Pharmaceutical Drug Development Consultant: Drug Modeling, Drug Portfolio Strategy and Regulatory Compliance
Technical Consultant #1527
- Pharmaceutical research and development methodology.
- Pharmaceutical research and development portfolio strategy and management.
- Drug development modeling, scenarios and matrices for decision support.
- Re-engineering and R&D core business systems; R&D budget and resource forecasting.
- Pharmacoeconomics, health outcomes and disease management.
- New Chemical Entities (NCE) drug development.
- Phase I to Phase IV drug pre-clinical and clinical safety assessments.
- Pharmaceutical IND, NDA and ANDA registrations.
- Submission Basis of Approval (SBA) summaries for registrations.
- FDA regulatory compliance; Pharmaceutical SOP and GLP.
- Toxicity study data interpretation, evaluation and reports and toxicity study protocols.
- Clinical pathology.
Zeneca Pharmaceuticals, (Formerly ICI Pharmaceuticals Group) Wilmington, DE, 1974 - 1997
- Manager, Health Outcomes, Medical Affairs, Stuart Disease Management Services
- Manager, Development and Planning
- Development Resource Associate, Drug Development
- Manager, Clinical Pathology, Biomedical Research & Development
- Research Biochemist, Biomedical Research & Development
- For drug portfolio, strategic and operational planning, project management, resource and financial direction, global development and re-engineering.
- Assessing methodology, developing planning processes and tools, data management, automating project management systems, and preparing health outcome studies in disease management.
- Developed and managed R&D budgets of up to $200 million for research management.
- Assessed drug development stages, strategic and operational planning methodology, implementation tactics using key factors driving or limiting the development of drugs in R&D. Helped reduced drug development cycle by 20%.
- Prioritized drug development candidates, developed scenarios for decision support and portfolio evaluation, and recommended drug portfolio decisions of $125 million.
- Ph.D. Biochemistry, Drexel University, Philadelphia, PA
- M. S. Chemistry, University of Mississippi, Oxford, MS
- M. S. Biochemistry, M.S. University, Baroda, India
- B. S. Chemistry, Kerala University, Kerala, India