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1055 Westlakes Drive

Suite 200

Berwyn, PA 19312

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Management

Complexa has assembled a strong management team with proven in-depth experience in the pharmaceuticals and biotech industry and a track record of success in developing and commercializing medicines to advance novel therapies and transform patient lives.

Chief Executive Officer and President

Chief Medical Officer

Senior Vice President, Technical Operations

Senior Director, Clinical Development

Senior Director, Regulatory Affairs

Director, Finance and Administration

Associate Director, Finance and Administration

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Chief Executive Officer and President

 

Francisco D. Salva serves as Chief Executive Officer and President. He has more than 20 years of experience in corporate development, operations, healthcare venture capital and investment banking. Prior to joining Complexa, Mr. Salva served as a Founder and Vice President of Operations for Acerta Pharma B.V., where he focused on key growth initiatives culminating in a $4 billion investment by AstraZeneca for a controlling ownership interest. While at Acerta Pharma, Mr. Salva was responsible for the company’s financial and operational activities. His responsibilities included deal analysis and negotiations, investor relationships, partnership compliance and financings. Prior to Acerta, he was Senior Director of Corporate Development at Pharmacyclics. Earlier in his career, Mr. Salva spent almost a decade as a life sciences venture capitalist at CIBC Capital Partners, INVESCO Funds Group and Patricof & Co. Ventures. He began his career at Wasserstein Perella & Co.Mr. Salva holds dual Bachelor of Arts degrees in Business Economics and Philosophy from Brown University and a Master of Science degree in Economics (Economics and Philosophy specialty) from the London School of Economics and Political Science.

Chief Medical Officer

 

Theodore (Theo) Danoff, MD, PhD, serves as Chief Medical Officer. He brings more than 20 years of experience in the pharmaceutical industry across all phases of clinical research and drug development with extensive expertise in a range of therapeutic areas, including cardiovascular, endocrinology, urology and neuroscience. Prior to joining Complexa, Theo served as Chief Medical Officer and Senior Vice President of Clinical and Medical Affairs at Clarus Therapeutics. During his tenure with Clarus Therapeutics, Dr. Danoff led the company’s clinical development efforts from Phase 1 to Phase 3 clinical trials, from strategy planning to study execution, NDA submissions, Advisory Committee presentations and FDA approval. Previously, he held senior level positions at Endo Pharmaceuticals where he supervised the overall clinical development of new products within the urology, endocrinology, pain and neuroscience therapeutic areas. While at Endo, he directed the launch of FORTESTA and oversaw the partnered development of BEMA-buprenorphine. He also led the clinical presentation at the Advisory Committee meeting for AVEED that resulted in its NDA approval. Theo began his career in pharmaceuticals at GlaxoSmithKline (GSK), serving in multiple roles of increasing responsibility, he led translational medicine studies to support new and established therapeutic areas. He has been on the faculty at the University of Pennsylvania where his NIH funded research laboratory focused on mechanisms of renal inflammation and fibrosis, and he served as an attending physician at both the Hospital of the University of Pennsylvania and the Veterans Administration Hospital (Philadelphia, PA). Theo received his MD and PhD (Immunology) degrees from the University of Chicago, where he was in the Medical Science Training Program. He completed his nephrology fellowship and residency at the University of Pennsylvania. He has received numerous research awards and has published in a number of peer-reviewed journals. He is board certified in both internal medicine and nephrology. Theo obtained his BS (highest honors) and MS in Chemistry from Emory University.

Mike Nelson

 

Mike Nelson oversees the Project Management and Clinical Operations functions. He has more than 30 years of clinical development and operations experience across prescription and over-the-counter therapies in all clinical phases (1-4) and investigator-initiated studies for major pharmaceutical companies and biotechnology start-ups. Prior to joining Complexa, Mike was responsible for leading Clinical Operations, Sleep Medicine for Jazz Pharmaceuticals, including strategic planning to ensure optimized delivery of Phase 1-4 clinical. He also held management positions at Zalicus Inc., where he was the Vice President of Clinical Operations, overseeing and coordinating activities for a global rheumatoid arthritis program across 12 countries. Mike also held positions with increasing levels of responsibility at Cephalon, J&J-Merck and McNeil Pharmaceuticals. He received his BA at Kutztown University and holds a Master Certificate in Applied Project Management at Villanova University.

Senior Vice President, Technical Operations

 

William Leong, PhD, serves as a key driver of all Chemistry, Manufacturing and Controls (CMC) operations with responsibility for leading formulation development, process development, analytical science and supply chain activities. He also manages all collaborations with experts, from academia to contract manufacturing organizations. He has more than 25 years of CMC experience with a proven record of leadership and success moving product candidates from the laboratory to market. Prior to joining Complexa, William served as Executive Director, Head of CMC for Newron Pharmaceuticals, where he executed integrated strategies for drug substance, product formulation, analytical certification, medical device, clinical supply chain, quality assurance and global regulatory submissions. In addition, he held the position of Senior Director, Head of Process Chemistry at Celgene Corporation, where he directed all operations of the Process Chemistry Department including strategic development for rapid in-house manufacture of new chemical entities. He began his career as a scientist at Schering-Plough Research Institute, where he also held roles of increasing responsibility within the company. William earned a BS degree in Chemistry from the University of San Francisco and a Doctor of Philosophy degree from the University of California, Davis. He completed a post-doctoral research fellowship at Iowa State University, Ames. He has authored several publications and holds manufacturing patents in the United States and Europe.

Senior Director, Clinical Development

 

Rachel Garner serves as a key driver of operational and scientific aspects of clinical development. She has more than 20 years of experience in clinical research and development with specialized expertise in early phase clinical development, technical consultation on strategy, regulations and industry best practices. Most recently, Rachel served as Principal Medical Writer and Program Manager at PPD. Previously, she was Senior Director, Translational Medicine at Cerecor Inc., where she was responsible for managing, designing and implementing Phase 1 and 2 clinical study activities, analyzing and reporting clinical study data as well as managing non-clinical research activities. In addition, she held Director of Clinical Research and Scientific Services positions at Questcor Pharmaceuticals and PARAXEL and was project team leader at Guilford Pharmaceuticals. Rachel began her pharmaceuticals career at SmithKline Beecham as a post-doctoral fellow in Clinical Pharmacology and Drug Development. Rachel earned a BS in Microbiology and PharmD degree from the University of Maryland.

Senior Director, Regulatory Affairs

 

Lester Gibbs, PhD, serves as Senior Director of Regulatory Affairs. He has more than 20 years of experience in regulatory affairs strategy and operations having been actively involved in all stages of drug development, including ensuring compliance with U.S. and global regulations. Lester has broad expertise across a number of therapeutic areas, including infectious disease, oncology, inflammation, pain, dermatology, pulmonology and urology. Prior to joining Complexa, he was the regulatory lead for development-stage infectious disease vaccine programs at Inovio Pharmaceuticals, where he led a number of successful IND submissions and pre-IND interactions with the FDA. Previously, Lester served as Senior Director of Regulatory Affairs at Morphotek. He also held positions with increasing levels of responsibility at Wyeth Pharmaceuticals, Forest Laboratories and Penederm. He received his BS in Toxicology from the Philadelphia College of Pharmacy and Science and holds MS and PhD degrees in Pharmacology and Toxicology from the University of Kansas. He completed a post-doctoral research fellowship at The Albany Medical College and Wadsworth Center for Labs and Research.

Director, Clinical Operations

 

Alexandra Poulos serves as Director of Clinical Operations. She has more than 20 years of experience in clinical research with therapeutic expertise in CNS, cardiology, internal medicine and oncology. Over the course of her career, she has been responsible for strategic and operational management of multiple clinical trials from the pre-clinical stage to Phase IV on a global basis. She also has headed highly successful patient recruitment and retention teams. Prior to joining Complexa, Alexandra served as Manager of Clinical Operations for PRA International, a position she held for eight years in which she oversaw more than 30 direct reports and successfully garnered a high rate of retention. She began her stint with PRA International as Manager of External Partnerships. Previously, Alexandra held positions with increasing levels of responsibility at Actelion Clinical Research, Sanofi-Aventis and Cephalon. During her time with Sanofi-Aventis, she led a successful pediatric exclusivity study for insomnia, enrolling 190 subjects in approximately one month and leading to a 6-month patent extension for the company’s compound, Ambien. Alexandra received her BS degree from Drexel University, an MBA in Pharmaceutical Marketing from St. Joseph’s University as well as an MS in Organizational Development and Leadership from the Philadelphia College of Osteopathic Medicine.

 

Craig Pfister oversees Clinical Operations management of Complexa’s clinical programs. Craig has more than 20 years of experience in global clinical operations management and drug development with proven expertise in operationalizing multi-regional, multi-site clinical programs in collaboration with global teams across R&D departments and with contracted vendors. Prior to joining Complexa, he recently served as Associate Director, Clinical Operations, for Cutanea Life Sciences, a dermatology specialty pharmaceutical company, where he was responsible for clinical strategic and operational management of multiple Phase 1-3 clinical programs. He also held management positions at Celsion Corporation, an oncology-focused biotechnology company, leading the Pivotal Phase 3 trial for its lead indication and worked at Swiftwater Group, a drug development consulting firm. Craig began his career as a Senior Clinical Research Associate at GlaxoSmithKline and diversified his clinical research management experience as a Research Program Manager with the Office of Clinical Research at Temple University School of Medicine. Craig earned a BS degree in Exercise and Sport Science from The Pennsylvania State University.

Director, Finance and Administration

 

David Sinkway manages all financial and administrative operations for the company. He brings a wealth of finance and accounting experience to Complexa in both entrepreneurial start-up and corporate environments. Prior to joining Complexa, he served as Director of Finance for Iroko Pharmaceuticals, where his responsibilities included financial reporting, budgeting/forecasting, and providing analytical and strategic support to senior management and the commercial team. Previously, he was Director of Finance and Administration at Protez Pharmaceuticals, Inc., during which time he led the company’s successful acquisition by Novartis in July 2008. David also held various positions with increasing levels of responsibility within finance and accounting at Destiny WebSolutions; Adaptive Strategies; Spectra Science Corporation and Ecoscience Corporation. He received his MBA from Babson College and a BS in Business Administration from Northeastern University.

Associate Director, Finance and Administration

 

Kristen Gowen-MacDonald manages the daily business and operational functions of the company. She brings nearly 10 years of administrative experience, most recently in healthcare. Prior to Complexa, Kristen served as Office Manager and Executive Assistant at Merganser Biotech, Inc., where she supported the establishment of the company following its Series A raise and managed the opening of its corporate headquarters. Kristen received her BA in Spanish Language and Literature Anthropology from University of Colorado at Boulder. 

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