Assoc. Dir./Director, Clinical Pharmacometrics
This individual will be responsible for all internal and external clinical PK and PK/PD modeling and simulation activities. The primary initial responsibility will be to oversee the design, conduct, and reporting of modeling and simulation analyses conducted by external CROs in support of product registration of a small molecule therapeutic. Responsibilities will also include conduct of PK/PD analyses of data from Phase 1/2 studies of small molecule development compounds and application of quantitative decision-making to assist in the elucidation of dose- and exposure-response relationships to optimize subsequent clinical development. In addition, the applicant will contribute to the PK analysis, interpretation and reporting of PK results from clinical trials, and, based on prior experience, the candidate may serve as the primary Clinical Pharmacology representative on select Project teams and/or liaise with Nonclinical colleagues to assist in PK/PD modeling of discovery and development compounds in nonclinical test systems. This individual will also be expected to develop and implement a long-term Modeling and Simulation strategy for the organization.
- Must possess a Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation.
- Significant industry experience (Assoc. Director: Ph.D. with 8+ years of experience, MS with 10+ years or experience; Director: 10-15 years for Ph.D., 15+ years for MS) in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses
- Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
- Demonstrated ability to independently design studies to characterize PK/PD relationships of clinical development compounds
- Experience in working in a cross functional team and matrix environment
- Competent in the use of PK and PK/PD Modeling software tools including WinNonlin, NONMEM, S-Plus and SAS
- Strong written, presentation and verbal communication skills
- Prior experience preparing NDA/MAA summaries of population pharmacokinetic PK/PD analyses would be highly beneficial