Edward Paluch, Phd, Mba Email & Phone Number

Madison, NJ, US

New York, New York, US

• Led multidisciplinary teams for the development, conduct, management of pivotal Phase I through IV clinical trials and label comprehension/actual use studies in numerous therapeutic areas, and reporting of clinical.
• Drafted/filed clinical protocols, INDs, NDAs, sNDAs, and IND/NDA Safety Updates, and medical reports with FDA.
• Defined, implemented and managed domestic and international strategies and clinical development programs necessary for shifting prescription drugs from Rx to OTC status, and wrote/compiled briefing books and regulatory.
• Interacted with FDA regarding clinical development program/study design.

Chadds Ford, PA, US

• Led staff of 55 health care professionals (MD, PhD, and PharmD-level staff), with responsibility for the definition, management, and execution of key medical communication/publication plans, strategies, and product.
• Compiled and had oversight of annual compilation of 200+ peer-reviewed manuscripts/reviews and 1000+ abstracts and posters to support the execution of defined publication strategies/plans.
• Collaborated with pharmaceutical clients/potential clients (e.g., Amgen, Sanofi, Pfizer, Endo Pharmaceuticals, MedImmune, AstraZeneca) to maintain current clients, and explore new business opportunities.

Basel, Baselstadt, CH

• Designed/implemented global clinical research programs for drugs targeted for marketing as OTC products, in the cough/cold/respiratory, analgesic, and smoking cessation therapeutic categories.
• Designed Phase I-III clinical trials and strategic positioning of products, representing the clinical research function on Global Brand Teams.
• Managed advisory boards, and interacted with key thought leaders and regulatory agencies, regarding the safety and efficacy of the products.

Brentford, Middlesex, GB

• Managed staff of 20 safety scientists working on developmental stage compounds in the cardiovascular, metabolic, anti-infective, oncologic, and vaccine therapeutic areas.
• Evaluated and assessed safety data, evaluation of safety signals. Oversaw evolution of pharmacovigilance and risk management plans, drafting of the safety sections of investigator brochures, developmental core safety.

Brentford, Middlesex, GB

• Director, Product Safety Evaluation, Global Clinical Safety & PharmacovigilanceManaged a staff of 6 drug review specialists and all activities relating to global pharmacovigilance for all market-drugs in the GSK.
• Review of spontaneous adverse event safety data, identification of potential safety signals for all marketed drugs, and initiation of safety-related labeling revisions for US package inserts and global core texts.
• Conduct and supervision of drug reviews
• Supervision of preparation and submission of FDA Periodic Safety Reports and international Periodic Safety Update Reports for all marketed products.
• Represented the department in product liability litigation, presentations to FDA, and compiling responses to ad hoc safety inquiries from the FDA and foreign regulatory agencies
• Coordinated the preparation and dissemination of internal and external company statements pertaining to safety issues, and coordinated department-level activities with those of the Global Clinical.

Biomedical Sciences

Master Of Business Administration - Mba

Postdoctoral Fellowship In Clinical Immunology/Immunopathology

Bachelor Of Arts - Ba