Collegeville, Pennsylvania, United States
I bring over 25 years of experience in the pharmaceutical and biotech industries, currently serving as a Director in Clinical Science within the Gastroenterology and Inflammation Therapeutic Area Unit at Takeda Pharmaceutical Company. My career spans multiple therapeutic areas across immunology, inflammation, gastroenterology, nephrology, neuroscience, and specialty biologics, with experience advancing complex assets from early development through Phase III and lifecycle planning.Throughout my career, I have held roles of increasing responsibility at leading pharmaceutical organizations including Bristol-Myers Squibb, Wyeth, Johnson & Johnson (Centocor/Janssen), Pfizer, Shire Pharmaceuticals, and Takeda. I have worked across diverse biologic and small molecule platforms, contributing to clinical development strategy, regulatory alignment, and cross-functional franchise integration in highly competitive and rapidly evolving markets. A consistent theme across my career has been scientific partnership and Key Opinion Leader (KOL) engagement. I have led national and regional KOL mapping initiatives across multiple disease states, designed and executed advisory boards and steering committees, and partnered directly with leading academic and community experts to refine development strategy, endpoint selection, and positioning considerations. I routinely synthesize external scientific insights into actionable recommendations that inform governance discussions, portfolio prioritization, brand planning, and launch readiness efforts. In addition to therapeutic leadership, my expertise encompasses enterprise transformation, portfolio strategy, business development, project management, and risk management. I have represented R&D in executive governance and investment forums, supported major partnership evaluations, and helped align Medical Affairs, Marketing, Commercial, and Market Access stakeholders around data-driven strategic priorities. I have also spent 11 years as a successful independent advisor supporting large, mid-sized, and emerging biotech and medical device companies, strengthening my ability to operate across complex organizations and build trusted executive and scientific relationships. Beyond industry leadership, I have contributed to academia as a part-time adjunct professor at Temple University’s College of Pharmacy and Drexel University’s College of Medicine, teaching graduate-level courses in pharmaceutical development, GCPs, ethics, enterprise risk management, the business of biotech, and leadership in life sciences.
- Lead strategic KOL and Emerging Thought Leader engagement, translating external scientific relationships into insights that shape clinical development strategy, study design, and disease-area positioning. - Build partnerships with medical associations, nonprofit foundations, and external consortia to advance strategic initiatives and strengthen disease-area readiness for clinical trials and scientific engagement. - Drive Clinical Science representation for congress and medical meeting strategy, including end-to-end planning, KOL/PI engagement, competitive intelligence capture, and insight-driven action planning. - Partner with Medical Affairs, Commercial Strategy, and Launch teams to support Target Product Profile and Commercial Strategy Plan development, external stakeholder alignment, and integrated scientific communications across development and pre-launch planning. - Lead a scalable disease-centric network model to improve trial execution, launch readiness, and long-term marketplace performance across therapeutic areas. - Oversee execution of leadership recommendations, while advancing recruitment acceleration strategies that have delivered enrollment materially ahead of projections in a highly competitive indication.
- Interact with internal and external partners such as Clinical Operations, Clinical Pharmacology, Regulatory, Commercial, Compliance, CRO and vendor teams, leveraging scientific expertise and providing guidance in support of successful product development programs. - Responsible for leading large, international clinical trials by providing oversight of study execution, clinical trial medical monitoring, day-to-day clinical activities, as well as ongoing data review to ensure all regulatory authority requirements, stakeholder requirements, and quality standards are met and all leading to final study report authoring, review, and approval. - Participate in search and evaluation projects to identify strategic investment opportunities to expand the R&D portfolio.
- Engaged to assist large, medium, small, and start-up pharmaceutical, biotech, and medical device companies in successfully planning, designing, conducting, analyzing, and reporting their clinical research efforts and associated tasks; - Engagement roles includes clinical scientist, site manager, project manager, local trial manger, global trial manager, medical writer, auditor, and site rescue; - Engaged in over 75 pharmaceutical and medical device research studies; - Extensive experience in over 13 different therapeutic areas; - Clients include Pfizer, Johnson & Johnson (Centocor, Tibotec, Janssen and J&J PRD), Shire Human Genetics, Eli Lilly, Neurotez, Esperion Therapeutics, X4 Pharma, IntraBio, AshaiKASEI, Smith & Nephew Orthopedic Devices, and DePuy Medical Devices. Broad therapeutic area experience, including: - Cardiology/Vascular Diseases - Dermatology - Endocrinology - Gastroenterology - Hematology - Immunology/Infectious Diseases - Musculoskeletal - Nephrology - Psychiatry/Psychology - Pulmonary/Respiratory Diseases - Rheumatology Extensive experience in: - Pediatrics/neonatology studies - Clinical Pharmacology studies - Japanese Bridging studies
- Focused on the successful early development of novel biopharmaceuticals. - Study Team Leader for several high profile clinical pharmacology studies to support an impending GI BLA submission.