Substantial career in academic medical practice. 10+ years in Pharma industry specializing in clinical development and medical affairs. Looking for opportunities to pursue development of new and innovative treatments of cardiovascular disease.
President @ From September 2013 to Present (2 years 4 months) Greater New York City AreaVP for Clinical Development-CV @ Clinical development of allogeneic mesenchymal precurser cells in cardiovascular indications. From February 2011 to August 2013 (2 years 7 months) New York, NYTherapy Director @ Recruited to create, implement, and manage clinical strategic plans as member of Senior Leadership Team (SLT). Oversee Phase I-IV clinical studies and investigator-initiated trials to support clinical and scientific strategy for multiple therapeutics. Develop and review study protocols, case report forms, and serious adverse events; evaluate preclinical data for new devices and therapies. Monitor and allocate investigator educational grants. Support marketing and sales efforts, as well as scientific education, thought leader mapping, speakers' bureau selection, and KOL development.
Notable successes:
Selected as member of AD/Prom review team for Cellular Therapies products and materials; appointed as member of SOP review/development team and supported Medical Affairs Integration Project.
Provide comprehensive review assistance to global pharmacovigilance team on licensed products. From June 2008 to August 2010 (2 years 3 months) Medical Director, Cellular Therapies @ Oversaw all clinical trial activities associated with autologous stem cell therapy for acquired heart and vascular disease. Supervised all medical affaires activity associated with cell therapies including KOL identification, Advisory Boards, and management training. Was subject matter expert supporting Quality, Regulatory and Commercial groups involved in cell therapy and regenerative medicine activities. From April 2007 to August 2010 (3 years 5 months) DIRECTOR @ Directed and sported all medical affairs activity for Baxter'S Biosurgery division including KOL development and management, Investigator Initiated Trials, Salesforce training, AdProm review, presentations Was subject matter expert for Quality, Global Regulatory, Compliance and R&D. From April 2007 to June 2008 (1 year 3 months) Senior Medical Director @ Supervised and directed all clinical development activities within the cardiovascular therapeutic area clinical development. Directed all medical affairs activities including KOL development, Advisory Board presentations, MSL training, Commercial support, Phase IV trial management. From January 2003 to March 2007 (4 years 3 months) Senior Medical Director @ Global biopharmaceutical company specializing in development of therapeutics to treat severe, life-threatening, and rare diseases; Oversee clinical development of compounds from pre-clinical activities through NDA and post-approval efforts. Designed Phase I-IV clinical trials; analyzed and presented results and interacted with internal units, including commercial development, clinical operations, and regulatory affairs.
Notable successes:
Established protocols and conducted Phase II-III clinical trials with investigational compound (monoclonal antibody fragment) to determine applications in acute coronary syndromes. Skillfully executed and monitored placebo-controlled, randomized trials with approximately 15,000 enrolled patients in 25 countries; studies resulted in several publications.
Organized/conducted Phase I through III clinical trials in use of monoclonal antibody to inhibit complement in anti-inflammatory indications, transplantation, asthma, and malignant hematology.
Appointed as protocol physician and medical monitor for two Phase III trials in CABG surgery; tracked multi-site, global, double-blind trials involving 7,300 patients.
Served as physician and medical monitor for Phase III trial in acute myocardial infarction with estimated enrollment of 8,500 patients. Compared techniques of myocardial preservation/protection during open-heart surgery. As result, potassium blood cardiophegia was adopted as primary technique of myocardial protection during cardio-pulmonary bypass. From January 2003 to March 2007 (4 years 3 months) PRIVATE PRACTICE @ pediatric and adult cardiac and thoracic surgery. From January 2000 to January 2002 (2 years 1 month) Associate Director @ Was director of the Thoracic surgery section responsible for all activities and training o surgicalf residents. From January 1998 to January 2000 (2 years 1 month) Deputy Director of Surgery @ Responsible for all activities of the department in association with the Director of Surgery. From January 1996 to January 2000 (4 years 1 month) Associate Professor of Surgery @ Responsible for training residents in surgery and overall supervision of heir academic experience. From January 1983 to January 2000 (17 years 1 month) PRIVATE PRACTICE @ From January 1981 to January 1996 (15 years 1 month) Associate Director @ From January 1976 to January 1981 (5 years 1 month)
Doctor, Medicine @ New York University From 1965 to 1969 MD, Medicine @ New York University School of Medicine From 1965 to 1969 Bachelor of Arts (BA), Political Science and Government @ Georgetown University From 1961 to 1965 Peter MD is skilled in: Clinical Trials, Clinical Research, Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Cardiology, Medical Devices, Protocol, Infectious Diseases, Hematology, Biopharmaceuticals, Oncology, Pharmaceutical Industry, Medicine