Occupation:Clinical Research |
Location:Evanston, IL |
Education Level:Medical Degree |
Will Relocate:YES |
Description
QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience (~ 120 clinical trials) in clinical development (mainly Phase I to III) with focus on clinical programs and life cycle integrated strategy including Preclinical, CMC, Regulatory, Clinical, Medical Affairs and Marketing in a variety of therapeutic areas such as Pain/Inflammation, Oncology, CV/Metabolism, Respiratory, and Neurology. * VP or Sr Project Leader/Director roles in charge of Clinical Program Strategies and Product Life Cycle within Matrix environments or direct reporting of functions. * Multiple and successful interactions with the FDA, European, and LatinAmerican Regulatory agencies. Comprehensive understanding and implementation of FDA/EMA Regulations and FDA/ICH Guidances. * Participated in 5 NDAs: Naproxen OTC, Tagamet Complete, Keppra, Simcor ( simvastatin + niacin), and Paxoral (oral paclitaxel). * Preparation, submission and direct responsibility of 5 IND and 3 CTA submissions. * Broad Medical Affairs experience and medical advisor in license and acquisitions in the last four companies (including AbbVie) resulting in the successful acquisition of 4 products. * Author of multiple clinical strategies/programs/protocols, clinical & statistical study reports, regulatory documents (IBs, NDAs), SOPs, and innumerable safety reports and risk management documents. Proficient in applied biostatistics to clinical development. * Safety Officer and Director of Global Pharmacovigilance activities across companies for 9 years. * Robust understanding of CMC/formulation, PK/PD, toxicology, MoA pharmacology, biostatistics & translational medicine. * US Citizen. Born in Barcelona Spain. PHARMACEUTICAL EXPERIENCE
Accomplishments
Highlights:
Keywords
