The Clinical Pharmacology Scientist is responsible for developing and implementing the Clinical Pharmacology (CP) strategy in order to ensure that the right drug is administered to the right patient at the right dosing regimen. The CP Scientist uses state of the art model-informed drug development strategies that are aligned with project needs. The CP Scientist works on cross-functional teams in close partnership with Pharmacometricians, Biostatisticians, Clinicians, Biomarker Scientists, Toxicologists, Preclinical Pharmacologists, and other functions. Responsibilities include; leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols, analysis and interpretation of PK/PD data, preparation and review of regulatory documents, presentation of results at different forums (cross-functional teams, department meetings, governance meetings, conferences, etc.). Candidates will also represent Clinical Pharmacology in regulatory meetings (e.g. End of Phase 2, pre-BLA/NDA, etc.), and contribute to the planning, implementation and organization of regulatory filings (e.g. IND, BLA, NDA, sNDA). Performs other duties as assigned.
Familiarity with clinical study design options, especially for phase 1 and 2 studies. The ability to plan, organize, and interpret, assess and/or perform PK/PD data analyses is required. Working knowledge of statistical approaches as they apply to clinical study design & analysis. Working knowledge of relevant disease areas. Experience in interactions with regulatory agencies in highly desired. Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (e.g. NONMEM, WinNonlin, R, SimCYP, GastroPlus) is desired.
The CP Scientist requires excellent written communication skills, in order to deliver high quality protocols, publications, and regulatory documents for team and management review. Additionally, the CP Scientist must demonstrate excellent oral communication to make clear presentations to cross functional stakeholders and key decision makers. Strong leadership and interpersonal skills and the ability to influence are highly desired.
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, or cross functional project sub-teams. The CP scientist will be expected to represent CP on cross-functional project teams. Based on experience and ability, the CP Scientist may manage other Scientists or Scientific Researchers within CP department.
PhD, PharmD, MD, or equivalent
Strong track record of publications and external presentations is preferred
Multiple levels based on relevant experience in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
Senior Scientist 7-11 years of experience
Principal Scientist 12+ years of experience