Associate Director, Quantitative Pharmacology, Pharmacometrics

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. 

This position can be based in Princeton, New Jersey, or Rockville, Maryland. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options may be considered within the US.

As an Associate Director, Quantitative Pharmacology, Pharmacometrics, you will support all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis, execution and reporting of pharmacometrics studies, while providing input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. You will Author clinical pharmacology and pharmacometrics submission documents and represent the department at different product development team meetings. This individual will conduct pharmacometrics and simulation and modeling activities to provide input on modeling and simulation activities. In this role, you will interact 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.

Job Description

• Conduct pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data.
• Conduct Physiologically-Based Pharmacokinetic (PBPK) modeling, population PK, PK/PD and modeling and simulation.
• Provide pharmacometrics analysis and participates in activities related to analysis and reporting of translational PK, population PK and PK/PD analyses.
• Author pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans.
• Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK, PBPK and PK/PD.
• Work with formulation development groups and provide support for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
• Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
• Interact with clinical pharmacology to support PBPK, population PK and PK/PD modeling
• Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and supports model-based drug development strategies for ongoing projects.

Qualifications/ Required

Knowledge, Experience, and Competencies:

• In-depth knowledge of pharmacometrics, PBPK, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands PK and PK/PD analysis and statistical analysis using SimCYP, NonMEM, Phoenix NLME, Julia, R, etc.
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements.  
• Good working knowledge of formulation development, drug development and clinical development.
• Current awareness of the latest developments in clinical pharmacology and guidance documents.

 
Skills:

• Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong technical and hands on experience related to pharmacometrics, population PK and PK/PD modeling.
• Strong organization skills.
• Strong communication skills.
• Flexibility to react rapidly to changing situations/environment.

Educational Qualifications:

• PhD in pha