Management Team

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Europe

Karen Barker

Senior Vice President, Europe

Karen Barker has more than 30 years of experience in the pharma, biotech, and CRO industries at companies including PRA, INC, and Omnicare. Karen has an extensive strategic, operational, and financial track record managing Clinical Operations, Project Management, and Study Start-Up within complex matrix environments throughout Europe and Asia-Pacific.

An exceptional people manager with a very loyal following, Karen can quickly and effectively build and maintain stable, high-performing teams, generating solid operational and financial performance. She has successfully managed numerous company integrations and mergers, ensuring project, departmental, company, and employee continuity and growth.

Karen is responsible for Premier Research’s business in Europe focusing on customer, community and employee engagement. She has a specific interest in oncology and is an active member of the PharmaTimes International Steering Committee and an oncology patient advocacy group.

Strategy

Nach Davé

Vice President, Development Strategy

Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of experience in the pharmaceutical and contract research industries to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both CROs and sponsor companies.

Mr. Davé previously led clinical and regulatory affairs at Maxx Orthopedics, a developer of orthopedic medical devices, and has held roles in clinical operations, business development, strategic consulting and medical affairs at companies such as Merck, Bristol-Myers Squibb, Aventis Pharmaceuticals and Mitsubishi Pharma America.

In his current role, Mr. Davé brings innovative solutions and grow Premier’s footprint in the areas of medical device development, real-world evidence, and government relations. He is keen to explore how innovative technology like AI, ML, and other developments can best support the growth of Premier’s business.

Mr. Davé holds a master’s degree in drug regulatory affairs from Long Island University and a bachelor’s degree in pharmacy from the University of Sciences-Philadelphia. He is a registered pharmacist.

Statistical Consulting

Abie Ekangaki

Vice President, Statistical Consulting

Abie Ekangaki is responsible for providing strategic planning, coordination, knowledge, and expertise in biostatistics for projects and/or standalone consultative services for both internal and external clients. He supports the Business Development and Operations efforts for key customers to design and manage effective and efficient clinical trials/programs bringing specific statistical, drug development, and operational knowledge in the respective area of focus.

With more than 20 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has held several technical and senior leadership positions in the pharmaceutical industry. Given his more than 17 years in the pharmaceutical industry. He is experienced at applying and advising on the statistical design and analysis of clinical trials in various therapeutic areas, from proof of concept and beyond.

Dr. Ekangaki received his PhD in statistics from the University of Southampton, UK.

Medical Device & Diagnostics

Vicki Gashwiler

Executive Director, Medical Device & Diagnostics

Vicki Gashwiler joined Premier Research in 2019 as the executive director of strategic development in the Medical Device & Diagnostics group. She brings over 20 years of health care experience and 15 years of experience in the medical device industry, both on the sponsor and CRO sides. Prior to her industry experience, Vicki began her career as a registered nurse in 2000, working on cardiac, critical care and out-patient orthopedic surgical units. She started her industry career as a clinical research associate at Abbott Vascular and had the opportunity to advance in the operations group as a clinical trial manager and then as a project manager. During her time at Abbott Vascular, Vicki supported global clinical trials spanning across Europe, Canada, Latin America, Australia, the US and the Asia-Pacific. Her time at Abbott provided her an extensive understanding of complex trial execution on a global scale, diverse team management and global regulatory processes and timelines.

In 2014, Vicki joined Novella Clinical in a project manager role, gaining experience on the vendor side of clinical trial delivery. She filled roles of increasing responsibility while at Novella, including senior project manager, program director, associate director, and director of Strategic Development & Market Access. During her time at Novella, Vicki gained experience in oncology and dermatologic devices, endocrinology, weight management, orthopedics, as well as additional cardiac and vascular device trials. Vicki brings a high level understanding of market development and trends as well as a deep therapeutic knowledge of many disease processes and the clinical trials to intervene upon them.

Oncology

Luke Gill

Vice President, Oncology

Luke Gill has an extensive scientific background and more than 20 years of drug development experience. Specializing in oncology, he has led numerous global CRO management teams and provided strategic assessment, management, and oversight of study enrollment and program metrics.

Prior to joining Premier Research in 2015, Mr. Gill was Director of Global Project Management for Hematology and Oncology at PPD, overseeing design and delivery of clinical development plans across multiple indications and specializing in early-phase oncology. He also served as Assistant Project Management Director at PPD, was CRO alliance program director for Merck Serono, and has held positions at Pfizer/Parke Davis, Astra, and Glaxo.

Mr. Gill holds a master’s degree in neuro and molecular pharmacology from the University of Bristol, a bachelor’s degree in biological sciences from the University of the West of England, and an MBA specializing in strategy and international enterprise from the Open University in the U.K.

Asia-Pacific

Ashish Jain

Vice President, Asia-Pacific

Ashish Jain has more than two decades of clinical research experience in India, Singapore, and the U.S. Ashish is responsible for Premier Research’s business in Asia-Pacific region and ensuring company’s continuous expansion, smooth project delivery and customer satisfaction. Mr. Jain is also responsible for commercial opportunities in the Asian market and established a Premier Research corporate support services center in Asia.

Mr. Jain has vast experience in creating and implementing business strategies, effectively managing human resources, developing effective customer relationships, and managing financial plans. He has set up new clinical research units and built businesses across Asia Pacific, acquired companies, and integrated businesses across continents.

Strategic Development

Michael King Jolly

Senior Vice President, Strategic Development

Michael King Jolly joined Premier Research in 2016 to oversee strategic drug development partnerships and to implement innovative technologies and alliances. He has more than 35 years of clinical research and drug development experience, having held senior positions in strategic partnering, medical and regulatory affairs, clinical operations, and R&D at some of the industry’s leading companies.

Dr. Jolly holds a Doctor of Pharmacy degree from the University of Texas-Austin and a bachelor’s degree in zoology from the University of North Carolina-Chapel Hill, and is a graduate of the Burroughs Wellcome Management Institute. He teaches at the School of Pharmacy at the University of North Carolina-Chapel Hill.

Analgesia

Michael Kuss

Vice President, Analgesia Product Development

Michael Kuss, Vice President, Analgesia Product Development, leads an experienced group of scientific and regulatory professionals who provide sponsors with end-to-end support throughout their analgesia product development. Premier Research has developed multiple proprietary pain models that minimize the variability of subjective responses to pain, and that have become industry standards for analgesia research.

Prior to joining Premier Research, Mr. Kuss worked for Pharmacia (formerly G.D. Searle) in various positions with the last being Director of Research and Development. He was responsible for clinical development of several COX-2 inhibitors (celecoxib, valdecoxib and parecoxib) and NSAIDs (oxaprozin, oxaprozin potassium, diclofenac/misoprostol) as part of the Arthritis and Inflammation team. Prior to G.D. Searle, Mr. Kuss worked as a Clinical Research Associate at Abbott Laboratories and as an Infectious Diseases Research Technologist.

Mr. Kuss holds a bachelor’s degree in medical technology from Wright State University in Dayton, Ohio. He received a certification in medical technology from the American Society of Clinical Pathology.

Biometrics

Shari Medendorp

Senior Vice President, Biometrics

Success hinges on the ability to create actionable information, so Shari Medendorp works closely with our biostatistics team to turn raw data into knowledge that drives decisions and fuels the progress that moves new products forward. Information delivery is customized to the customer and project to ensure a highly individualized level of service.

Before coming to Premier Research, Ms. Medendorp held data management positions at CliniRx USA Inc., Reliance Clinical Research Services, and SCIREX Corporation. Prior to that, she worked with medical staff at the Cleveland Clinic Foundation on the design and analysis of clinical studies. Ms. Medendorp holds a master’s degree in public health from the University of Michigan at Ann Arbor and a bachelor’s degree in mathematics from Calvin College in Grand Rapids.

Analgesia

Scott Millard

Vice President, Analgesia

Scott Millard has spent his 25-plus year career focused in analgesia study delivery overseeing the strategy through to execution for analgesia programs. Mr. Millard’s leadership of the analgesia business and study execution expertise is the perfect pairing to provide sponsors with clean data that can be used confidently to support the marketing applications for their drugs in development.

Since joining Premier Research, Mr. Millard has served in a variety of roles with increasing scope and responsibility, including Senior Clinical Research Associate, Team Lead, Senior Manager, Project Manager, Senior Project Manager, Project Director, Senior Director, Executive Director, and Vice President. Mr. Millard served at a director level managing project managers and sponsor programs, specializing in analgesia and rheumatology.

Mr. Millard has a bachelor’s degree from the University of Texas and was certified as a Certified Clinical Research Associate in 1995 by the ACRP.

Regulatory Affairs

Kristi Miller

Head of Global Regulatory Affairs Strategy, RPI, a Division of Premier Research

Kristi Miller leads a diverse, cross-functional team of regulatory affairs professionals at RPI, A Division of Premier Research, to develop and implement global regulatory strategy in conjunction with clients across all stages of development and therapeutic areas, including neurology, immunology, and oncology. Prior to joining RPI, Dr. Miller was the Director of Global Regulatory Affairs at Phamacyclics and previously spent 10 years at Genentech in regulatory affairs, providing regulatory leadership and executed strategy for products across development (pre-IND through post-marketing), including indications in asthma and ophthalmology.

Dr. Miller holds a bachelor’s degree in genetic engineering from Cedar Crest College and a Ph.D. in tumor cell biology from Northwestern University.

Patient and Stakeholder Engagement

Juliet Moritz

Vice President, Patient and Stakeholder Engagement

Juliet Moritz has worked in clinical research for more than 30 years, and her extensive background covers the spectrum from single-site studies to large, multinational trials. She joined Premier Research in 2016 to specialize in rare diseases, supporting the strategic development of products that address unmet medical needs associated with rare and orphan afflictions.

Ms. Moritz’s role as Vice President, Patient and Stakeholder Engagement, combines her deep clinical development experience with her passion for patient-centric research. She is responsible for development of patient-centric processes throughout Premier’s services offerings.

Ms. Moritz holds a master’s degree in public health from the Drexel University School of Public Health and a bachelor’s degree in biology from the University of Pennsylvania. She is currently pursuing her doctorate in bioethics through Albany Medical College and is completing the Stanford Professional Certificate in genetics and genomics.

Clinical Monitoring

Melissa Nezos

Global Head, Clinical Monitoring Services

Melissa Nezos has worked for over 20 years in a number of global Clinical Research Organizations within Clinical Operations and Project Management. During her career, Ms. Nezos has held both operational and senior management positions from Project Manager to Director, eClinical Solutions. In recent years, she has brought her extensive clinical knowledge and expertise into the risk-based monitoring and risk-based quality management solutions environment and been invited to speak at multiple conferences to present in these areas.

Recognized within the industry as a champion for progression, Ms. Nezos has been instrumental in delivering organizational change initiatives. In addition, she has been an Executive Steering Committee member for the Clinical Researcher of the Year competition for multiple years, advocating progression and excellence within the industry, as well as being active in ACRP initiatives that promote positive change within the industry.

As an advocate for data-driven and technology-led solutions, Ms. Nezos has leveraged her ability to work across operational functions to successfully implement innovative clinical monitoring and data quality strategies. Melissa holds a Master degree in Neuropsychology, specializing in Alzheimer’s Disease and Traumatic Brain injury research.

Rare Disease & Pediatrics

Angi Robinson

Vice President, Rare Disease & Pediatrics

Angi Robinson has been conducting pediatric and rare disease studies at Premier Research for more than 15 years. She has provided oversight and full management support for over 30 rare disease studies, including multiple U.S. and global programs. She has also supported FDA pre-IND meetings, IND submissions, and NDA/BLA project directorship.

Ms. Robinson helped launch the first Best Pharmaceuticals for Children Act Coordinating Center, collaborating with leadership staff at NICHD. She served as the Project Manager for highly complex trials including pediatric sedation in the PICU and pediatric bipolar disorder. Ms. Robinson’s experience includes multiple study designs including PK/PD, adaptive design, and FDA fast track and breakthrough therapy designations. She has also directed several studies requiring the oversight of data safety monitoring boards and data monitoring committees.

Ms. Robinson earned a bachelor’s degree in cell and molecular biology from Tulane University in New Orleans, LA.

Clinical Operations

Susan Romberg

Senior Vice President, Clinical Operations

Susan Romberg brings deep industry and therapeutic experience to her role overseeing global monitoring, clinical management, and document management, having held numerous senior positions in operations and project management in the contract research field.

Ms. Romberg worked in clinical research for more than 20 years prior to joining Premier Research, most recently serving as Vice President of Global Clinical Development at Chiltern International. She previously was Global Vice President of Project Operations at ReSearch Pharmaceutical Services, Vice President of Clinical Operations for the Americas at PRA International, and Executive Director at Clinsys Clinical Research Ltd., among other executive roles. She began her career as a clinical scientist at Astra Merck.

Product Development

Sameena Sharif

Senior Vice President, Product Development, RPI, a Division of Premier Research

Sameena Sharif is Senior Vice President of Product Strategy at RPI, A Division of Premier Research. With more than 20 years of industry experience, Sameena has extensive experience in managing complex drug development projects and programs ranging from early target identification to NDA/MAA and launch. Her experience covers biologics, small-molecule drug development, and portfolio management. She was the Project Lead for multiple development programs, seeing them from Phase 1 through to Phase 3, in oncology, hematology, and inflammatory disease.

Dr. Sharif is a skilled project manager who functions effectively in matrixed environments in both established and virtual teams. She built a pharma start-up from the ground up and has formed and led cohesive, highly productive teams within organizations and jointly with customers. Prior to joining RPI, Sameena was a senior executive for several small pharma/biopharma sponsors, including QED Therapeutics, Astex Pharmaceuticals, Cellerant Therapeutics, Exelixis, PDL Biopharma, Abgenix, and Aradigm, specializing in oncology, hematology malignancies, inflammatory disease, pain, pediatric achondroplasia, cell therapy, and rare diseases.

She has a bachelor’s degree in pharmacy from the University of Bradford and a Ph.D. in pharmaceutical drug development from the University of Nottingham, and completed vaccine development post-doctoral research at the School of Pharmacy, University of Nottingham.

Clinical Informatics

Stacy Weil

Senior Vice President, Clinical Informatics

Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP and held prior roles in leadership in the process improvement, data analytics, learning services, and project management groups at a large, global CRO.

Ms. Weil’s operations experience includes project management and therapeutic leadership in endocrine/metabolic, immunology, urology, women’s health, neuroscience, respiratory, and urology. Her trial oversight includes global and domestic trials and teams in the U.S., Canada, Latin America, Asia-Pacific, and the European Union. She holds a master’s degree in biomedical informatics from the University of Texas-Health and is currently working toward a doctoral degree in health informatics through the University of Texas-Health.