|Senior Director, Quantitative Pharmacology|
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 07/22/2021
Expire Date: 08/22/2021
Job Categories: Medical
Senior Director, Quantitative Pharmacology |
Job Summary: This position can be located in Princeton, NJ; Rockville, MD, OR Waltham, MA.
The Senior Director, Quantitative Pharmacology oversees all pharmacometrics and PK/PD activities within the Early Phase and Translational Medicine (EPTM) group from IND to NDA for small molecules as well as biologics. Works with VP of EPTM to align of modeling and simulation activities and priorities within EPTM and cross functional groups. Works with therapeutic areas leads to set Model Informed Drug Development (MIDD) strategies for ongoing programs and oversees execution of the analyses within the EPTM or external vendors.
Oversees, mentors and provide technical expertise for population PK and PK/PD modeling activities of direct reports as well as other EPTM team members. Provides model-based input related to dose finding, dose optimization, exposure-response, and pediatric development. Reviewer and/or approver of pharmacometrics reports as well as clinical pharmacology submission documents. Serve as development lead/co-lead of biologics with partner company with respec t to PK, PK/PD, FIH dose decision and POC studies.
Works closely with EPTM team members on activities related to clinical pharmacology for small molecules as well as biologics. Closely interacts with non-clinical and bioanalytical team members to introduce model-based approaches for first-in-human, biomarker, genomics as well as digital.
Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.
* Recognized expertise in modeling and simulation approaches (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, data set creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
* In-depth modeling skills, ability to translate complex problems into incisive models.
* Deep knowledge of model-based drug development approaches, pharmacokinetics and pharmacology and basic science skills required.
* Proven leadership skills managing complex technical and scientific team members and proven track record of leading pharmacometrics teams.
* Strong technical communication skills and proven track record of interacting with senior management and health authorities at global level.
* In depth knowledge of Clinical Pharmacology and pharmacometrics regulations and technical knowledge of drug development regulations.
* In depth, technical and hands on pharmacometrics, PK/PD and statistical analysis experience using NonMEM, R, Phoenix NLME etc.
Education and Related Experience
* PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area with a minimum of 15 years of experience in these areas.
* In depth, technical expertise in population PK and PK/PD modeling and statistical models.
* Technical experience in drug development for both small molecule and biologics.