Job Description

• Conduct pharmacometrics activities related to pre-IND, IND, phase1-3, regulatory meetings and regulatory submissions.
• Provide pharmacometrics analysis and participates in activities related to analysis and reporting of pharmacometrics analyses.
• Author pharmacometrics sections of clinical pharmacology documents for regulatory filings including investigator's brochure, IND/NDA/BLA applications, pediatrics development plans, and etc.
• Manage pharmacometrics activities related to project budgets, outsourcing of pharmacometrics analyses, contract requisition, and SOW.
• Serve as pharmacometrics lead on project teams and interact with cross-functional teams including clinical pharmacology, clinical development, safety, biostatistics, regulatory and etc. to support model-based drug development strategies for all phases of drug development programs.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Strong technical and hands on experience in pharmacometrics modeling.
• In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, R etc,
• Excellent working knowledge of phase I-III clinical trials, 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 pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with 4+ years of experience in these areas.
  

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.

Equal Opportunity Employer

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.

#LI Hybrid

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

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