Learn more about our Executive Leadership Committee by clicking on their name below.
Kirk Shepard, MD
Senior Vice President, Head of Global Medical Affairs Oncology
President 2016-2017, Medical Affairs Professional Society
Dr. Kirk Shepard is the 2016-2017 President of the Medical Affairs Professional Society and has more than 25 years of experience in the pharmaceutical industry. He is a board-certified medical oncologist and hematologist physician. He is currently Senior Vice President, Head of Global Medical Affairs Oncology at Eisai Pharmaceutical Company.
Dr. Shepard’s experience in multiple therapeutic areas includes operational and strategic product development from Phases I through IV and the diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, health economics & outcomes research & patient access, data generation, field-based medical teams (MSLs), PV/safety, medical communication & publications, patient advocacy, and public relations. In 2015, he was selected as one of the 100 Most Inspiring People in the Pharmaceutical Industry (PharmaVOICE).
Before his pharmaceutical career, Dr. Shepard served as a staff physician in the Department of Hematology and Medical Oncology at the Cleveland Clinic Foundation, where he supervised numerous studies in oncology and symptom control. He has more than 50 medical publications in journals and books. Dr. Shepard earned his bachelor’s degree from Cornell University in Ithaca, NY, and his medical degree from the University of Cincinnati Medical School in Cincinnati, OH. He completed both his internship and residency in internal medicine at Case Western Reserve University in Cleveland, OH, and fellowships in hematology and oncology at the University of Chicago Hospitals and Clinics in Chicago, IL.
Gail Cawkwell, MD, PhD
Senior Vice President, Medical Affairs
Dr. Gail Cawkwell joined Intercept on February 12, 2018 as Senior Vice President of Medical Affairs. She and her team are responsible for providing trusted medical and scientific expertise to healthcare professionals, payers, patients, health systems, and others to assure their understanding and knowledge of Ocaliva and relevant liver diseases.
Gail has more than 17 years of pharmaceutical development and medical affairs experience. Prior to joining Intercept, Gail was Chief Medical Officer at Purdue Pharma, and, prior to that, she was Vice President in the Medicines Development Group at Pfizer. She began her pharmaceutical career as Medical Director for Pfizer’s Celebrex and progressed to roles of increasing responsibility in Pfizer’s US and Global Medical Affairs functions.
Gail received a BS degree at Duke University, an MD degree from McGill University and completed a PhD at the University of Cincinnati in the Department of Environmental Health, Division of Biostatistics and Epidemiology. She completed a Residency in Pediatrics at Duke University Medical Center and a Fellowship in Pediatric Rheumatology at Cincinnati’s Children’s Hospital Medical Center.
Victoria Elegant, MBBS, DRCOG, FFPM
Vice President and Region Head Medical, JAPAC
Prof Elegant is currently Vice President and Region Head Medical, JAPAC at Amgen, and is an adjunct professor in the Faculty of Medicine at the University of New South Wales in Australia. She joined Amgen in 2016 after previously serving as Vice President, Medical Affairs for Baxalta. Prior to Baxalta, Prof Elegant was at Baxter Healthcare for 9 years where she was Vice President of Medical and Regulatory Affairs, Asia Pacific.
Ramin Farhood, PharmD, MBA
Vice President, Head of Global Medical Affairs
Dr. Ramin Farhood is a Senior Level Biotechnology and Pharmaceutical Executive with 20 years of experience in scientific and strategic operational leadership in Global Medical Affairs (GMA), Scientific Affairs and Shared Medical Excellence. His expertise is vast in building scalable world-wide organizational and operational capabilities of Medical Affairs while driving efficiencies and implementing best practices. His diverse therapeutic expertise spans across Oncology, Hematology, Immunology, and Ophthalmology.
Currently, Dr. Farhood is the Vice President, Head of Global Medical Affairs at AveXis. In this role, he is a key member of the senior leadership team accountable for World-Wide Medical Affairs organization. Previously, he served as the VP, Head of External Scientific Affairs for Shire who recently acquired Baxalta in July 2016. In this role, he was responsible for developing a strategic vision for the Medical Affairs Evidence Generation group. His accountabilities encompass Medical Evidence Generation, Continuum of Access to Medicines, Laboratory Services, Home Therapy Support, HCP Engagement Support & Educational Grants, Investigator Initiated Trials (IITs) and Professional Society Engagement Support. Here, he has been an inspirational leader who serves as a strategic business partner, cultural and change steward and operational expert.
Prior to his current role, he served as the Head of Medical Operations and Strategy at Baxalta. During his tenure, he built a flexible and scalable world-wide organizational and operational capability of Medical Affairs via centralizing common medical and operational activities globally with centralized hubs in the regions, driving efficiencies and productivities, and sharing and implementing best practices.
Earlier in his career, as Head of Global & US Medical Affairs for Immunology Franchise at Baxter, he was responsible for overseeing the Immunology franchise, leading the development and implementation of medical and commercial strategies, Life-Cycle Management and launch of products. This experience included diverse disciplines of medical and commercialization of drugs, such as leading medical communications and publications, Investigated Initiated Trials (IITs), educational activities (CMEs/IMEs), field-based medical teams (MSLs) and field-based outcome research teams (MSOLs), compliance and SOP developments.
Dr. Farhood acquired his Doctorate in Pharmacy from the University of Southern California (USC) and an MBA from the University of California, Los Angeles (UCLA). He currently holds the position of Adjunct Professor at the School of Pharmacy at USC and Keck Graduate Institute (KGI) and has established industry Post-Doctorate Fellowship programs in the US. He has been selected as the recipient of the Alumnus of the Year Award for his distinguished career, leadership, and contribution to the profession as a clinician, educator, and executive.
Dr. Farhood’s vast skills and knowledge have made him a leading and sought after expert in the industry. He is a frequent speaker at executive medical leadership forums and trainings, has multiple publications in industry journals and has written book chapters related to Medical Affairs. He is on the Board of Directors for the Medical Affairs Professional Society (MAPS) and holds membership in numerous professional affiliations.
Ann Ford, BSN, JD
Chief Ethics and Compliance Officer
Medline Industries, Inc.
Ann Ford currently serves as Chief Ethics and Compliance Officer at Medline Industries, Inc., in Northfield, IL. After completing her nursing education at Marquette University in Milwaukee, WI, she received her Juris Doctor degree from DePaul University College of Law in Chicago, IL.
Until she became an attorney, Ms Ford worked in high-risk obstetrics, pediatric intensive care, and neonatal intensive care. Upon graduating from law school, she spent 11 years in private practice representing physicians, nurses, and hospitals. After private practice, Ms Ford transitioned to in-house legal and compliance roles, including Vice President, General Counsel for two Chicago-area hospitals. In her current role as Chief Ethics and Compliance Officer at Medline, she oversees the global ethics and compliance program. In addition, she has been intimately involved with the development of a medical affairs function at Medline.
Ms Ford has served on various committees throughout her career, including the hospitals’ Institutional Review Boards. She is a frequent speaker on healthcare legal and compliance topics.
Robert J. Matheis, PhD, MA
Executive Director and Head of Global Scientific Communications
Robert J. Matheis, PhD, MA is Executive Director and Head of Global Scientific Communications with Celgene located in Summit, NJ. He is Past President of the International Society for Medical Publication Professionals (ISMPP), a global organization headquartered in Tarrytown, NY. Prior to joining Celgene, Dr. Matheis was Head of Evidence Based Medical Communications for Sanofi, headquartered in Gentilly, France. He was trained as a clinical psychologist and obtained a masters degree in behavioral statistics.
Dr. Matheis has over 14 years of medical research and communications experience in both government and industry. He has conducted research, provided treatment, and instructed within a variety of clinical and academic capacities related to aging, brain and spinal cord injury, multiple sclerosis, diabetes, and other neurocognitive disorders. Dr. Matheis advocates for the evolution of medical communication tools to translate medical evidence for use by health care decision makers, providers, and patients. He champions innovation and novel technology in medical communications. Most recently, Dr. Matheis has been involved in conceptualizing and synthesizing performance indicators to support a strong value proposition for medical affairs organizations.
Dr. Matheis has an extensive bibliography of scientific congress presentations and peer-reviewed publications across various disease states, in addition to research and publication accomplishments in alternative medicine and psychosocial factors impacting healthcare.
Thérèse McCall, PhD, MBA
Global Medical Affairs Strategy and Communications Leader
Dr. Thérèse McCall is the former Vice President of Global Medical Communications and Professional Strategies AbbVie, Inc. in Chicago, IL. She received a doctorate in clinical medicine from Trinity College in Dublin, Ireland, and a master’s degree in business administration from Northwestern University in Evanston, IL. She also holds a diploma in print journalism and radio broadcasting.
Dr. McCall has over 30 years of leadership experience with global companies in the fields of drug discovery, research and product commercialization strategy, clinical development, and regulatory approval. She has deep expertise in external stakeholder engagement and is focused on global medical affairs innovation, product commercialization, and medical communications transformation. During her career, Dr. McCall has consistently developed innovative medical and commercial strategies and solutions. She has led US and global initiatives involving external thought leader and reimbursement decision makers, investigator research programs, publications, medical information, and regulatory and compliance activities. Her therapeutic expertise includes oncology, immunology, gastroenterology, cardiology, neuroscience, and diabetes.
Dr. McCall has a long-standing interest in advancing the public’s understanding of science. To this end, she has developed and presented radio interviews and school presentations, and she has worked as a London-based science correspondent for the BBC. In addition, Dr. McCall has authored over 30 scientific publications, including newspaper and book chapters.
Robin L. Winter-Sperry, MD
Head, Global Field Based Medical Excellence & Insights
Global Medical Operations
Dr. Robin Winter-Sperry started working in the industry in the area of Dermatology. She has had a long and distinguished career including Sanofi/Genzyme Global Medical Affairs, Strategy & Tactics in the area of Multiple Sclerosis and President and CEO of Scientific Advantage, LLC. She created Novartis’ Medical Science Liaison (MSL) department of Scientific Operations and Sanofi-Synthelabo’s Medical Therapeutic Liaison division.
She has been involved in over 28 product launches. She has pioneered the recognition of MSLs as a specialty in the biopharmaceutical and device industry and is responsible for creating and developing many of the industry’s leading Medical Affairs and Medical Liaison teams.
Ornah Levine-Dolberg, MD
Vice President & Global Head of Medical Affairs
Research & Development
MAPS EMEA President
Dr. Ornah Levine-Dolberg graduated from the Ben Gurion University, Medical School in 1990. Following her residency in Psychiatry completed cum laude, she was the Director of the Day Hospital at the Sheeba Medical Center in Israel for 7 years. His first industry role was in 2003 as a Country Medical Director for Lundbeck. After 3 years in that role she moved to Copenhagen to take up various roles in Global Medical Affairs, including heading the department of Scientific Communications, responsibility for a competitive ISS program, and being the Global Medical Director for escitalopram, a highly successful treatment for Mood and Anxiety Disorders. One of her final roles in Lundbeck was the launch of escitalopram in China.
Dr Ornah Levine-Dolberg joined Teva Pharmaceuticals in mid-2013 to head the newly formed Medical Affairs, Growth Markets. From a team of 2 this department has grown to more than 100 employees. Dr Levine-Dolberg established all functions in this team including Medical Operations and Excellence, Therapeutic Area Leads and their operating model, Country Medical Directors and their departmental structures and deliverables. On a regional level, she built various infrastructure capabilities such as Medical Information, promotional material review, governance bodies, operating models, KPIs, financial structures, and a strategic project called Signature Medical Moves. In addition, Ornah was part of the leadership team of Growth Markets and a prominent member of the Global Medical Affairs Leadership team.
In September 2016 Ornah joined Glenmark Pharmaceuticals in their London headquarters to establish and launch Global Medical Affairs and to help the company in its transition from a medium sized Indian company to a global presence with expertise in all facets of drug development and commercialization.
Charlotte Kremer, MD MBA
EVP and Head of Medical Affairs
Charlotte M. E. Kremer, MD, MBA is the Executive VP and head of Medical Affairs for Astellas. In this role, Dr. Kremer provides leadership for the Medical Affairs organization globally.
Dr. Kremer joined Astellas in 2012 with 20 years of experience in the pharmaceutical industry. Prior to Astellas, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer. While at Pfizer, she successfully led and executed the clinical development and global medical programs in these respective areas. Prior to joining Pfizer, Dr. Kremer held positions of increasing responsibility providing medical support, developing Phase 3b/4 clinical trials, and initiating and directing a Medical Liaison program at Organon Pharmaceuticals, both in the Netherlands and in the United States. A native of the Netherlands, Dr. Kremer received her medical degree from the University of Utrecht, The Netherlands. She went on to receive her Diploma Pharmaceutical Medicine (DPM) from Universite Libre de Bruxelles. After transferring to the United States, Dr. Kremer completed the Executive MBA program at New York University’s Leonard N. Stern School of Business.
Peter Piliero, MD
Global Medical Affairs
Dr. Peter Piliero currently leads the Global Medical Information (GMI) group within Global Medical Affairs (GMA). GMI is a collaborative group of scientifically-trained professionals who are therapeutically-aligned. The group’s core activities are (1) to support the development and approval of appropriate scientifically accurate and clinically relevant medical information that may be disseminated to Health Care Providers (HCPs) world-wide or used by GMA personnel for their interactions with HCPs; (2) to conduct medical review of US and global promotional materials; and (3) to provide scientific training and knowledge management for GHH.Dr. Piliero is recognized as a Medical Affairs expert having held various leadership positions at Boehringer Ingelheim Pharmaceuticals, Inc. for over 12 years. Prior to joining Merck he was Vice President of General Medicine and Scientific Affairs in US Clinical Development and Medical Affairs. As such he was responsible for the Immunology, CNS, and Virology therapeutic areas in addition to Medical Education and Research Grants, Medical Publications, and Field Based Medicine Operations. Previously, he led groups responsible for Virology, Metabolism, Women’s Health, and Consumer Health Care.
Dr. Piliero is a board eligible Internal Medicine and Infectious Disease specialist who practiced for 11 years at Albany Medical College. He completed an accelerated 7-year BS-MD program at City College of New York and SUNY at Stony Brook School of Medicine. He completed an Internal Medicine residency at The Presbyterian Hospital in New York and Infectious Disease fellowship in the Harvard Combined Infectious Diseases program in Boston.
Randall Kaye, MD
Global Head of Medical Affairs
Dr. Randall Kaye serves as the Global Head of Medical Affairs at SSI Strategy. He focuses on providing a medical and scientific perspective to our transformative initiatives in Medical Affairs and Pharmacovigilance. Dr. Kaye also plays a key role in SSI’s bespoke advisory services and regulatory compliance offerings.
Randall Kaye, MD serves as Chief Scientific Officer at SSI Strategy, a boutique consulting firm focused on Medical Affairs, Pharmacovigilance and Clinical Development. In Dr. Kaye’s role at SSI Strategy, he focuses on providing a medical and scientific perspective to transformative initiatives in Medical Affairs and Pharmacovigilance. He plays a key role in SSI’s bespoke advisory services and regulatory compliance service offerings.
Most recently, Dr. Kaye was Chief Medical Officer at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases. While at Axsome, Dr. Kaye developed and executed all Clinical Research functional areas that resulted in the initialization of three clinical programs (IND Filing, FPI) in less than one year. Prior to joining Axsome, Dr. Kaye was Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka), a CNS specialty company. While at Avanir, Dr. Kaye provided leadership and vision to the clinical, regulatory and medical affairs areas, and supported the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Prior to Avanir, Dr. Kaye served in a variety of medical affairs leadership positions at Scios Inc. (acquired by Johnson and Johnson) a cardiovascular specialty company, InterMune Inc. (acquired by Roche), a specialty company focusing on Idiopathic Pulmonary Fibrosis and Pfizer Inc.
Dr. Kaye earned his Doctor of Medicine, Masters in Public Health and Bachelor of Science degrees at The George Washington University in Washington, D.C. Dr. Kaye trained in Pediatrics at the University of Massachusetts Medical School and was a Research Fellow in Allergy and Immunology at Harvard Medical School.
Joseph Kohles, PhD
Chief Medical Officer
Envision Pharma Group
Joseph Kohles, PhD, is a dynamic leader with more than 20 years of research and industry-side pharmaceutical experience, both in medical affairs and clinical research. In addition to a broad range of experience across multiple therapeutic areas, including oncology, osteoporosis, pain and diabetes, Dr. Kohles has written and published more than 20 peer-reviewed manuscripts and over 60 abstracts and posters spanning basic research, preclinical, clinical, health outcomes, and pharmaco-economic analysis.
In his current role as Chief Medical Officer of Envision Pharma Group, Dr. Kohles has been instrumental in driving the strategic direction of the organization. His previous industry experience included leading the oncology medical affairs team for a large Fortune 100 pharmaceutical company in the U.S. In this capacity, Dr. Kohles guided the overall medical strategy and led the team in execution of clinical trials, data analyses, publications plans, and overall medical support.
Mary Alice Dwyer, PharmD
VP, Global Medical Excellence
Global Medical Affairs
Mary Alice Dwyer, PharmD, is Vice President of Global Medical Excellence (GME) in Global Medical Affairs (GMA). She leads the GME organization which includes Global Publications, Global MSL Excellence, Global Nominated Signatory, the Medical Academy, Medical Resources, and most recently, Patient Centricity (PaCe). In this role, she leads the partnership between GME and Medical in the regions and countries to build and sustain medical capabilities, skills and knowledge. The Global Publications and PaCe functions under Mary Alice’s leadership are also instrumental to lead AZ’s patient-driven science and achieve confident use of our medicines in clinical practice.
Mary Alice first joined AstraZeneca in 2004 as the Executive Director of Scientific Affairs, and was subsequently promoted to Vice President of Medical Affairs in the US. She has also led scientific and medical teams at Takeda, Pharmacia, and Searle. She previously worked in clinical drug development at Hoffmann-LaRoche and Glaxo. Mary Alice is based in Gaithersburg, Maryland.