Clinical Pharmacology Scientist

Description

• Work as member of both Asian CPMS and global CPMS teams to develop and deliver Model Informed Drug Development Modelling and Simulation strategies to impact project strategy, decision making and accelerated approvals.
• Contribute to the design of an efficient clinical development program and a robust registration package for the Asia region and specifically Japan.
• Design the component of the Asia Phase 1 PK/PD strategy and associated study design elements within the assigned therapeutic area(s).
• Analyze and interpret clinical pharmacology studies, including those to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics.
• Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators.
• Innovate through working effectively with colleagues in the department and others such as statisticians, physicians, and regulatory affair staffs.
• Promote long term strategic initiatives in the development of innovative MID3 solutions to complex R&D problems.

Qualifications

• Clinical Pharmacology & MID3 Knowledge.
• 5-year or more experience in Clinical Pharmacology or Pharmacometrics area.
• Has developed a proficiency in scientific concepts associated with the practice and application of clinical pharmacology in terms of principles of pharmacokinetics and pharmacodynamics as this relates to R&D and therapeutics.
• Has developed a proficiency in clinical pharmacology in terms of understanding basic design principles, analysis, interpretation and reporting of Clinical PK and PK/PD studies including Phase 1 ethnic sensitivity studies.
• Has proficiency in the application of general clinical pharmacology and pharmacometrics skillset components associated with MID3 i.e. perform the analysis, interpretation and reporting of empirical and mechanistic population PK/PD
• Has gained proficiency in the deployment of MID3 within the context of decision making within a regulatory agency or pharmaceutical company.
• Has proficiency in development and implementation of regulatory strategies related to MID3 and or clinical pharmacology in general.