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Pharmaceutical Drug Development Consultant: Drug Modeling, Drug Portfolio Strategy and Regulatory Compliance

Technical Consultant #1527


Expertise

  • 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.

Experience

Zeneca Pharmaceuticals, (Formerly ICI Pharmaceuticals Group) Wilmington, DE, 1974 - 1997

Positions

  • 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

Responsibilities

  • 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.

Education

  • 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
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