Company
Ockham's Executive Leadership
Ockham is led by seasoned business and technical professionals with the proven ability to develop new pharmaceutical and biotechnology products in numerous therapeutic areas, run and grow a best-in-class CRO, and manage the demanding technical and business processes involved:
- James V. Baker – Chief Executive Officer
- Joshua S. Baker, Ph.D. – President, Operations
- Valentina Zhukova-Harrill, M.D. – Vice-President, Medical Affairs
- Karen Kuhn, R.N., B.S.N. – Director, Clinical Operations
- Mary Jo Bullard, R.N., B.S.N. – Vice-President, International Operations
- Kathy J. Burruss – Vice-President, Data Management
- Adam C. Gilbert, M.P.H. – Director, Biostatistics
- Michael Enright – Chief Financial Officer
- Bill Donovan – President, OckhamSource™
James V. Baker – Chief Executive Officer
Mr. Baker has over 23 years of experience owning and growing Ockham to provide multiple solutions to the pharmaceutical and biotech industries. Mr. Baker is responsible for Ockham’s strategic planning, execution and overall performance to enhance growth, profitability, productivity, and efficiency throughout the company’s operations. He also provides executive leadership and management of Ockham’s global marketing efforts.
Prior to Ockham, Mr. Baker worked at Georgia Pacific Corporation. He received a bachelor’s degree in economics from Villanova University.
Joshua S. Baker, Ph.D. – President, Operations
Dr. Baker* brings to his leadership post an industry expertise shaped by more than 25 years in pharmaceutical management, drug development, biostatistics, and consulting. In addition to overseeing all operations – including biostatistics, data management, and clinical research – he interacts extensively with Ockham clients and holds full P&L responsibility for the business. In 12 months, he more than doubled Ockham’s revenues.
Dr. Baker earned doctorate and master's degrees in statistics from Texas A&M University and a bachelor's degree in mathematical science from The Pennsylvania State University. Prior to Ockham, Dr. Baker served from 1999 to 2001 as President and CEO of PPGx, Inc. a pharmacogenomics research and development company, where he initiated major academic and commercial collaborations with Duke University and North Carolina State University, and with Aventis Biosciences and PE Biosystems. He also supervised and facilitated development, launch, and commercialization of a Pharmacogenomics Software platform, led creation of a corporate Statistical Genomics Unit, and participated in in-house development and launch of in silico pharmacogenomics activities.
Prior to that, Dr. Baker was Executive Vice-President of Global Operations for PPD Development, Inc., a wholly owned subsidiary of PPD, a leading global CRO. Dr. Baker joined PPD Development in 1994 as Vice-President for Biostatistics, Data Management, and Information Services. A year later, he became Senior Vice-President of Operations, responsible for integration and management of the company's global clinical operations. Under his direction, PPD Development became one of the top four companies in terms of revenue and size in the global clinical research industry.
*No relation to James V. Baker
Valentina Zhukova-Harrill, M.D. – Vice-President, Medical Affairs
Dr. Zhukova-Harrill is the former Director of Clinical Development and Drug Safety for Cellgate, Inc. She is a physician with an extensive background and experience in clinical practice (over 25 years) and pharmaceutical industry (14 years, >30 clinical trials), both in the U.S. and internationally, including Phase I to post-marketing trials in the areas of oncology, GI, CNS, dermatology, and antibacterial treatment (CRO and Pharma).
Prior to joining Cellgate Inc. in 2002, she was employed with A.R. Kamm Associates.
Dr. Zhukova-Harrill 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 DIA and Barnett International.
Her professional responsibilities spanned the direction and oversight of medical, scientific, clinical monitoring, medical writing, safety reporting and regulatory activities within Cellgate.
Dr. Zhukova-Harrill graduated from Novosibirsk Medical University (Russia) in June 1977 and completed two post-graduate fellowships: Infectious Diseases (1977-1978) and CNS and Psychiatry (1981-1983).
Karen Kuhn, R.N., B.S.N. – Director, Clinical Operations
Serving as Director of Clinical Operations from Ockham’s Pennsylvania office for over five years, Ms. Kuhn has 15 years of oncology experience encompassing clinical practice and research in multiple therapeutic areas (head and neck, brain, lung, pancreatic, prostate, breast, renal cell and lymphomas).
Her clinical practice includes staff nursing for all of the following: hematology, oncology and bone marrow transplant. Research experience has also been focused in oncology.
Ms. Kuhn has varied experience working for large Oncology Cooperative Groups that dealt mainly with multi-modality studies. It was during this time that she coordinated multiple brain tumor studies, including two GBM studies. She also brings a sponsor perspective from her previous position at a large pharmaceutical company in which she managed a global oncology study.
Mary Jo Bullard, R.N., B.S.N. – Vice-President, International Operations
Ms. Bullard incorporates numerous skills developed in 15 years of CRO experience to provide integrated functional management to clients’ outsourced management needs. This includes staff training, resource plan development and site training as needed.
Prior to Ockham, Ms. Bullard worked at PPD, Inc., in a broad range of areas including Project Management, Therapeutic Division Management, implementing a global project review and budgeting system, serving as Executive Director of Clinical Operations at corporate headquarters, and developing a Clinical Quality Control process.
Ms. Bullard lends her strong communication and organization skills along with a motivated work ethic to the Ockham management team.
Kathy J. Burruss – Vice-President, Data Management
Drawing on 20 years of experience in data management and analysis programming for the pharmaceutical industry, Ms. Burruss has worked on Phase I through Phase IV studies including several global trials ranging in size from five to 30,000 subjects for various therapeutic areas including CNS, oncology, anti-infectives/HIV, cardiovascular, and respiratory.
Ms. Burruss has served as project manager for several back-end services-only projects including a global Phase III program with a European monitoring component.
Adam C. Gilbert, M.P.H. – Director, Biostatistics
With Ockham since its inception, Mr. Gilbert is distinguished by keen analytic abilities and comfortable, competent communication skills with clients and staffs alike. Before coming to Ockham, he served in academia as a biostatistician for the University of North Carolina’s Collaborative Coordinating Center and co-authored several publications.
Among his duties at Ockham are overseeing operational activities (including staffing, resource projection and allocation, development of departmental processes and documentation, and long-term planning evaluates workloads, resources, process, and technology) and general management of the Biostatistics Department. He also serves as a statistical consultant both internally and externally, and frequently as Lead Biostatistician on clinical studies (Phases I-III).
Mr. Gilbert is experienced in numerous therapeutic areas, including oncology (GBMF, NSCLC, solid tumor, lung, pancreatic, and breast), immunology, cardiovascular, joint, bone and muscle disorders, pulmonology, and ophthalmology. He also has significant pharmaco-kinetic experience and has managed multiple large-scale integrated summary of safety productions for NDA submissions and safety updates.
Michael Enright – Chief Financial Officer
Mike Enright has served as Chief Financial Officer of Ockham since the merger with ASG, Inc., where he held the same position since 1995.
Prior to 1995, Mr. Enright was employed in employee benefits administration with Hauser Insurance Group and as an underwriter for The Prudential Insurance Company. In addition, Mr. Enright worked in financial management with General Electric Company's aerospace business group.
Mr. Enright holds a B.S. in Business Administration (Finance) from Villanova University and an M.B.A. from the Kenan-Flagler School of Business of the University of North Carolina at Chapel Hill.
Bill Donovan – President, OckhamSource™
In his current role, Mr. Donovan is responsible for entire P&L for Ockham’s $20 million clinical sourcing business unit, OckhamSource. In addition, he leads business development and recruiting staffs to meet all performance metrics, and works closely with the management of Ockham’s contract research arm to cross-sell projects to target clients. Among Mr. Donovan’s many accomplishments since the merger is his management of the integration of ASG’s functional outsourcing solution business within Ockham. He was also instrumental in the re-positioning and re-branding of ASG/Ockham business as Ockham.
Since 2009, Mr. Donovan has also provided global oversight for key clients across all Ockham business units and functions, and acts as a liaison between Ockham internal operations (including business development teams) and decision-makers at client companies. Prior to this assignment, Mr. Donovan was Vice-President of Global Business Development for Ockham, focusing on the start-up and growth of the Functional Service Provider (FSP) group.
A veteran of more than 22 years of successful management experience for leading-edge technology companies, he created Intellicisions Data, Inc., a consulting organization that delivers outsourcing services to its clients. As its President and CEO, Mr. Donovan drove strategy and the overall execution of the company’s business.
Prior to founding Intellicisions, Mr. Donovan was Director of Professional Services for Sapiens International, where he oversaw the overall operation and performance of the division. Mr. Donovan drove the formation of the Professional Services Group, which proved to be an essential, strategic component in the growth of the company.
Previously, Mr. Donovan was a Channel Partner Manager for Hewlett-Packard, a Territory Manager for DePuy Inc., and a Senior Sales Representative for IBM. While at these companies, he received numerous awards for sales and territory growth, including being named HP Salesman of the Year as he helped build the largest reseller channel for the HP Medical Technology Division. In addition, he has been widely recognized for community leadership and service.
Mr. Donovan holds a Bachelor of Business Administration in Finance from The George Washington University in Washington, DC.