Senior clinical leader responsible for developing clinical strategies and oversight of various aspects of a large global cardiovascular clinical development program.

Associate Director, Clinical Scientist, Cardiovascular Therapeutic Area (Rivaroxaban)Responsible for CRO and ARO (Academic Research Organization) oversight for a large Cardiovascular outcomes trial. Key responsibilities include management of study Clinical Events Committee, National Lead Investigators and other global key opinion leaders.

Associate Director, Clinical Development for Ethicon Biosurgery (Johnson & Johnson). Responsible for clinical development activities within Ethicon Biosurgery including resourcing, budgeting, people management and vendor management.Lead the development of clinical strategies for novel surgical solutions (device, biologic and combination products).Represent clinical development on numerous new product development teams and health authority meetings.

Manager of Clinical Development for Ethicon Biosurgery (Johnson & Johnson). Manage a group of clinical development professionals and CROs in the execution of Phase II, Phase III and Phase IV (post-market and pediatric commitments) clinical trials of Biologic and Combination Products in the Gastroenterology, Cardiovascular and General Surgery therapeutic areas. Develop clinical strategies and clinical study plans including, protocols, resources, budgets and timelines for Biologic, Devices and Combination (Biologic & Device) products. Work closely with cross functional partners to support drug approval, launches and compliance including but not limited to, supporting data management, drug safety, regulatory submissions (i.e. IND, BLA) and Pharmacovigilance (RMPs, safety reporting).

Lead the clinical development of new medical devices and in vitro diagnostics, including, the management of feasibility, safety & efficacy and post market studies.Manage and mentor Clinical Project Leaders. Participate in Business Development and Strategic Planning activities.

Led interdisciplinary teams to perform clinical feasibility research and market research on medical devices.Participated in the creation and validation of new product business plans. Implemented best practice clinical project management tools and methods to the clinical project management department.

Led an interdisciplinary team to the successful completion of a Multi-Center, Medical Device, Randomized, Safety & Efficacy clinical trial contributing to a successful launch of a new product. Managed the execution of a Pilot Class III Medical Device trial. Supported submissions of Pre-Investigational Device Exemption (IDE), IDE and 510k applications to the FDA. Managed numerous clinical trial teams:Study management responsibilities included: authoring protocols, leading cross-functional teams, managing budgets and timelines, managing Clinical Research Organizations and other vendors and interacting with study sites.

Provided regulatory submission, advisory board and litigation support for various clients through literature reviews and subject matter expert consultations.