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

Positions

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.