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.

Technical Skills:

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.

Communication Skills:

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.

Leadership:

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.

Qualifications:

• 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

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