Study director for multiple Phase 2 and Phase 3 clinical studies.Leads a focused team of clinical development scientists for the development, initiation, and completion of Phase 2 through Phase 4 trials in the US and Globally.Provides key input on early development programs, including Phase 1 and non-clinical studies.Core Team Leader: Leads cross-functional study teams including Regulatory, Statistics, Operations, HEOR, Commercial, and Medical Affairs to ensure that all study and project objectives are met.Engages with and oversees external groups (ie, CROs, vendors) for studies in the US and ex-US.Interacts with regulatory authorities (ie, FDA, EMA, EU National Authorities) to discuss clinical study design and clinical data. Integral to the strategy, writing, and reviewing of regulatory documents in the US and Global, including lead speaker role at key regulatory meetings (eg, Ad Comm, EoPh2, pre-NDA, EU National Advice)

Leads a focused team of clinical development scientists for the development, initiation, and completion of Phase 2 through Phase 4 trials in the US and Globally.Provides key input on early development programs, including Phase 1 and non-clinical studies.Coordinates with Regulatory, Statistics, Operations, HEOR, Commercial, and Medical Affairs to ensure that all study and project objectives are met.Engages with and oversees external groups (ie, CROs, vendors) for studies in the US and ex-US.Interacts with regulatory authorities (ie, FDA, EMA, EU National Authorities) to discuss clinical study design and clinical data. Integral to the strategy, writing, and reviewing of regulatory documents in the US and Global, including attending and speaking at key regulatory meetings (eg, Ad Comm, EoPh2, pre-NDA, national advice).Presents study findings to Senior Management and external parties (eg, KOLs, FDA, EMA, Study Investigators, Partner Companies).Uses clinical and medical expertise to evaluate new potential drug products with Business Development throughout the Internal Medicine space: cardiovascular, respiratory, metabolic, urologic, renal, neurologic, and fibrotic disease states.Attends scientific meetings to keep up-to-date with current medical practice, as well as to meet with key opinion leaders and hold meetings for scientific/medical advice.Develops, authors, reviews, and finalizes study protocols, informed consents, investigator brochures, briefing books, and clinical study reports.Utilize scientific background and strategic thinking to leverage creativity through the sciences across multiple therapeutic areas, particularly in the cardiovascular and metabolic disease.Provides medical/scientific expertise to the internal teams for development of life-cycle strategies.

Internal Medicine (Cardiovascular, Respiratory, Metabolic)Utilizes technical and managerial experience to lead Phase 2 through Phase 4 trials (US and Global).Integral to the strategy, writing, and reviewing of regulatory documents (ie, NDAs) in the US and global.Develops and delivers presentations to internal (Senior Management) and external groups (KOLs, FDA, EMEA, Study Investigators, Partner Companies).Routinely coordinates with Regulatory, Statistics, Health Outcomes, Commercial, and Medical Affairs to ensure that all common objectives are met.Monitors and reviews clinical data for trends during the course of the study.

Cardiovascular/Metabolic and CNSContributes to core functions of product development including Data Disclosure and Nonclinical Study strategic planning for Viibryd and other compounds in Phase 2 through 4 of development.Works closely with the Product Development Team to prepare scientific materials needed for publication, commercialization, and other presentations of the drug program.Strong ability to communicate science and medicine to a broad audience, to provide strategic input to the drug development program, and to manage projects and tasks along the phases of drug development and commercialization.Leads investigator-initiated trials (IIT) strategy and process, projects generated by Commercial Team, as well as Development Team, and development and execution of non-clinical study strategy

Analyzed and developed medicinal proteins for Phase 3 clinical trials - Amevive (approved in 2003) and Tysabri (approved in 2004).Supported operational and technical aspects of clinical drug substance, drug product, reference standard, and placebo GMP stability programs.Provided technical expertise for the stability program of commercial and clinical products.

Developed and implemented methods for preparing mammalian cell cultures for protein purification.Supported cell biology efforts including maintenance of cell lines and cell imaging.In-depth training in FDA standards and guidelines (GLP and GMP), plus exposure to routine FDA audits.