Associate Director, Quantitative Pharmacology, Clinical Pharmacology

Job Summary

Support all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Support study design, execution and reporting of clinical pharmacology and studies. Provide input into all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development. interact with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of clinical pharmacology submission documents and representative of the department at different product development team meetings. Participate in pharmacometrics and simulation and modeling plans and contribute to modeling and simulation activities. Interact with early development and business development team members and external collaborators to assess/lead development and selection of pre-IND and early phase assets.

Job Description

• Support clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
• Conduct PK and PK/PD analysis.
• Work with pharmacometrics team members and provide input related to analysis of PK and PK/PD.
• Author development of clinical pharmacology sections 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 assay development, sample management, pharmacogenomics and biomarker development.
• Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
• Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
• Mentor staff related to clinical pharmacology
• Serve as clinic****al pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects**.**

Qualifications/ Required

Knowledge/ Experience:

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry, Hands PK and PK/PD analysis and, Phoenix NLME.
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
• Great working knowledge of formulation development, drug development and clinical development.
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.

Skills

• Will apply scientific knowledge (in the areas specified above) to further our products, identify core problems, and apply analysis.
• Experience related to clinical pharmacology.

Educational Qualifications

• PhD, PharmD, MS in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 5 years of experience in these areas.
• Experience in population PK and PK/PD modeling and statistical models a plus.

#MS1

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Disclaimer: 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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