Senior project director managing a consortium comprised of pharmaceutical companies, academic researchers and government agencies (NHLBI), supported by the COPD Foundation. Goal is to qualify biomarkers for COPD (chronic obstructive pulmonary disease) by integrating and analyzing data from multiple sources, and submitting dossiers to the FDA and/or publishing the results. Activities include managing vendor relationships, program management (scope, schedule, resources), Steering Committee… Show more Senior project director managing a consortium comprised of pharmaceutical companies, academic researchers and government agencies (NHLBI), supported by the COPD Foundation. Goal is to qualify biomarkers for COPD (chronic obstructive pulmonary disease) by integrating and analyzing data from multiple sources, and submitting dossiers to the FDA and/or publishing the results. Activities include managing vendor relationships, program management (scope, schedule, resources), Steering Committee support, working group integration. Show less

Senior leader for Corporate Project implementation and Research and Development Benchmarking

Divisional implementation lead for COMET program, a business process re-engineering project implementing standard practices for Order to Cash, Supply Chain Management, Financial Business Management, Source to Settle and HR. Include development and deployment of SAP on a global basis.

Designed and established PMO (Program Management Office). Hired 13 people into the group and served as department head. Capabilities included internal metrics development and external benchmarking, External competititve intelligence (research), project management standardization and best practices, project management for governance committees, Development Team and Project Management training

Increasing responsibility in the research PM group.Exec Director: 2001-2005Sr Director: 1999-2001Director: 1996-1999Coordinator / Sr Project Manager: 1992-1996Led group of >50 PM and resource professionals, setting dept. direction, assigning resources for all phases of drug development , and executing change and continuous improvement projects. --Governance Committees: Managed multiple divisional executive portfolio committees - all stages of product… Show more Increasing responsibility in the research PM group.Exec Director: 2001-2005Sr Director: 1999-2001Director: 1996-1999Coordinator / Sr Project Manager: 1992-1996Led group of >50 PM and resource professionals, setting dept. direction, assigning resources for all phases of drug development , and executing change and continuous improvement projects. --Governance Committees: Managed multiple divisional executive portfolio committees - all stages of product development--Portfolio integration: supported divisional President in preparation of strategy/portfolio data & presentations to shareholders & securities analysts--Project Team Co-Leader: COZAAR/HYZAAR (hypertension), CRIXIVAN and STOCRIN/SUSTIVA (AIDS). Led all 3 teams from first in man through successful commercialization. COZAAR/HYZAAR now a multi-billion dollar franchise.--Proj Mgr: for multiple drug & vaccine development projects (cardiovascular, neuroscience, infectious disease, vaccines). Show less

Held positions of increasing responsibility in Clinical Research, focusing on cardiovascular and OTC drug development. Managed several successfully launched compounds through all phases of development. -- **protocol design and authoring, **clinical site selection and monitoring, **management of clinical investigator meetings and **preparation of study summaries.--Authored sections of worldwide regulatory applications, including summaries of efficacy and safety--Developed… Show more Held positions of increasing responsibility in Clinical Research, focusing on cardiovascular and OTC drug development. Managed several successfully launched compounds through all phases of development. -- **protocol design and authoring, **clinical site selection and monitoring, **management of clinical investigator meetings and **preparation of study summaries.--Authored sections of worldwide regulatory applications, including summaries of efficacy and safety--Developed presentations for regulatory Advisory Committee meetings--Designed and maintained databases for several important safety issues. Co-authored summary manuscript related to ACE inhibitors and angioedema - published in JAMA. Show less

--Managed Compassionate Use program (>3,000 patients with life-threatening ventricular arrhythmias) for anti-arrhythmic compound. Prepared summary report for inclusion in NDA.--Coordinated clinical program for investigational antidepressant agent. Responsibilities included protocol design and operational execution, on-site data monitoring/quality assurance and study report preparation.

Conducted and analyzed in vitro and in vivo experiments in animal models to assess antiarrhythmic activity of experimental compounds (Langendorf rabbit heart preparation, mouse fibrillation model, Harris ligated dog model)