Linical Scientific & Medical Leadership
Linical's commitment to providing quality services starts with our people. Our team members are passionate about their work and are dedicated to fulfilling each client's requirements in a timely, accurate, well managed and cost-effective manner.
Meet our regulatory and medical leaders at Linical Americas, working hard to make your clinical projects successful. Our subject matter experts have decades of industry experience and are here to be an extension of your team.
Tracy Goeken, MD, Chief Medical Officer
As Chief Medical Officer of Linical Americas, Dr. Goeken is responsible for providing strategic and operational leadership regarding the Company’s Medical and Scientific Operations. Dr. Goeken oversees clinical development functions and activities within the company including Medical, Regulatory, Medical Writing and Pre and Post Market Pharmacovigilance departments ensuring global alignment and operational excellence. Dr. Goeken received his M.D. from St. Christopher’s College of Medicine in the UK, having completed his clinical training at LSU Health Sciences Center in Louisiana and Sub-Internship in High Risk Maternal Fetal Medicine at Ochsner Clinic Foundation in Louisiana. Prior to joining Linical, Dr. Goeken held positions at The Methodist Hospital Research Institute in Houston, Texas, Pharm-Olam International, Nuron Biotech and Somahlution. Dr. Goeken has substantial global experience with clinical development and medical affairs functions leading global product development efforts from first in man/proof of concept through pivotal study, product launch and beyond. He is experienced with multiple therapeutic indications across drug/biologic and medical device platforms.
Joan Drucker, MD, Medical Director & Medical Monitor
Dr. Joan Drucker is an infectious disease and vaccines expert, with more than 30 years in academic and pharmaceutical medicine investigating new drugs, biologics, and devices across multiple therapeutic areas. As Medical Director and Medical Monitor at Linical Americas, Dr. Drucker provides expert medical and scientific training to project teams, as well as oversight of protocol compliance and patient safety. Before Linical Accelovance, Dr. Drucker held a number of executive positions within the clinical development industry, including: Vice President, Medical Strategy; Global Head, Infectious Diseases and Vaccines Center of Excellence for IQVIA, Chief Medical Officer for Accelovance, an independent medical and strategic consultant to pharmaceutical and biotechnology companies, and Chief Medical Officer for Trimeris, Inc. Additionally, Dr. Drucker served for 12 years at Burroughs Wellcome/GlaxoWellcome where she directed Phase I-IV antiviral and infectious diseases clinical research in both US and international medical affairs. Dr. Drucker is a board-certified internist licensed to practice in North Carolina, and a former faculty member in infectious diseases at Duke University Medical School. Dr. Drucker completed her undergraduate work at Harvard University, received her Medical Degree from The University of Virginia, completed her internal medicine residency at Tufts’ Faulkner Hospital, and her infectious diseases fellowship at Duke University.
Joe Purvis, MD, Medical Director & Medical Monitor
Dr. Purvis has more than 30 years of Phase I-IV clinical research experience in medical oncology and hematology. He is a knowledgeable and successful pharmaceutical physician, offering extensive experience in developing and registering numerous anticancer compounds. Dr. Purvis serves as Medical Director and Medical Monitor at Linical Americas, where he provides scientific leadership to ensure successful clinical development of clients’ products and their ultimate approval. Dr. Purvis provides expert medical and scientific oversight to key functional areas including Project Management, Clinical Monitoring, and Data Management. His development experience encompasses a wide variety of compounds, including cytotoxics, hormonal agents, biological agents, and targeted small molecules. Dr. Purvis has a strong background in strategic planning and execution of all phases of clinical development for both US and global regulatory approval. Throughout his career, he has worked closely with regulatory agencies, including the Food and Drug Association (FDA), and European Medicines Agency (EMA), and he has led the management of safety and labeling issues that occur during product development and marketing. In addition to his regulatory background, Dr. Purvis served as a senior Oncologist and Global TA Head for the world’s largest CRO.
Harish Dave, MD, Oncology Therapeutic Lead
Dr. Dave is the Global Oncology Therapeutic Lead for Linical Americas. Dr. Dave has 25+ years of Phase I-IV clinical research experience including the conduct of over a 100 studies with a focus on hematology, oncology and transplantation as well as other areas of internal medicine. Dr. Dave provides integrated drug development and therapeutic advice, management of clinical trials, and expertise and due diligence for biotech, small, medium and large pharma and VC companies. He has scientific expertise in gene regulation, gene therapy and tumor immunology; clinical and academic expertise in hematology including coagulation disorders, oncology and transplantation; and industry experience in hematology/oncology drug development from pre-clinical to phase IV space and in biosimilars/biobetters and immunotherapeutics. Prior to joining Accelovance, Dr. Dave held positions at Quintiles, George Washington University Medical Center and VA Medical Center in Washington, DC and NIH in Bethesda, MD. Dr. Dave holds a MB, ChB from the University of Sheffield and a MBA from the TRIUM program (jointly awarded by NYU, London School of Economics and HEC).
Steven Castillo, Director of Regulatory Affairs
As Director of Regulatory Affairs, Mr. Castillo supports clients' regulatory submissions and strategy, as well as FDA correspondence. He has over 26 years of experience in Clinical Development and Regulatory Affairs that extends across academia, small biotech, large pharma, global CROs, and niche consulting. From October 2014 to January 2016, Mr. Castillo served as Vice President, Product and Clinical Development at Camargo Pharmaceutical Services, LLC. Prior to that he was the Global Project Head III, Retina Drugs and Biologics, at Alcon, a Novartis, Co. from 2012 to 2014. From 2007 to 2012, Mr. Castillo was Director of Clinical Development at Argos Therapeutics and then at the Global CRO PPD as Director of Global Product Development in the Regulatory Affairs Dept. From 1996 to 2006, Mr. Castillo held various positions of increasing responsibility at Glaxo Wellcome and GlaxoSmithKline in the Infectious Disease group leading clinical development teams. Career accomplishments have been noted by the global approvals of once-daily lamivudine, once-daily abacavir, once-daily abacavir/lamivudine combination, and ocriplasmin. In addition, Mr. Castillo has led and/or participated in numerous FDA Pre-IND, Type B, EOP2, and Pre-NDA meetings across many divisions of the FDA. Mr. Castillo received his Master of Science degree from University of Washington – Seattle, in Molecular and Cellular Biology under a Pre-Doctoral NIH fellowship grant and a baccalaureate degree from the University of Colorado – Boulder, in Biology.