The Clinical Pharmacology Scientist/Senior Scientist (CP Scientist) is responsible for the Clinical Pharmacology (CP) strategy for his/her development project[s] in order to ensure that appropriate dose/route/schedule decisions are made for the patients. The CP Scientist uses state of the art model-informed drug development strategies that are aligned with project needs. The CP Scientist works in close partnership with Pharmacometricians, Biostatisticians, Clinicians and cross-functional project teams. Responsibilities include; leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols and analysis plans, analysis and interpretation of PK/PD data, preparation and review of clinical study reports, presentation of PK/PD data at cross-functional teams, department meetings, conferences and regulatory meetings as well as planning, implementation and organization of regulatory filings (eg. IND, End-of Phase 2 meeting, EU Scientific Advice meeting, BLA, NDA, sNDA). Performs other duties as assigned.
Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses. Familiarity with clinical study design options, especially for phase 1 and 2 studies. Working knowledge of statistical approaches as they apply to clinical study design & analysis. Working knowledge of relevant disease areas.
The CP Scientist requires excellent communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.
Drug Development Knowledge:
The CP Scientist requires relevant experience/knowledge of how CP science can impact drug development. CP Scientist should have a good knowledge of GCP and working knowledge of relevant regulatory guidelines.
Based on experience and ability, the CP Scientist may lead CP teams, project sub-teams and represent CP at cross-functional project teams. Based on experience and ability, the CP Scientist may manage other Scientists or Research Associates within CP department.
- MD, PhD, PharmD or equivalent
- Multiple levels based on relevant experience in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
- Scientist 0-3 years of experience
- Senior Scientist 3-5 years of experience