Joshua S. Baker, Ph.D. –  President and Chief Executive Officer
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 Ockham’s operations – including biostatistics, data management, and clinical research – he interacts extensively with Ockham clients and holds full P&L responsibility for the business. Immediately following his appointment to the role of CEO, Dr. Baker led the company in a reorganization that, in just twelve short months, delivered a doubling in Ockham’s annual revenue.

Dr. Baker earned his 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 as President and CEO of PPGx, Inc. a pharmacogenomics research-and-development company. In that role he initiated major academic and commercial collaborations with Duke University, North Carolina State University, with Aventis Biosciences and with 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 PPGx, Dr. Baker served as Executive Vice-President of Global Operations for PPD Development, Inc., a wholly owned subsidiary of PPD, a leading global Clinical Research Organization. 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 global clinical research organizations in both revenue and global presence.

Valentina Zhukova-Harrill, M.D. – Vice President, Medical Affairs
A physician with more than 25 years of experience in clinical practice and the pharmaceutical industry, Dr. Zhukova-Harrill is the former Director of Clinical Development and Drug Safety for Cellgate, Inc.. In that capacity, Dr. Zhukova-Harrill has supervised more than 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).  While with Cellgate, her professional responsibilities spanned the direction and oversight of medical, scientific, clinical monitoring, medical writing, safety reporting and regulatory activities for the organization.

Prior to joining Cellgate in 2002, Dr. Zhukova-Harrill was employed with A.R. Kamm Associates, where, among other accomplishments, she 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. 

Dr. Zhukova-Harrill graduated from Novosibirsk Medical University (Russia) in 1977 and went on to complete two post-graduate fellowships in Infectious Diseases and CNS and Psychiatry.

Laurie Heilmann – Senior Vice-President, Business Development
Ms. Heilmann joined Ockham in 2005, bringing more than 20 years of experience as a sales professional in the clinical research, healthcare, and information technology (IT) industries. Responsible for the development and execution of Ockham’s global business development strategy, Ms. Heilmann maintains primary contact with key clients – both nationally and internationally.

Prior to joining Ockham, Ms. Heilmann served as a sales executive (including prior vice-president-level positions) with CorResearch, Medical Data Cardiovascular Research Services, Quovadx, PICIS, Cerner Corporation, and Spacelabs Medical. During her 14 year tenure with Spacelabs Medical, Ms. Heilmann held positions as National Sales Director for both the U.S. and Canada.

Gail Robuck, M.P.H. – Vice-President, Clinical Operations
Ms. Robuck serves Ockham clients with more than a dozen years of research implementation and management experience, including nearly three years in a global contract research organization and a decade in an academic setting. Hallmarks of her work are creative, proactive approaches to critical project challenges, including increasing study enrollment rates, effective staff utilization, cost control, automation of data collection, maximization of resources, while delivering completed projects on time and within budget – each time proving herself by successfully managing multiple research studies simultaneously.

Through a successful team-based management style and excellent interpersonal communication skills, Ms. Robuck has managed cross-functional project teams of up to 40 internal staff and six outside vendors. Ms. Robuck has negotiated budgets and managed contracts for study vendors and sites (with budgets ranging from $1.2 million to $36 million.)

In addition, Ms. Robuck brings to bear in-depth training in research methodology, program evaluation, biostatistics and data management, as well as clinical areas of experience that include gastroenterology, diagnostic and therapeutic endoscopy, ophthalmology (AMD), critical care, bone marrow transplant, oncology, obstetrics and gynecology, cardiology, dermatology and vaccines. Ms. Robuck has authored or co-authored numerous publications, presentations, and posters in gastroenterology.

Karen Kuhn, R.N., B.S.N. – Director, Clinical Operations
Serving as Director of Clinical Operations for Ockham’s Pennsylvania office, Ms. Kuhn’s 15 years of oncology experience encompasses clinical practice and research in multiple therapeutic areas, including head and neck, brain, lung, pancreatic, prostate, breast, renal cell and lymphomas.

Her clinical practice background includes staff nursing in hematology, oncology and bone marrow transplant, with additional research experience 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. To this extensive background she brings a sponsor perspective from her previous position at a large pharmaceutical company in which she managed a global oncology studies.

Mary Jo Bullard, R.N., B.S.N. –  Vice-President, International Operations
Ms. Bullard incorporates numerous skills developed over the course of a fifteen year career in CROs, providing integrated functional management to clients’ outsourced management needs. This includes staff training, resource plan development and site training as needed.

Prior to joining Ockham, Ms. Bullard held a variety of roles at PPD, Inc., in a broad range of areas including Project Management, Therapeutic Division Management, implementing a global project review and budgeting system, and served as Executive Director of Clinical Operations at corporate headquarters where she developed a Clinical Quality Control process.

Ms. Bullard lends her strong communication and organization skills along with an un-matched work ethic to the Ockham management team and the company’s clients.

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 been instrumental in Phase I-IV studies. This includes several global trials ranging in size from five to 30,000 subjects for various therapeutic areas ranging from CNS, oncology, gastroenterology/GI  to 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.

Sandra Spears, R.N. – Director, Drug Safety
Ms. Spears came to Ockham with over 17 years in Pharmacovigilance and Regulatory Affairs experience. Moreover, she has more than 22 years of nursing experience and 11 years of management experience, having trained, mentored, and managed numerous Drug Safety/Pharmacovigilance associates throughout her career. She has managed multiple global Phase I-IV clinical trial projects and various post-marketing projects.

Ms. Spears worked extensively on the ARISg Safety Database, initiated database set-up and validation, authored the Data Entry Guidelines, and performed training of database users. She has also served as Global Lead for the Drug Safety project team (Pharma and CRO) that assisted in the successful launch of Coreg, indicated for congestive heart failure, with over 20,000 study participants. Ms. Spears was the main contact with the CRO for safety issues, prepared and presented at Kick-Off and Investigator Meetings, created the global SAE reporting process instructions, attended all project team meetings, worked closely with CRAs, sites, Medical Advisors, Regulatory Affairs, Data Management, Clinical Operations, and Project Management.

Her unique career is enhanced by five years in a broad base of nursing (critical care, emergency trauma, ICU/CCU, cardiac rehabilitation, and pediatric home care.) In addition, Ms. Spears brings to bear significant therapeutic experience in cardiology/cardiovascular, CNS, endocrinology/metabolic, gastroenterology, infectious diseases, oncology, pulmonary, and urology.

Stephen W. Brackett, M.B.A. – Chief Technology Officer / Chief Financial Officer
Ockham’s CTO/CFO has accumulated over two decades of pharmaceutical industryexpertise, including 15 years with GlaxoSmithKline, and two years directing product support for Quintiles. Throughout the course of his career Mr. Brackett has worked in tactical and strategic planning for several facets of the industry, including data management, information technology, project management, and business development. Drawing on this wealth of experience, Mr. Brackett provides strategic direction for information management solutions for Ockham and its clients.

Working with the Ockham Management team, Mr. Brackett develops implementation plans for process and technology improvement and identifies risks and specific actions for mitigation. He also implements tactical and strategic planning for Ockham’s Finance and Business Development activities.

Mr. Brackett earned his bachelor's degree in psychology from the University of North Carolina at Chapel Hill, a post-baccalaureate degree in computer science from North Carolina State University, and a master’s degree in business administration from Duke University.

Adam C. Gilbert, M.P.H. - Director of Biostatistics
With Ockham since its inception, Mr. Gilbert is distinguished by keen analytic abilities and comfortable, competent communication skills with clients and staffers alike. Prior to assuming his responsibilities with Ockham, Mr. Gilbert served in academia as a biostatistician for the University of North Carolina’s Collaborative Coordinating Center and co-authored several publications.

At Ockham, Mr. Gilbert oversees operational activities (including staffing, resource projection and allocation, development of departmental processes, documentation, and long-term planning, evaluates workloads, resources, and technology) along with general management of the Biostatistics Department. He also serves as a statistical consultant both internally and externally, and acts 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, CNS, pulmonology, and ophthalmology. He also has significant pharmaco-kinetic experience and has managed multiple large-scale integrated summaries of safety productions for NDA submissions and safety updates.