all therapeutic areas in translating and creating the content to convey real-world evidence to the payer and IDN customer segment by the Field-Based Medical Team
- Worked closely with the data generation teams across all therapeutic areas to ensure appropriate data dissemination efficiently and effectively
- Developed Market Access Strategy for all launch compounds 12 months ahead of launch
- Developed Process for Evidence and Access communication tool for all compounds six months before launch
- Developed Data Dissemination Process for all pivotal trial data across all therapeutic areas.
Cardiovascular Life Cycle Management Integrated Evidence Team Leader
Janssen Medical Affairs - Johnson & Johnson
02.2015 - 10.2017
- Lead cross-functional Integrated Evidence Team (IET) composed of the TAL, medical directors, V&E team, SCL, CDTL, and other stakeholders
- Partnered with cross-functional IET members to identify and address evidence needs for value-based research and dissemination of data
- Developed and maintained an up-to-date Integrated Evidence Generation Plan (IEGP), or medical affairs strategy plan, to meet these evidence needs
- Updated the IEGP as needed based on emerging data or evolution of the therapeutic landscape
- Served as the key point person for the data generation, translation, and dissemination strategy initiatives in the IEPG
- Lead IET and IEGP-related workstreams and meetings
- Collaborated with the TAL, medical directors, V&E team, SCL, and other stakeholders on the overall strategic direction and execution of projects; and partnered with the Scientific Communications Lead to develop and update strategic publication and scientific communications plans
- Developed Xarelto Publication strategy based upon scientific need in the LCM Indications and company priorities
- Identify audiences and medical congresses that rivaroxaban data would be beneficial to encourage safe and appropriate use
- Lead Strategy and Tactics for Data Generation, Knowledge Translation, and Data Dissemination in the LCM areas of focus for Xarelto.
Principal Medical Science Liaison/ Xarelto Publication Team
Janssen Medical Affairs - Johnson & Johnson
09.2012 - 02.2015
- Participation on US and Global Publication teams
- Primary focus US Publication Strategy
- Identify audiences and medical congresses that rivaroxaban data would be beneficial to encourage safe and appropriate use
- Author support and collaboration
- Company liaison for authors
Senior Medical Project Scientist (MPS) - CVIM (cardiovascular-internal Medicine), Medical Affairs
Janssen Medical Affairs - Johnson & Johnson
01.2011 - 09.2012
- Engage in efficient, effective, and qualitative scientific exchange with customers
- Work in conjunction with the medical affairs and clinical development teams to evaluate potential external clinical research collaboration opportunities and facilitate the conduct of all external clinical Company-sponsored trials
- Participate on the publication team to review abstracts, posters, and manuscripts, identify authors and determine continued scientific/data gaps that need to be addressed via publications
- Earned Encore award for developing the training for Field-based Medical Affairs on Acute Coronary Syndrome
Senior Medical Science Liaison (MSL) - CVIM (cardiovascular-internal Medicine), Scientific Affairs
Ortho-McNeil Janssen Scientific Affairs, LLC - Johnson & Johnson
10.2007 - 01.2011
- Developed Cardiovascular Training Curriculum for Field-based Medical Affairs Personnel; this included presenting and overseeing other presentations
- Received Encore award for Training program
- Received two Encore awards for mentoring
- Onboarding Specialist and Training Lead for new hires.
Critical Care Clinical Pharmacist/University of Cincinnati College of Pharmacy/Regional Experiential Program Director, Ohio Northern University College of Pharmacy
University of Cincinnati Medical Center
06.2000 - 10.2007
- University Hospital Responsibilities: SICU / MICU / CICU / Burn Unit / Transplant Unit Patient Care Rounds
- SICU / MICU and Emergency Medicine Clinical Rotation Preceptor for Pharmacy Practice, Primary Care, and Critical Care Residents
- University of Cincinnati College of Pharmacy Adjunct Faculty
- Policy and guideline development and maintenance
- Reviewer for Institutional Review Board protocols
- University of Cincinnati Medical Center Committees: Inpatient Diabetes Management Team
- Pharmacy Residency Committee
- Medical ICU Total Quality Improvement Committee
- Adult Cystic Fibrosis Committee
- Surgical ICU Total Quality Improvement Committee
- Emergency Department Operations Committee
- University of Cincinnati College of Pharmacy Responsibilities: SICU / MICU / Emergency Medicine Clinical Rotation Preceptor for Doctor of Pharmacy students
- Clinical research activities
- Ohio Northern University College of Pharmacy Responsibilities: Regional Director of Experiential Programs
- Preceptor for NICU/ SICU / MICU / Emergency Medicine/ Hospital Pharmacy Clinical Rotation Doctor of Pharmacy students
Education
ASHP accredited Critical Care Residency -
University of Cincinnati Medical Center
ASHP accredited Pharmacy Practice Residency -
University of Cincinnati Medical Center
Doctor of Pharmacy -
Ohio Northern University
Skills
- Data generation and dissemination strategy
- Medical and Scientific Affairs Leadership
- Clinical trial feasibility and enrollment diversity
- KOL and DOL Engagement and Education
Leadership Training
- Medical & Scientific Affairs Management Development Program (MSA-MDP), 11/2016
- First Line Leaders, 09/2016
- Smith College for Women Leadership Program, 05/2014
Publications
- Frank Peacock, MD, Michelle Gearhart, PharmD, Roger Mills, MD, Emergency Management of Bleeding Associated With Old and New Oral Anticoagulants, Clinical Cardiology, 2012
- Gearhart MM, Parbhoo SK, Hyperglycemia in the Critically Ill Patient, AACN Clinical Issues, February, 2006
- Michelle Gearhart, PharmD Dave Wetzel R.Ph, PharmD Candidate, Alex Machen PharmD Candidate, Jill Martin PharmD, Joseph Solomkin MD, Joseph Buell MD, Vancomycin-resistant Enterococcus in Liver Transplant Patients, A Matched Control Study, Pending Publication in Clinical Transplantation
- Pass SE, Gearhart MM, Young EJ, Short-Course Antimicrobial Therapy for the Treatment of Pneumonia, Journal of Pharmacy Practice, 18, 1, 18-24, 2005
- Kim J, Gearhart MM, Zurick A, Zuccarello M, James L, Lucheoe FA, Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury, Journal of Trauma, 53, 1, 38-43, 2002
- Gearhart M, Lucheoe FA, Ooaway M, Davis K, Jr., Hurst JM, Johannigman JA, Fram SB, The risk assessment profile (RAP) identifies trauma patients at risk for deep vein thrombosis, Surgery, 128, 4, 631-40, 2000
- Knecht KT, Beckstead MJ, Sharp AL, Power MM, Rowe TA, Kimble CA, Carbon Tetrachloride (CCl4) Elimination in Mice Measured By a Simple Breath Analysis, Toxicologist, 30, 1940, 1996
Certification
Ohio Board of Pharmacy, 1998 - present
Timeline
Vice President of Medical Affairs
Cleerly Health
10.2024 - Current
Head of Scientific Affairs
Esperion Therapeutics
08.2022 - 09.2024
Head of Medical Affairs
Better Therapeutics
10.2021 - 08.2022
Director of Strategy and Execution - Neuropsychology
Global Medical Affairs - Johnson & Johnson
03.2021 - 10.2021
Global Feasibility Lead- Oncology
Janssen Research & Development - Johnson & Johnson
03.2019 - 03.2021
Director of Strategy and Operations - Johnson & Johnson
Value & Evidence Team
10.2017 - 03.2019
Cardiovascular Life Cycle Management Integrated Evidence Team Leader
Janssen Medical Affairs - Johnson & Johnson
02.2015 - 10.2017
Principal Medical Science Liaison/ Xarelto Publication Team
Janssen Medical Affairs - Johnson & Johnson
09.2012 - 02.2015
Senior Medical Project Scientist (MPS) - CVIM (cardiovascular-internal Medicine), Medical Affairs
Janssen Medical Affairs - Johnson & Johnson
01.2011 - 09.2012
Senior Medical Science Liaison (MSL) - CVIM (cardiovascular-internal Medicine), Scientific Affairs
Ortho-McNeil Janssen Scientific Affairs, LLC - Johnson & Johnson
10.2007 - 01.2011
Critical Care Clinical Pharmacist/University of Cincinnati College of Pharmacy/Regional Experiential Program Director, Ohio Northern University College of Pharmacy
University of Cincinnati Medical Center
06.2000 - 10.2007
ASHP accredited Pharmacy Practice Residency -
University of Cincinnati Medical Center
Doctor of Pharmacy -
Ohio Northern University
ASHP accredited Critical Care Residency -
University of Cincinnati Medical Center
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