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
Save Resume #1527
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)