Executive Medical Affairs Leader & Clinical Pharmacologist
Enterprise Biopharma Leadership: Seasoned Medical Affairs executive trusted by executive leadership to govern critical assets, shape scientific strategy, and deliver enterprise-wide results.
Startup Agility & Commercialization: Extensive experience driving early-stage and mid-sized biopharma through pivotal research-to-commercial inflection points and competitive market launches.
Transformational Change Agent: Known for stepping into high-friction environments to rebuild infrastructures, realign cross-functional teams, and turn complex organizational mandates into clear execution paths.
Execution & Ownership: Grounded in a hands-on, deliverable-first ethos—operating without functional silos, breaking through corporate bottlenecks, and doing whatever the mission requires to see critical objectives across the finish line.
Chair, Medical Review Committee▾ Hover or tap to expand
Madrigal Pharmaceuticals (May 2022 – Jan 2025). As Medical Director, held executive authority approving all medical, scientific, and commercial content at launch, directing cross-functional compliance and regulatory alignment.
Academic Steering Committee Governance▾ Hover or tap to expand
Established, structured, and governed multi-institution academic steering committees and clinical investigator consortia across Madrigal, Baudax Bio, Calliditas Therapeutics (Nefecon), and Allena Pharmaceuticals (URIROX-2).
Statewide President & Board of Directors▾ Hover or tap to expand
New York State Council of Health-System Pharmacists (NYSCHP). Elected Board Member (1999–2004), President of the Council & House of Delegates (2005–2006).
COVID-19 Vaccine Mobilization & Task Force▾ Hover or tap to expand
Executive leadership and strategic advisory with NYSDOH and regional health authorities governing pharmacist immunizer deployment, vaccination hubs, and emergency clinical operations.
National Public Policy Committees▾ Hover or tap to expand
American College of Clinical Pharmacology (ACCP, 2008–Present) & American College of Clinical Pharmacy (2008–2010).
VP of Governmental Affairs & Legislative Chair▾ Hover or tap to expand
NYSCHP (1999–2004). Authored and advanced landmark NY State legislation for Pharmacist Immunization Scope and Collaborative Drug Therapy Management (CDTM).
Scientific Advisory Board▾ Hover or tap to expand
Accreditation Council for Medical Affairs (ACMA, 2017–2018).
Highlights & Honors
Fellow, ACCP (FCP, 2009)▾ Hover or tap to expand
American College of Clinical Pharmacology. Highest professional fellowship awarded for distinguished contributions to clinical pharmacology.
Fellow, ASHP (FASHP, 2004)▾ Hover or tap to expand
American Society of Health-System Pharmacists. Elected Fellow recognized for career-long excellence in pharmacy practice and health-system leadership.
Madrigal Symphony Award (2024)▾ Hover or tap to expand
Executive recognition for cross-functional organizational excellence and medical affairs leadership.
Nitric Oxide Delivery System (Orange Book Listed)▾ Hover or tap to expand
FDA Orange Book-listed patent for Drug-Device Monitoring and Delivery System (US Patent US20130118486 A1 / Ikaria).
Neonatal Diagnostics Patent▾ Hover or tap to expand
Bronchopulmonary Dysplasia Diagnostic and Treatment Method (US Patent US20170212133 A1).
Education & Credentials
Pharm.D. (1993)Saint John's University, NY
B.S. Pharmacy (1991)Albany College of Pharmacy
Executive Management in Pharma Certificate (2011)Rutgers University
Pharmacoeconomics Certificate Program (2000)Harvard School of Public Health
Madrigal PharmaceuticalsMay 2022 – Present
Executive Global Medical Director, Medical Affairs
▾ Hover or tap to expand achievements
Governance & Commercial Launch Oversight: Served as Chair of the Medical Review Committee (MRC) from inception through January 2025; as Medical Director, held executive authority approving all medical and commercial launch content.
Academic Steering Committees: Established and governed external Academic Steering Committees and clinical investigator panels supporting late-stage evidence generation in liver disease.
Lead HEOR and real-world clinical outcome programs evaluating progression and complications in MASH and NASH populations.
Author high-impact publications analyzing disease trajectories across major Medicare longitudinal cohorts.
Executive oversight and strategic direction for enterprise medical affairs information resources and clinician non-invasive testing (NIT) education platforms.
Recipient of the 2024 Madrigal Symphony Award for cross-functional organizational excellence.
Held executive leadership across Medical Affairs functional groups for hospital and acute-care portfolios through corporate reorganization.
Instituted and governed external Academic Steering Committees and expert advisory panels for acute pain and hospital critical-care assets.
Calliditas TherapeuticsJan 2020 – Apr 2021
Executive Director and Head of US Medical Affairs
▾ Hover or tap to expand achievements
Established US Medical Affairs infrastructure, national MSL alignment, KOL advocacy strategies, and scientific platform policies.
Formed and governed the external Academic Steering Committee for Nefecon, orchestrating top nephrology investigators and key opinion leaders across the US.
Directed scientific narrative, medical communications, and Mechanism of Action (MOA) / Mechanism of Disease educational video assets for Nefecon in primary IgA nephropathy.
Directed medical affairs strategy, clinical data dissemination, and key opinion leader engagement in rare metabolic and nephrologic disorders through Phase 3 readout.
Established and governed the Academic Steering Committee for the landmark URIROX-2 clinical trial program, aligning global trial investigators and academic clinical experts.
scPharmaceuticalsMay 2017 – Mar 2019
Senior Director of Medical Affairs
▾ Hover or tap to expand achievements
Spearheaded health-economic evaluation models demonstrating Medicare cost savings by transitioning worsening heart failure to outpatient delivery.
Led the landmark FreEDom-HF clinical study initiative and associated peer-reviewed publications.
Authored and presented the multimedia video abstract explainer accompanying the CEOR Medicare heart failure cost-offset analysis.
Directed medical affairs readiness, scientific exchange, and advisory boards supporting late-stage novel antibiotic development.
Vanda PharmaceuticalsJan 2014 – Mar 2016
Director, Medical Affairs Strategy, MSLs and Global Health Outcomes
▾ Hover or tap to expand achievements
Directed strategic launch programs for Hetlioz® across US and German markets; established clinical registry for Smith-Magenis Syndrome.
IkariaJun 2009 – Jan 2014
Manager of Field Medical Affairs
▾ Hover or tap to expand achievements
Led hospital critical-care MSL teams; co-invented multiple patents for drug-device delivery and neonatal diagnostic monitoring systems.
Reliant Pharmaceuticals / GlaxoSmithKlineMay 2006 – Jun 2009
Senior Regional Medical Scientist II
▾ Hover or tap to expand achievements
Served at Reliant Pharmaceuticals prior to corporate acquisition by GSK; directed regional scientific exchange and cardiovascular KOL advocacy.
SUNY Upstate Medical University1994 – Present
Faculty Appointments | Department of Pharmacology & College of Medicine
▾ Hover or tap to expand achievements
Department of Pharmacology: Research Assistant Professor (2026 – Present), engaging in translational pharmacology research, grant advisory, and institutional candidate review.
Division of General Medicine (Section of Clinical Pharmacology): Associate Professor of Medicine (2003–2006) and Assistant Professor of Medicine (1998–2003).
School of Nursing & Regional Colleges: Assistant Professor of Nursing (1999–2006); Adjunct Associate Professor at Albany College of Pharmacy (1993–2006); Adjunct Assistant Professor at Wilkes University Nesbitt School of Pharmacy (2001–2006).
Delivered core didactic and bedside pharmacology curriculum to 2nd- and 4th-year medical students, critical care fellows, and graduate nurse practitioner candidates.
University Hospital, Syracuse, New YorkJun 1993 – May 2006
Associate Director of Pharmacy | Director of Pharmacy Services | Critical Care Specialist
▾ Hover or tap to expand achievements
Founded and directed the Inpatient Clinical Pharmacology Consult Service and Research Services.
Program Initiator and Director for ASHP-accredited Pharmacy Practice Residency, training and supervising 20+ specialized clinical residents and fellows.
Co-author of the official ASHP statement on the roles and responsibilities of the pharmacy executive (Am J Health Syst Pharm. 2009).
Oversaw health-system pharmacy operations, P&T Committee formulary governance, and investigational drug trials.
Selected Strategic Initiatives
Enterprise-level medical affairs platforms, scientific communications, and diagnostic educational hubs directed and sponsored under executive leadership to advance scientific exchange and clinical decision-making.
Medical Affairs & Scientific Exchange
Madrigal Medical Affairs Portal
Enterprise scientific and clinical resource center directed under Medical Affairs leadership for healthcare professionals, clinical investigators, and medical societies seeking scientific inquiries and evidence.
Medical Information Requests & direct scientific exchange for healthcare professionals
Clinical trial evidence, medical congress presentations, and peer-reviewed publications library
Disease-state educational resources in metabolic dysfunction-associated steatohepatitis (MASH)
Compliant Medical Affairs governance, scientific communications, and investigator relations
Strategically directed clinician educational platform dedicated to Non-Invasive Tests (NITs) in liver disease, supporting early risk assessment, staging, and longitudinal monitoring of liver fibrosis.
Nefecon (Calliditas) | Mechanism of Action & Disease Educational Animation
Strategically directed scientific animation and healthcare professional educational asset illustrating the mucosal gut-kidney axis and targeted release formulation in primary IgA nephropathy.
Comprehensive 3D scientific visualization detailing gut mucosal immune response and galactose-deficient IgA1 targeting
Translates complex mucosal immunology and targeted delivery mechanics for clinical investigators and nephrologists
Cornerstone scientific communication asset directed to anchor global scientific exchange and US medical launch readiness
Medicare Cost Impact in Worsening Heart Failure | Video Abstract & Manuscript
Featured health-economic modeling and author video presentation evaluating the economic shift of worsening heart failure from acute inpatient admissions to outpatient clinic management settings (published in ClinicoEconomics and Outcomes Research).
Demonstrates substantial cost offsets and net budget savings across Medicare longitudinal populations
Accompanied by author video abstract breaking down methodology, budget impact, and hospital admission avoidance
Direct translation of real-world evidence into payer and hospital reimbursement strategy
Saint John's University, New York, New York, College of Pharmacy and Allied Health Sciences
Bachelor of Science in Pharmacy1991
Union University, Albany College of Pharmacy, Albany, New York
Certificate Programs
Executive Program in Pharmaceutical Management2011
Center for Pharmaceutical Management Studies, Rutgers University, Newark, NJ
Certificate Program in Pharmacoeconomics2000
Cost Effectiveness Analysis for Medical Technologies and Pharmaceuticals, Harvard School of Public Health, Boston, Massachusetts
Professional Experience (Industry)
Madrigal Pharmaceuticals — Executive Global Medical Director, Medical AffairsMay 2022 – Present
Chair, Medical Review Committee (MRC) (May 2022 – Jan 2025); Commercialization Content Approval; Academic Steering Committee Governance
Baudax Bio — Vice President of Medical AffairsMay 2021 – May 2022
RIF due to inability to raise; Academic Steering Committee Governance
Calliditas Therapeutics — Executive Director and Head of US Medical AffairsJan 2020 – Apr 2021
RIF due to data readout; Academic Steering Committee Governance (Nefecon); Scientific Communications & Launch MOD/MOA Strategy
Allena Pharmaceuticals — Executive Director and Head of Medical AffairsMar 2019 – Dec 2019
Failed Phase 3 trial; RIF due to data readout; Academic Steering Committee Governance (URIROX-2)
scPharmaceuticals — Senior Director of Medical AffairsMay 2017 – Mar 2019
RIF due to FDA CRL
Cempra Pharmaceuticals — Senior Director, Medical AffairsMar 2016 – May 2017
RIF due to FDA CRL
Vanda Pharmaceuticals — Director, Medical Affairs Strategy, MSLs and Global Health OutcomesJan 2014 – Mar 2016
Successful launch in US and Germany
Ikaria — Manager of Field Medical AffairsJun 2009 – Jan 2014
Reliant Pharmaceuticals / GlaxoSmithKline — Senior Regional Medical Scientist IIMay 2006 – Jun 2009
Reliant acquired by Glaxo
Professional Experience (Clinical)
Associate Director of Pharmacy, Clinical Pharmacology Consultant and Research ServicesMay 1998 – May 2006
University Hospital, Syracuse, New York
Director of Pharmacy ServicesOct 1996 – Apr 1998
University Hospital, Syracuse, New York
Senior Clinical Pharmacist in Critical CareJun 1993 – Oct 1996
University Hospital, Syracuse, New York
Academic Appointments
Research Assistant Professor, Department of Pharmacology2026 – Present
Upstate Medical University, Syracuse, New York
Associate Professor of Medicine, Division of General Medicine, Section-Clinical Pharmacology2003 – 2006
Upstate Medical University, Syracuse, New York
Assistant Professor of Medicine, Division of General Medicine, Section-Clinical Pharmacology1998 – 2003
Upstate Medical University, Syracuse, New York
Assistant Professor of Nursing, School of Nursing1999 – 2006
Upstate Medical University, Syracuse, New York
Adjunct Associate Professor of Pharmacy PracticeSep 1993 – 2006
Union University, Albany College of Pharmacy, Albany, New York
Adjunct Assistant Professor, Department of Pharmacy Practice, Nesbitt School of PharmacyMar 2001 – 2006
Wilkes University, Wilkes Barre, Pennsylvania
Teaching AssistantJul 1991 – May 1993
St. John's University, College of Pharmacy and Allied Health Sciences, New York, NY
Patents, Inventions and Copyrights
Apparatus and Method for Monitoring Nitric Oxide Delivery (Orange Book Listed): Schnitman, Robert; Medicis, Joseph; Potenziano, Jim. US20130118486 A1 (2010).
Method of identifying and treating preterm infant is at risk of Bronchopulmonary Dysplasia: Potenziano, James; Green Douglas S; Medicis, Joseph. US20170212133 A1 (2013).
Grants / Research
FDA office of Orphan Product Development NIH grant: Phase 2 Study of Pulsed Inhaled Nitric Oxide vs Placebo for Pulmonary Arterial Hypertension. PI Brahm Goldstein, Doug Greene, Joseph Medicis, Larry Palmisano, Lisa Cooper ($1.6M over 4 years; high ranking unfunded).
Ularitide: Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation PK/PD Study in Acute Decompensated Heart Failure ($45,000.00 per patient).
Rivaroxaban (BAY 59-7939): Event-Driven Non-inferiority Study Comparing Efficacy and Safety vs Adjusted-Dose Warfarin for Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation.
Apixaban (CV185030): Phase III Active-Controlled Study in Nonvalvular Atrial Fibrillation ($6,000.00 per patient).
ATHENA: Dronedarone 400mg Bid Trial in Atrial Fibrillation/Atrial Flutter.
TRITON TIMI-38: CS-747 vs Clopidogrel in Acute Coronary Syndrome Subjects undergoing PCI.
EARLY ACS: Early Front-loaded Eptifibatide in Non-ST-segment Elevation Acute Coronary Syndrome ($3,000.00 per patient).
IMPROVE IT: Vytorin vs Simvastatin Monotherapy in High-Risk Subjects with Acute Coronary Syndrome ($6,000.00 per patient).
PLATO: AZD6140 vs Clopidogrel for Prevention of Vascular Events in Acute Coronary Syndromes ($7,500.00 per patient).
RED-HF (Amgen): Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure Subjects with Systolic Dysfunction and Anemia ($24,000.00 per patient).
Aliskiren: Phase 3 studies in primary hypertension ($8,000.00 per patient).
Amgen Inc. Pharmaceuticals: Darbepoetin alfa in the ICU for Prevention of Transfusions ($82,400.00, 2005).
The Merck Pharmaceutical Award: Cost Effectiveness of Fomepizole versus Ethanol in Acute Ethylene Glycol Toxicity ($1,000.00, 2003).
Kim, Y., Medicis, J., Davis, M. et al. Progression from Non-alcoholic Steatohepatitis to Advanced Liver Diseases and Mortality Among Medicare Patients. Adv Ther 41, 4335-4355 (2024).
Qian, C., Fishman, J., Szabo, S.M., Kim, Y., Medicis, J., Rochon, H., Sun, R. and Charlton, M., 2024. Real-World Clinical Outcomes Associated with Progression and Cirrhosis in Metabolic Dysfunction-Associated Steatohepatitis.
Kim, Y., Qian, C., Fishman, J., Szabo, S.M., Rochon, H., Sun, R., Medicis, J. and Charleton, M., 2024. 1054-P: Characterizing Clinical and Economic Outcomes among Patients with MASH and Type 2 Diabetes Mellitus Treated with Glucagon-Like Peptide 1 (GLP1)-A Cohort Study. Diabetes, 73(Supplement_1).
Fitch K, Lau J, Engel T, Medicis JJ, Mohr JF, Weintraub WS. The cost impact to Medicare of shifting treatment of worsening heart failure from inpatient to outpatient management settings. ClinicoEconomics and Outcomes Research. 2018; (10): 855-863.
Boyer TD, Medicis JJ, Potenziano J, Jamil K. A multi-center randomized placebo controlled double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin (REVERSE TRIAL). Journal of Clinical Trials. 2012; (4): 39-49.
Clark JE, Lazzaro RJ, Miller DA, in collaboration with Medicis JJ et al. ASHP statement on the roles and responsibilities of the pharmacy executive. Am J Health Syst Pharm. 2009; 66(5):499-502.
Lehmann DF, Page N, Kirchman K, Sedore A, Guharoy S, Medicis J, Ploutz R, Weinstock R, Duggan D. Every Error a Treasure: Improving Medication Use with a non-punitive Reporting System. The Joint Commission Journal on Quality and Patient Safety. 2007; 33(7): 401-407.
Lehmann DF, Medicis JJ, Franklin P. Polymorphisms and the Pocketbook: The Cost-Effectiveness of Cytochrome P450 2C19 Genotyping in the Eradication of Helicobacter pylori infection associated with Duodenal Ulcer. Journal of Clinical Pharmacology. 2003; 43:1316-1323.
Darko W, Medicis JJ, Smith A, Guharoy R, Lehmann DF. Mississippi mud no more: Cost Effectiveness of pharmacokinetic dosage adjustment for vancomycin to prevent nephrotoxicity. Pharmacotherapy. 2003; 23(5):643-650.
Mascia M, Kotch M, Medicis J. Pharmacoeconomic Impact of Guidelines for Analgesia, Sedation, and Neuromuscular Blockade in Critical Care. Critical Care Medicine. 2000; 28(7):2300-2306.
Medicis JJ., Stork CM., Howland MA., Hoffman RS., Goldfrank LR. Pharmacokinetics of a Continuous versus Short Infusion of Pralidoxime in Human Volunteers. Journal of Toxicology and Clinical Toxicology. 1996; 34(3):289-295.
Awards / Honors
Madrigal Symphony Award (2024)
Ikaria Intellectual Property Inventor Award (2013)
Ikaria Impact and Corporate Achievement awards (2011, 2012, 2013)
Fellowship, American College of Clinical Pharmacology (2009)
Fellowship, American Society of Health System Pharmacist (2004)
New York State Council of Health System Pharmacists Dedicated Service Award (2007)
Bristol Myers Squibb Pharmacy Leadership Award (2006)
Novartis Pharmaceuticals Leadership Award (2006)
Pharmacist of the Year, Central New York Society of Health-System Pharmacists (2005)
Clinical Practitioner of the Year Award - NYS American College of Clinical Pharmacy Chapter (1998)
