Essential Functions of the Job (Key responsibilities)
- Contribute to Clinical PK & Clinical Pharmacology plans in collaboration with CPP leads and project teams.
- Execute the pharmacometric analyses, such as PKPD, PPK, exposure-response, tumor growth dynamic modeling, or PBPK analyses, and interpret the results to recommend dosing paradigm for different phases of clinical development; contribute to the justification for dose selection for pivotal clinical trials.
- Liaise with CPP leads, Clinical Biomarker leads, and preclinical scientists to come up with fit-for-purpose models pertinent to the clinical development; collaborate with BioStats, Data Management, Clinical Operations & Medical and have an impact on development projects
- Generate reports for PK/PD analyses, population PK, exposure-response analyses, clinical trial simulations, comparator modeling, or PBPK analyses.
- Have a general understanding of global regulatory guidance on various pharamcometrics analyses and reporting.
- Present data and recommendations to project teams, external collaborators and senior management.
- Publish in peer reviewed journals.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D. in an appropriate discipline that lays the foundation for the job functions detailed above; strong background in mathematics/statistics and a deep understanding of molecular pharmacology.
- Hands on experience with NONMEM, R, Phoenix, Monolix, SimCYP, GastroPlus, Matlab, or other programs
- Hands on experience with PK/PD, pop PK, ER, or PBPK.
- 7-10 years or more of related industry and/or FDA experience.
- Experience working in a matrix environment.
- Appropriate publication record is required.
