Jim Baker, Chief Executive Officer
For more than 25 years, Jim Baker has directed the fast-paced growth of Ockham as the company created innovative solutions for serving the pharmaceutical and biotech industries. From its beginnings in 1986 as ASG, Inc., Mr. Baker has transformed the company from a clinical resourcing firm to a CRO managing oncology trials around the globe.
Through strategic acquisitions and a commitment to building a strong management team, Mr. Baker created two complementary businesses serving the clinical research industry. As CEO he has also promoted an entrepreneurial culture that encourages individual accountability and ensures that clients have access to company leaders.
Ockham’s two operating divisions feature an oncology CRO and a global resourcing firm. A clinical research organization with an international footprint, Ockham Oncology provides cancer-focused expertise to lead trials with guidance from distinguished scientific and medical teams. Ockham Source provides nationwide Functional Service Provider (FSP) and resourcing solutions for the dynamic clinical industry.
Ockham has been recognized for its growth and innovation. The company was named to Inc. Magazine’s Inc. 500 for three consecutive years, 1996 to 1998. The company also earned recognition as a Triangle Fast 50 in 1997 and 1998 and again in 2009 and 2010. Mr. Baker was a finalist for Young Entrepreneur of the Year in 1997 and 1998.
A long-time community leader, Mr. Baker is an active participant at The Diocese of Raleigh, St. Michael’s Parish and the Durham Nativity School. He is a supporter of industry education and leadership programs.
Prior to Ockham, Mr. Baker worked at Georgia Pacific Corporation. He received a B.A. in Economics from Villanova University.
Bill Donovan, President, Ockham Source
As President of Ockham Source, Bill Donovan oversees strategy and business development for the company’s global sourcing division and directs its marketplace positioning and global identity.
A senior Ockham executive, Mr. Donovan served as Vice President of Global Business Development before becoming President of Ockham Source. He provided global oversight for key clients across all Ockham business units and functions, and served as liaison between Ockham internal operations and decision-makers at client companies.
Among his major accomplishments at Ockham Source is the creation and launch of the Functional Service Provider (FSP) group. One of the company’s most successful operations, the FSP group provides customized resourcing solutions for major clients.
A speaker at industry conferences, Mr. Donovan’s efforts to assist clinical research professionals in building detailed career plans has made him a thought leader within the staffing industry.
For more than 25 years, Mr. Donovan has successfully managed technology companies and directed technology sales and consulting teams. He created Intellicisions Data, Inc., an outsourcing consulting organization, and previously directed the professional services group for Sapiens International. He has also been recognized for sales achievements and leading business development at Hewlett-Packard, DePuy, Inc., and IBM. Throughout Mr. Donovan’s career, he has demonstrated a consistent commitment to community leadership and service.
Mr. Donovan holds a B.A. in Finance from The George Washington University in Washington, D.C.
Michael Enright, President, Ockham Oncology
Michael Enright joined Ockham in 1995 where he held the role of Chief Financial Officer until 2011 when he became President of the CRO group, Ockham Oncology.
Since his appointment as President, Mr. Enright has charted the company’s growth as the premier oncology-focused CRO in the world. In early 2012, he facilitated the strategic acquisition and global integration of Nexus Oncology in Europe and North America. In his previous executive role with Ockham, Mr. Enright led the company’s expansion into Canada and entry into India.
Prior to coming to Ockham, Mr. Enright managed employee benefit administration with Hauser Insurance Group and served as an underwriter for The Prudential Insurance Company. Mr. Enright also worked in financial management with General Electric’s aerospace business group.
Mr. Enright earned an M.B.A. from the University of North Carolina at Chapel Hill and a B.A. in Business Administration with a concentration in Finance from Villanova University.
He also serves on the board of directors at Cornerstone Therapeutics (NASDAQ: CRTX), a specialty pharmaceutical company.
He is based at Ockham’s global headquarters in Cary, North Carolina.
Chris Clark, Chief Financial Officer
An experienced financial leader and strategist, Chris Clark became Chief Financial Officer of Ockham in 2012 following the company’s acquisition of Scotland-based Nexus Oncology.
Mr. Clark joined Ockham following his tenure as Finance Director of Nexus Oncology. He has extensive experience in the European financial markets, working in corporate finance with a focus on equity fundraising, acquisition and disposal mandates and due diligence assignments primarily within the U.K. SME market.
Mr. Clark has held strategic financial roles with DC Consulting Ltd., Springfords LLP and Ardana PLC, all based in Edinburgh, Scotland. Mr. Clark trained with Ernst & Young in the early part of his career before joining Ardana PLC, a start-up specialty pharmaceutical business in 2003.
As Financial Controller at Ardana PLC, Mr. Clark supported the company through a number of private funding rounds and helped direct its successful listing on the London Stock Exchange in 2005 and subsequent placing and open offer in 2007.
Mr. Clark graduated with an M.A. with Honours in Economic Science and Management from the University of Aberdeen (U.K.). He is based at Ockham’s world headquarters and lives in Cary, North Carolina, with his young family.
Clare Wareing, Ph.D., Chief Scientific Officer
Ockham Oncology’s Chief Scientific Officer, Dr. Clare Wareing, provides clinical leadership for the company, advising sponsors on trends in oncology drug development. She also leads the company’s Scientific Advisory Board.
As founder of Nexus Oncology, Dr. Wareing played a key role in the integration of the new company and retains her focus on helping biotech companies develop and bring to market novel oncology agents.
Her extensive industry experience in numerous types of cancer programs includes melanoma, breast cancer, colorectal cancer, CLL, and prostate cancer. Dr. Wareing has also been involved in the research supporting successful registration of agents such as CAMPATH®, Letrazole, Capecitabine, and Abiraterone and Ruxolitinib.
After completing successful undergraduate studies and training in cell biology, Dr. Wareing obtained a Ph.D. at the University of Edinburgh in multi-drug resistance in solid tumors. Moving into oncology drug development in the pharmaceutical industry in 1989, she has held clinical research positions at Astra Zeneca, Roche, Quintiles and ILEX Oncology.
Dr. Wareing represents Ockham Oncology at international scientific conferences and provides strategic advice for clients planning oncology clinical research projects.
Gillian Birnie, Director, Global Quality and Assurance Training
As Director of Global Quality Assurance and Training, Ms. Birnie is responsible for ensuring that all Ockham facilities and systems comply with global regulations governing Good Clinical Practice as well as implementation of internal audit programs. She also oversees global training programs.
Following a successful tenure as Quality Assurance Manager at Nexus Oncology, Ms. Birnie was appointed in 2012 to her broader role overseeing global assurance for Ockham Oncology.
Ms. Birnie began her career in Quality Assurance in 1996 at Inveresk Research (now Charles River Limited) after graduating from Napier University with an honors degree in Biological Sciences. She audited pre-clinical safety studies across a broad range of scientific disciplines and broadened this experience for five years at Quintiles before joining Tower Mains Limited. In this role, Ms. Birnie assumed responsibility for organizing and providing Quality Assurance services to a wide variety of clients requiring audit of both pre-clinical and clinical trials and facilities.
Ms. Birnie is knowledgeable in the auditing of all aspects of clinical trials within a wide variety of therapeutic areas including oncology, asthma (as well as other respiratory trials), gastrointestinal, cardiovascular, pediatrics and virology. Gillian has performed audits in most global regions including North America, Eastern and Western Europe and throughout Asia.
Theresa Bruce, M.B.A, Vice President, Global Operations, Ockham Oncology
As Vice President of Global Operations, Theresa Bruce’s role encompasses general management and leadership of Ockham’s global clinical programs.
Managing an expert staff spanning North America, India, Australia, and Western and Eastern Europe, Ms. Bruce is responsible for supporting biotechnology and pharmaceutical companies for planning and implementation of Phase I through III service. Her team establishes forecasting and operational approaches and leads profitability improvement efforts. In addition, she creates operational metrics and engages Ockham Oncology’s global operations team.
Ms. Bruce and her oncology experts have contributed to Ockham’s successful track record of more than 350 studies in 12 countries since the CRO was launched. She has been with the company since 2006.
Originally trained as a Registered Nurse, Ms. Bruce moved to the clinical research industry in 1992 and has held positions in pharmaceutical companies as well as CROs.
Ms. Bruce earned her M.B.A. at Caledonian University in Glasgow, U.K.
Valentina Zhukova-Harrill, M.D., Vice President, Medical Affairs, Ockham Oncology
A physician with an extensive clinical oncology background and more than 14 years of service to the pharmaceutical industry, Dr. Valentina Zhukova-Harrill has directed more than 120 clinical trials in the United States and internationally. She is a member of the American Society of Clinical Oncology (ASCO).
Her broad experience ranges from Phase I to post-marketing trials in the areas of oncology, gastro-intestinal, CNS, dermatology, ophthalmology, and antibacterial treatment (CRO and Pharma).
Dr. Zhukova-Harrill has successfully served as lead Medical Monitor for numerous oncology trials, consistently meeting reporting deadlines and providing medical, scientific, and regulatory guidance to study teams and sites.
Formerly Director, Clinical Development and Drug Safety for Cellgate, Inc., Dr. Zhukova-Harrill also played a significant research role for more than three years at A.R. Kamm Associates where she served as Director, Clinical Trials Monitoring.
In addition to being certified with the European Medicines Agency (EMA) for EudraVigilance – electronic reporting of Individual Case Safety Report (ICSR) knowledge evaluation – Dr. Zhukova-Harrill has completed a two-year Management and Customer Service Training curriculum through Vital Learning’s Supervision Series of Achievement and annual professional training sessions through the Drug Information Association (DIA) and Barnett International.
Fluent in her native Russian as well as English, Dr. Zhukova-Harrill graduated from Novosibirsk Medical University in 1977 and completed two post-graduate fellowships in Infectious Diseases (1977-1978) and CNS and Psychiatry (1981-1983).
Harman M. Dubé, Ph.D., Vice President, Scientific and Regulatory Affairs, Ockham Oncology
Dr. Harman Dubé draws on more than 17 years of experience developing and directing a variety of drug development programs to support the efforts of biotech and mid-sized pharmaceutical organizations.
Her broad scientific and regulatory affairs experience includes leading oncology non-clinical development programs, creation of clinical development plans and leading and managing Ockham Oncology’s U.S., Canadian and International regulatory filings for drugs and biologics. Dr. Dubé has also led and participated in a number of successful regulatory agency meetings including those designed to discuss non-clinical and clinical development strategies and compound-specific issues.
Prior to joining Ockham Oncology, Dr. Dubé served as the Head of Drug Development at two biotech companies, where she was responsible for the successful transition of compounds from the research laboratory to the clinic. She also spent 10 years at Abbott Laboratories in the U.S., rising through positions of increasing management responsibility in the areas of project management, pre-clinical development and applied research.
Dr. Dubé holds Doctorate and Master’s degrees in Physiology from the University of Ottawa. She earned her Pharmacology undergraduate degree at the University of Toronto.
Gerald L. Messerschmidt, M.D., FACP, Chief Medical Officer, Ockham Oncology
Dr. Messerschmidt is a healthcare leader with broad experience in the clinical development of new therapeutic methodologies. His expertise in research and clinical practice, pharmaceuticals, biologic products, genetic modification of living organisms and immune modulation therapy offer invaluable experience to support Ockham Oncology’s core mission.
Dr. Messerschmidt has extensive clinical and product development experience in start-up, mid-size and large corporate settings. He remains involved with U.S., European, and Japanese regulatory authorities as well as with many other international governing agencies. He regularly provides scientific product presentations during official sessions of these and other agencies.
Triple certified by the American Board of Internal Medicine in Internal Medicine, Medical Oncology and Hematology, Dr. Messerschmidt has completed fellowships at the National Cancer Institute (NCI), Medicine Branch, where he also directed the Experimental Hematology section.
After receiving his M.D. at the University of Oregon School of Medicine, Dr. Messerschmidt completed his Internal Medicine internship at the Kaiser Foundation Medical Center and
During the past two decades, he has interacted consistently with U.S. Food and Drug Administration (FDA) agencies including the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Veterinary Medicine (CVM). Internationally, Dr. Messerschmidt has been closely involved with the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), and European Country Authorities and many other country specific regulatory agencies.
Kathy J. Burruss, Vice President, Biometrics, Ockham Oncology
With more than 25 years experience facilitating data collection, cleaning and reporting, Kathy Burruss is committed to ensuring high data integrity to support critical-path decisions for the drug development industry.
Ms. Burruss has directed or participated in more than 200 Phase I through Phase IV clinical studies, including several global trials ranging from five to 30,000 subjects for wide-ranging therapeutic areas including CNS, oncology, gastroenterology/GI, anti-infectives/HIV, cardiovascular, respiratory, women’s health and orphan illnesses.
While at DuPont Merck, Ms. Burruss led an early electronic sNDA submission resulting in an expedited approval of Naltrexone for the treatment of alcoholism. Additionally, she directed data management teams in pivotal trials leading to successful FDA submissions of drugs and devices for HIV, epilepsy, Hunter’s Syndrome and glioblastoma.
As both an executive and consultant, Ms. Burruss has been instrumental in defining and refining processes and systems across key functional areas in drug development, including validation and implementation of data management systems for Oracle Clinical, Electronic Data Capture (EDC) systems and Clinical Trial Management Systems.
Ms. Burruss leads an Ockham Oncology technical data team with an average of 12-plus years industry experience. She holds a degree in Math/Computer Science from Virginia Commonwealth University in Richmond.
Michael J. Baker, Vice President, Ockham Oncology
Michael Baker has driven the company’s sales and marketing successes during more than 20 years supporting Ockham’s growth, and was a key advisor and contributor during the company’s recent strategic acquisitions.
As Ockham expanded its clinical research focus in oncology, Mr. Baker assumed greater leadership responsibilities to build and manage global client relationships for the CRO. He has provided the sales and marketing leadership for Ockham since 2008 when he began managing the clinical business development function following the acquisition of Ockham Development Group.
Mr. Baker brings substantial team-building skills, an entrepreneurial approach and a commitment to providing excellent client service to his role. In addition to leading the sales and marketing activities at Ockham Oncology, he also oversees all proposals and contracts for Ockham Oncology.
A member of the North Carolina Biotechnology Center, Mr. Baker is also active in the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).
Mr. Baker received a B.A. in Communications from Lynchburg College in 1992.