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The R&D Leadership Team

Our Research & Development Leadership Team



Research & Development

Research & Development

Judith Hinton Andrew, Rock Composite 22
Judith Hinton Andrew, Rock Composite 22



As Global Head of R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson, Mathai’s mission is to focus the energy of the best research and development teams in the world at the intersection of profound unmet medical need and actionable breakthroughs in science and technology to make medicines of unequivocal benefit for humanity.  The team works across a wide range of therapeutic areas and biological pathways. Janssen’s approach to medicines is patient-focused, agnostic to both source of the idea and the treatment modality.  The team is invested deeply in data sciences in every aspect of R&D.  Janssen R&D has fueled the growth of Janssen to be the largest pharmaceutical company in the United States, and the fourth largest in the world.

Prior to joining Janssen in June 2017, Mathai was Senior Vice President at Merck Research Laboratories, responsible for research in the areas of Cardiovascular, Metabolic and Renal Diseases, Oncology/Immuno-Oncology and Immunology. Jointly with his team, he initiated numerous new programs and progressed eight into early clinical development. Prior to Merck, Mathai led R&D at Theravance, a company he co-founded in the San Francisco Bay Area in 1997 based on his work at Harvard University. His talented team of 200 scientists nominated 31 development candidates in 17 years, created five approved products and created a pipeline containing many additional late development-stage compounds. In 2014, he and the Theravance Leadership Team separated Theravance into two publicly traded companies: Innoviva (INVA) and Theravance Biopharma (TBPH).

Mathai has more than 150 peer-reviewed publications and patents and serves on various boards and advisory committees. He received his M.D. from Harvard Medical School/Massachusetts Institute of Technology (HST program) and his Ph.D. in Chemistry from Harvard University's Department of Chemistry, working with George Whitesides. He received his BSc in Chemistry and Biochemistry from Dalhousie University in Halifax, Nova Scotia.

Mathai Mammen, M.D., Ph.D.




As Global Head of Discovery Sciences (DS), Percy develops and drives the global small molecule discovery strategy for the Janssen early research portfolio, ensuring alignment with Therapeutic Area (TA) priorities and Janssen R&D imperatives. He leads a global organization of 700+ employees who comprise five key functions: Computational Sciences; Discovery Chemistry; Drug Metabolism & Pharmacokinetics; Lead Discovery; and Core Business Services. Percy works in collaboration with TA discovery scientists and other stakeholders to define and operationalize innovative strategies for the successful identification and optimization of novel leads into drug candidates to fill the Janssen pipeline.

Prior to his role with Janssen, Percy was Senior Vice President and Head of Discovery for Bristol-Myers Squibb (BMS). Prior to that, he was Senior Vice President and Head of Discovery Chemistry & Molecular Technologies and was also Site Lead for the Biocon-BMS R&D Center in Bangalore, India. Percy began his career as a Senior Research Scientist in Chemical and Physical Sciences at DuPont Pharmaceuticals (1999 – 2001) and joined BMS when the company acquired DuPont in 2001.  During his combined time at BMS and DuPont, he collaborated with a wide range of colleagues to help build the immunoscience pipeline.  In 2013, after moving into a cross-therapeutic area role, Percy worked on advancing the portfolio and driving innovation in supporting technologies, non-traditional modalities, and novel external partnerships.

Percy is the inventor or co-inventor on more than 25 U.S. patents and has authored or co-authored more than 75 peer-reviewed research publications.

He received his bachelor’s degree in Organic Chemistry from Dartmouth College, his Ph.D. in Chemistry & Chemical Biology from Harvard University, and completed a post-doctoral fellowship at Harvard Medical School and Massachusetts General Hospital. In 2014, he received his M.B.A. from the Massachusetts Institute of Technology.

Percy H. Carter, M.B.A., Ph.D.

Global Head
Discovery Sciences



Martin is responsible for all aspects of the Actelion Research & Development strategy and execution across its growing portfolio of assets in Pulmonary Arterial Hypertension and beyond. In addition, he serves as the Global Therapeutic Area Head, Pulmonary Hypertension.

Martin joined Actelion in 2017 from Johnson & Johnson Medical Devices, where he led global Research & Development across the company’s three Medical Devices franchises – DePuy Synthes, Ethicon and Cardiovascular & Specialty Solutions. Prior to that, Martin served as Global Head of Research & Development for the DePuy Synthes Companies of Johnson & Johnson.

Originally joining Johnson & Johnson in 2000, Martin has served as Chief Operating Officer for Janssen Research & Development, overseeing operational excellence and execution of clinical development programs, thereby maximizing effectiveness and efficiency in bringing new medicines to patients. As Global Therapeutic Area Head for Cardiovascular & Metabolism R&D, he was responsible for the development of compounds in cardiovascular disease and diabetes. Martin has also held roles in medical affairs and R&D for Sanofi and Novartis.

Having earned his degree at the University of Nottingham Medical School in Nottingham, UK, Martin became a Fellow of the Royal College of Surgeons of England in 1995, and later joined the Faculty of Pharmaceutical Medicine in London, United Kingdom.

Martin Fitchett, M.D.




As Global Leader for Pharmaceutical R&D Communications, Paul leads development and execution of comprehensive communication strategies to enhance the reputation and support the research & development and innovation priorities of Janssen and Johnson & Johnson.

Prior to joining the company, Paul served as vice president, R&D network relationships and strategic communications at Takeda, where he led the global R&D communications team and served as communications counselor to the chief medical and scientific officers. He served on the core team that identified industry drivers of innovation, including modality diversification, external innovation and data sciences, then mapped and implemented Takeda’s pivotal R&D transformation.

Before joining Takeda, Paul served as Managing Director for Chandler Chicco Agency based in New York City. During his 12 years at Chandler Chicco, he and his team provided extensive support for several Janssen medicines in the areas of oncology and cardiovascular & metabolism.

Paul Graves




As Chief Operating Officer, Development, Janssen R&D, Stef Heylen, M.D., leads Development Management, Operations and Analytics. In addition, he is responsible for the Beerse campus as Managing Director, Janssen Pharmaceutica NV Belgium. In his global role, he oversees the development process overall, as well as essential analytical capabilities (portfolio, statistics, clinical operations), and is accountable for operationalizing and managing the extensive development portfolio.

During his career with Johnson & Johnson (J&J), Stef served with the Johnson & Johnson Innovation Program Office supporting the Johnson & Johnson Chief Scientific Officer in driving meaningful innovation and leveraging innovation capabilities across all sectors of the enterprise. He also was Head of R&D and Chief Medical Officer for Janssen Alzheimer Immunotherapy R&D, LLC, and he developed and implemented an integrated Research and Early Development (RED) Neuroscience strategy for the Beerse, Belgium site as Chief Medical Officer, Johnson & Johnson Pharmaceutical R&D, RED EU. From 2003 to 2007, Stef served as Site Head, Vice President of Development and Chairman of the Development Management Committee for Tibotec, a company acquired by J&J in 2002. During his tenure, two of the company’s HIV medicines were granted accelerated approval.

Before joining Tibotec, Stef was Vice President, Development & Regulatory Affairs at Crucell in Leiden, the Netherlands, and held several senior positions within Janssen including Vice President, Global Regulatory Affairs and Pharmacovigilance, and Vice President, Medical Affairs for the Europe, Middle East and Asia (EMEA) region. He joined the Janssen Research Foundation in 1987 and led the global clinical development of one of the most successful Janssen antipsychotic medicines.

Stef obtained his M.D. at the University of Leuven, Belgium, and the Prince Leopold Institute for Tropical Medicine in Antwerp, Belgium. He is a 1993 recipient of the Dr. Paul Janssen Award for R&D.

Stef Heylen, M.D.

Chief Operating Officer



Najat Khan, Ph.D., is the Global Head (Vice President) for Strategy & Operations at Janssen Research & Development. In this role, Najat shapes the R&D strategic vision and operationalizes across multiple high priority areas to ensure Janssen R&D continues to deliver on transformational medicines for patients. These include building new capabilities such as creating a best-in-class R&D data science organization by selecting the highest priority questions to pursue, systematically deploying Data Science capabilities, while being a key catalyst in forming strategic external partnerships to accelerate on-going efforts. Najat also collaborates with the various Janssen R&D therapeutic and functional heads, as well as Commercial and Business Development leaders on a wide variety of cross-functional strategic, portfolio related, and operational priorities while ensuring the respective insights are incorporated effectively within the broader Janssen community.

Prior to her current role, Najat was the Head of R&D Strategic Initiatives. In a brief period, she was able to develop and execute a comprehensive program comprising of more than 23 of Janssen’s R&D strategic initiatives, and was instrumental in launching our data science efforts, defining our R&D strategy for pursuing opportunities in new diseases area, enhancing early stage external innovation, etc.

Najat has more than 10 years of global healthcare experience in pharmaceutical, biotechnology, business and academia. Prior to joining Janssen, she was a Principal at The Boston Consulting Group (BCG) where she has led and executed multiple strategic initiatives across research, commercial, business and clinical development, mergers and acquisitions and operations. Within R&D, areas of focus included portfolio governance and decision-making, R&D operating model optimization (including both clinical development and operations), external innovation and Digital Health. While at BCG, Najat also led the implementation of the Women’s Mentorship program and recruitment and retention efforts as recruiting director and career development advisor.

Najat received her B.A. in Chemistry with a minor in Economics from Colgate University and her Ph.D. in Organic Chemistry from the University of Pennsylvania with publications in high impact journals such as Nature, Proceeding of the National Academy of Sciences, etc. She was also a fellow at the Penn Center for Innovation and led multiple licensee / partnership arrangements between the University of Pennsylvania and leading pharmaceutical and large capital biotech companies.

Najat Khan, Ph.D.




As Global Oncology Therapeutic Area Head for the Janssen Pharmaceutical Companies of Johnson & Johnson, Peter F. Lebowitz, M.D., Ph.D. is responsible for end-to-end discovery, development and life cycle advancement of the company’s robust oncology pipeline and portfolio. He leads a global team of scientists that bring together expertise in small molecules, advanced biologics, cell therapies, vaccine platforms, translational research, diagnostics, and immuno-oncology. Under Peter’s leadership, Janssen Oncology has achieved many noteworthy milestones including seven major product approvals in the last eight years for such first-in-class therapies as IMBRUVICA® (ibrutinib), DARZALEX® (daratumumab) and ERLEADA® (apalutamide); seven U.S. Food and Drug Administration Breakthrough Therapy Designations; and tremendous, rapid growth within the group’s early development portfolio.

With a strategy focused on driving towards transformational therapies, Peter also successfully established an external innovation strategy to advance science and novel therapeutics in core disease areas, including hematologic malignancies, prostate cancer, immuno-oncology, and lung cancer. The combination of these efforts has led to more than 80 strategic oncology partnerships across the life sciences ecosystem and continues to distinguish Janssen as an industry leader and global oncology innovator.   

Prior to his appointment as Global Oncology Therapeutic Area Head, Peter served as the Hematologic Malignancy Disease Area Leader within Janssen Research & Development. In this role, he had responsibility for creating and executing the scientific strategy to advance internal and externally-sourced discovery and development programs. Together with his team, Peter is recognized for building an industry-leading hematologic malignancy portfolio that has been foundational for scientific innovation and has progressed important therapeutics that have transformed patient care.

Before joining Janssen R&D, Peter held Vice President positions in Discovery and Early/Late-stage Clinical Development for GlaxoSmithKline where he successfully filed 10 Investigational New Drug applications and played a significant role in the global registration of three oncology medicines. During his tenure, he also directly led major programs from preclinical discovery through pivotal Phase 3 registration trials.

Prior to transitioning to the pharmaceutical industry, Peter served as an Assistant Professor of Medicine, Division of Hematology/Oncology at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center. There he established an independently funded translational and clinical research program and led numerous clinical research programs as a principal investigator. He also had the privilege of caring for many oncology patients during this time. Peter graduated magna cum laude from Harvard University, holds a master’s degree in Health Care Policy from Oxford University, and earned his medical degree and doctorate from the University of Pennsylvania School of Medicine. He completed his postgraduate clinical training in Internal Medicine at Duke University Medical Center and his Hematology/Oncology fellowship at the National Cancer Institute, National Institutes of Health. He has been board certified in Internal Medicine and Medical Oncology.

Peter Lebowitz, M.D., Ph.D.

Global Therapeutic Area Head



David M. Lee, M.D., Ph.D., is Global Immunology Therapeutic Area Head for the Janssen Pharmaceutical Companies of Johnson & Johnson where he leads a team focused on end-to-end pipeline and a portfolio of treatments for immune-mediated disease. Under his leadership, Immunology researchers are working to build on the success of our current portfolio, which includes STELARA® (ustekinumab) and REMICADE® (infliximab), two of Johnson & Johnson’s largest products. 

Prior to joining Johnson & Johnson in September 2018, David was based in Basel, Switzerland, where he served as Global Head, Immunology, Inflammation and Infectious Disease Discovery and Translation Area for Roche, and prior to that, as Global Head of Autoimmunity, Dermatology, and Transplant Translational Medicine at the Novartis Institutes for BioMedical Research. In each of these roles, he led on the strategic approaches that fed those companies’ pipelines, prioritized assets, and accelerated their development. His ability to develop external collaborations and to lead and develop his teams was central to his success in each organization.

Before transitioning to the pharmaceutical industry, David was a faculty member at Brigham and Women’s Hospital/Harvard Medical School. While there, his research laboratory focused on disease mechanisms in Rheumatology and he also practiced Rheumatology. As a precursor to his career in industry, while at Harvard, he also participated in co-founding multiple start-ups. Ultimately, one – a biotech – was acquired by a major pharmaceutical company.

He is an active author and speaker, having completed more than 80 peer-reviewed publications and book chapters, and more than 100 lectures/seminars.

David earned his undergraduate degree at Stanford University, where he discovered his fascination with the intricacies of the immune system. He subsequently earned his M.D. and Ph.D. in Microbiology/Immunology from the Duke University School of Medicine. His passion for developing new medicines is rooted in his experiences treating patients as a practicing rheumatologist. 

David M. Lee, M.D., Ph.D.

Global Therapeutic Area Leader



As Head of Asia Pacific R&D, Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region.

Zili joined Janssen in June 2019 from the U.S. Food and Drug Administration (FDA) where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017.

Before rejoining the FDA in 2015, Zili had over 10 years of leadership and program management experience in pharmaceutical R&D at both Merck and the Bill and Melinda Gates Foundations, where he built high-performance and science-driven organizations and drove substantial increases in R&D productivity. At Merck, he served in positions of increasing responsibility in clinical development and regulatory affairs at global, regional and local levels. His roles included Medical Director of MSD China, Head of China and Asia Pacific Regulatory Policy, and Executive Director and Head of Emerging Markets Regulatory Strategy. At the Bill & Melinda Gates Foundation, Zili served as Deputy Director and Head of China R&D.

Zili first joined the FDA in 2000 as a medical reviewer for drug safety. Later he was promoted to medical team leader for overseeing IND and NDA reviews in defined therapeutic areas. In addition, Zili participated in FDA guidance development for the industry and presented at the FDA’s advisory committee meeting on behalf of the agency. Zili was a recipient of numerous FDA awards, including 2003 FDA Scientific Achievement Award and 2014 FDA Distinguished Alumni Award.

Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000. In addition to his medical degree, Zili also holds two master’s degrees in public health.

Zili Li, M.D., M.P.H.

Head of Asia Pacific R&D
Janssen Research & Development



James F. List, M.D., Ph.D. is the Global Therapeutic Area Head of Cardiovascular & Metabolism (CVM), leading a global team focused on creating new solutions for improving cardiovascular and diabetes care and disease interception. Jim has end-to-end research and development responsibility for the Janssen CVM portfolio, including drug discovery, clinical development, and external innovation. Jim joined Janssen in 2014.

Prior to joining Janssen, James served with Bristol-Myers Squibb as Vice President, Diabetes Development with responsibility for the diabetes joint venture alliance with AstraZeneca.

Earlier in his career, James was a faculty member of the Harvard Medical School in Cambridge, Massachusetts with clinical responsibilities in General Endocrinology and Thyroid. He graduated from Stanford University in Stanford, California and completed his M.D. and Ph.D. from the University of Minnesota in Minneapolis, Minnesota. He completed his medical training at Brigham and Women’s Hospital, Boston Children’s Hospital and the Massachusetts General Hospital, and is board certified in Internal Medicine, Pediatrics and Endocrinology.

James List, M.D., Ph.D.

Global Therapeutic Area Head, Cardiovascular & Metabolism



Husseini K. Manji, MD, FRCPC is Global Therapeutic Head for Neuroscience at Janssen Research & Development, LLC, one of the Johnson & Johnson pharmaceutical companies. He is also Visiting Professor at Duke University. Dr. Manji was previously Chief of the Laboratory of Molecular Pathophysiology & Experimental Therapeutics at the National Institutes of Health (NIH) and Director of the NIH Mood and Anxiety Disorders Program, the largest program of its kind in the world.

The major focus of Dr. Manji’s research is the investigation of disease- and treatment-induced changes in gene and protein networks that regulate synaptic and neural plasticity in neuropsychiatric disorders. His work has helped to conceptualize these illnesses as genetically-influenced disorders of synaptic and neural plasticity and has led to the investigation of novel therapeutics for refractory patients. Notably, Dr. Manji’s research demonstrated that AMPA- and NMDA-mediated synaptic plasticity may underlie the pathogenesis of depression, and that targeting these pathways may produce robust and rapid antidepressant effects. Under his leadership, this has led to the FDA Approval of the first novel antidepressant mechanism (NMDA-antagonism) in decades. Spravato (an NMDA antagonist) was demonstrated to produce robust and rapid antidepressant effects and is approved for treatment resistant depression. Phase 3 studies investigating its efficacy in the treatment of suicidal ideation are underway.

Dr. Manji has received a number of prestigious awards, including the NIMH Director's Career Award for Significant Scientific Achievement, the A. E. Bennett Award for Neuropsychiatric Research, the Ziskind-Somerfeld Award for Neuropsychiatric Research, the NARSAD Mood Disorders Prize, the Mogens Schou Distinguished Research Award, the ACNP’s Joel Elkes Award for Distinguished Research, the DBSA Klerman Senior Distinguished Researcher Award, the Briggs Pharmacology Lectureship Award, the American Federation for Aging Research Award of Distinction, the Caring Kind Alzheimer’s Disease Leadership Award, and the Global Health & the Arts Award of Recognition. He has received PhRMA’s Research & Hope Award for Excellence in Biopharmaceutical Research, and has also been recognized as one of 14 inaugural “Health Heroes” by Oprah magazine.

Dr. Manji has been inducted into the National Academy of Medicine (formerly IOM), the World Economic Forum (WEF) Global Future Councils, and has held numerous leadership positions within the NAM, the FNIH Biomarkers Consortium Executive Committee, the ACNP, and the Society of Biological Psychiatry.

Throughout his career, Dr. Manji has also been committed to undertakings related to medical and neuroscience education and has worked with the National Board of Medical Examiners (NMBE), the Howard Hughes Medical Institute Research Scholars Program, and numerous national curriculum committees. He founded and co-directed the NIH Foundation for the Advanced Education in the Sciences Graduate Course in the Neurobiology of Neuropsychiatric Illness, and has received several teaching and mentoring awards. He has also served as Editor, and on editorial boards of numerous scientific journals.

Dr. Manji has published extensively on the molecular and cellular neurobiology of severe neuropsychiatric disorders and development of novel therapeutics, with over 300 publications in peer-reviewed journals, including Science, Science Translational Medicine, Nature Neuroscience, Nature Reviews Neuroscience, Nature Reviews Drug Discovery , NEJM, J Clinical Investigation, PNAS, J Neuroscience, JAMA Psychiatry, Molecular Psychiatry

Husseini K. Manji, M.D., F.R.C.P.C.

Global Therapeutic Area Head



James Merson, Ph.D., is the Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development, L.L.C. He leads a global team focused on continuously creating and progressing transformational medicines to help fight infectious diseases including influenza, respiratory syncytial virus (RSV), HIV and hepatitis B.

James holds more than 25 years of R&D experience in antivirals, vaccines (prophylactic and therapeutic) and immuno-oncology. Previously at Pfizer, Inc., he held a succession of leadership positions including Chief Scientific Officer of the Vaccine Immunotherapeutics Research Unit, co-leader of Infectious Diseases and Head of their Antiviral Therapeutic Area. Throughout his tenure, James led the development of a series antiviral molecules for the treatment of HIV (CCR5 antagonist) and hepatitis C. He also realized the potential of antibacterial macromolecules and the clinical evaluation of novel broad-spectrum antibiotics.

James is committed to exploring new avenues of research in the fight against infectious diseases. In addition to his antiviral expertise, his research has been focused on immuno-oncology and the combination of vaccines, oncolytic viruses and immunomodulators to treat chronic diseases which include various types of cancers.

He holds a Ph.D. in microbiology and immunology from Baylor College of Medicine, Houston, Texas and a B.A. in biology from Bellarmine College, Louisville, Kentucky. He is a member of the New York Academy of Sciences, the British Society of Immunology and the International Society of Vaccines, and has served on several scientific advisory and company boards.

James Merson, Ph.D.

Global Therapeutic Head
Infectious Diseases



Sanjaya Singh, Ph.D., is Global Head, Janssen BioTherapeutics within Janssen Research & Development. Sanjaya is responsible for leading an organization focused on biotherapeutic research, discovery, toxicology, clinical pharmacology and strategic external collaboration. In this role, Sanjaya drives the strategy and overall vision to expand and apply the capabilities of Janssen Research & Development to the discovery and development of protein, peptide and cell-based therapeutics.

Sanjaya is an accomplished scientific and business leader with more than 25 years of industry and academic experience. Prior to joining Johnson & Johnson, Sanjaya spent nine years at Boehringer Ingelheim, most recently serving as Vice President, Biotherapeutics Discovery. During his tenure, Sanjaya led a global team responsible for building a competitive and productive pre-clinical and clinical biotherapeutics pipeline. He has successfully led the identification of therapeutic targets in the field of immunomodulation and has developed biologic molecules in the fields of immunology, oncology, ophthalmology, cardio-metabolic and infectious disease.

In the realm of academia, Sanjaya held a faculty position in the Department of Molecular Biology at the Institute of Life Sciences in India. An author of numerous peer-reviewed articles, Sanjaya also is co-author on more than 25 patents.

Sanjaya earned a Ph.D. in Molecular Biology from Banaras Hindu University, Varanasi, Uttar Pradesh, India. He served as a Postdoctoral Fellow in the Department of Molecular Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas, and as a Research Associate in the Department of Biochemistry and Molecular Biology, also at MD Anderson Cancer Center in Texas.

Sanjaya Singh, Ph.D.

Global Head
Janssen BioTherapeutics


Global Head
Product Development & Supply
Janssen Research & Development

Richard Tillyer, Ph.D, is Global Head, Discovery, Product Development & Supply, Janssen Research and Development. In this role, he leads an integrated discovery, process development and clinical supply organization that comprises all modalities including small molecules, traditional and non-traditional single molecule biologics, and larger, more complex multicomponent biologics including RNA, viruses and cells.

Rich joined Janssen in 2018 from Merck & Co (MSD outside the United States), where he acquired extensive experience in all stages of drug discovery and product development across numerous therapeutic areas and modalities. During his 25-year tenure, he led large and varying aspects of Merck Research Labs, including Process Chemistry, Toxicology, Drug Metabolism and Pharmacokinetics, Formulation, Biologics and Vaccines Process Development, High Throughput Screening, Discovery Biology, Medicinal Chemistry, Computational Chemistry and various platform groups. Under his leadership, Rich’s teams contributed to the discovery and development of most major products introduced by Merck over the last two decades and significantly advanced the company’s current pipeline. He led or actively contributed to major strategic initiatives including large and small-scale mergers and R&D integrations (most notably, the integration of Schering-Plough announced in 2009).

Rich obtained his Ph.D. in Chemistry from the University of British Columbia, Canada, and a post-doctoral research fellowship in Chemistry from the University of Cambridge, UK. He has published more than 70 scientific articles and publications and he holds several patents.

Richard Tillyer, Ph.D.

Global Head
Product Development & Supply
Janssen Research & Development



As head of the Global Regulatory Affairs (GRA) within Janssen Pharma, Karin Van Baelen leads an organization of approximately 900 highly qualified colleagues who foster relationships with Health Authorities around the world and deliver innovative healthcare solutions to patients. Under her leadership, the GRA organization influences and interprets global regulatory requirements and enables our company to meet those guidelines. In addition, GRA oversees the development of regulatory strategy for products from all therapeutic areas, as well as the delivery of high-quality, on-time regulatory submissions and approvals. GRA also engages in policy development at national and international levels in the regulatory, biotechnology and clinical development arenas

Previously, Karin served as Vice President of Regional Regulatory Affairs and Global Regulatory Operations, leading activities in Europe, Middle East, Africa, Russia (EMEA), Asia Pacific and Latin America and overseeing the Labeling & Submissions Management organization.  From 2008 to 2013, she led the EMEA Regional Regulatory Affairs team in all regulatory aspects for all therapeutic areas and all operating company regulatory organizations in the region. Karin also served as Vice President of Global Regulatory Affairs for Tibotec BVBA where she created and led its global regulatory team and contributed to the development and approvals of several products in the Janssen Infectious Diseases & Vaccines portfolio. She also worked with GRA at the Janssen Research Foundation and was responsible for the worldwide registrations of several key products, including medications for severe mood disorders and pain. Karin joined Johnson & Johnson in 1993 from Upjohn Benelux where she submitted numerous Marketing Authorization Applications and obtained approvals in Europe and emerging markets.

Karin has a strong record of developing successful leaders and served as the EMEA Diversity & Inclusion regional champion.

Karin obtained her Doctor of Pharmacy (Pharm.D.) degree at the University of Antwerp, Belgium in 1988. Karin serves with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Scientific Regulatory & Manufacturing Policy Committee (SRMPC) and with the Pharmaceutical Research and Manufacturers of America’s Regulatory Affairs Coordination Committee (RACC). 

Karin Van Baelen, Pharm. D.

Head, Global Regulatory Affairs



Johan Van Hoof, M.D. received his medical degree (cum laude) from the University of Antwerp, Belgium, in the Department of Anatomy and Embryology at Rijksuniversitair Centrum Antwerpen, Belgium. He studied business management at Krauthammer International School and the International Executive Programme INSEAD, Fontainebleau, France.

Johan joined the Johnson & Johnson Family of Companies in April 2005 as Vice President, Data Management and Early Clinical Development. Following roles as Chief Operating Officer (COO) of Johnson & Johnson Pharmaceutical Research, LLC, and Head of the Global Development Organization, he was appointed Global Therapeutic Area Head for Infectious Diseases & Vaccines in 2010. Since 2011 he has been overseeing research & development at Janssen Vaccines as Managing Director.

Before joining the Johnson & Johnson Family of Companies, Johan acquired more than 20 years of experience in the vaccine industry, having worked with Pasteur Mérieux Connaught, Chiron Vaccines and GlaxoSmithKline (GSK) Biologicals. During this period, he held leadership roles with increasing responsibilities, including Head New Product Development at GSK Biologicals. Johan was actively involved in the development and licensing of a new generation of childhood and adult vaccines in disease areas such as pertussis (pediatric combined vaccines), meningitis, rotaviral diarrhea, hepatitis, flu and HPV.

Johan Van Hoof, M.D.

Global Therapeutic Area Head
IDV, Vaccines
Managing Director
Janssen Vaccines and Prevention, B.V.