Oversees all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology studies. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author/reviewer of clinical pharmacology submission documents and representative of the department at different product development team meetings. Works closely with pharmacometrics and simulation and modeling team members to provide input on modeling and simulation activities. 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.
- Lead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
- Conduct PK and PK/PD analysis.
- Work closely with pharmacometrics team members and participate in activities related to analysis and reporting of PK and PK/PD analyses.
- Lead 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.
- Training and mentoring of staff.
- Serve as clinical pharmacology team member on multiple project teams and as a team member on other key projects as needed.
Education and Related Experience
- PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area with a minimum of 10 years of experience in these areas.
- Experience in population PK and PK/PD modeling considered.
Knowledge, Skills, and Competencies
- In-depth knowledge of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
- Good working knowledge of formulation development, drug development and clinical development.
- Current awareness of the latest developments in clinical pharmacology and guidance documents.
- 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 organization skills.
- Strong communication skills.
- Flexibility to react rapidly to changing situations/environment
Travel 20% 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.Statement Regarding Job Recruiting Fraud Scams
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