Job Title: CPMS Asia/Japan Lead

The CPMS Asia/Japan Lead will provide technical therapeutic, and product development support for GlaxoSmithKline projects.

About the Role:

• Ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds.
• 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.
• Support long term strategic initiatives in the development of innovative MID3 solutions to complex R&D problems.

About You:

• 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 gained 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 an understanding of how to develop and implemented regulatory strategies related to MID3 and/or clinical pharmacology in general.

Requirements:

• Graduate degree of medical, pharmaceutical, life science or taken enough training for clinical field.
• English reading comprehension, writing skills for English documents, and excellent communication skills in English that enable deep discussion with global relevant members.
• Relevant experience in clinical pharmacokinetics/modelling and simulation/drug development.
• Relevant Clinical pharmacology experience.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.

Estimated Salary: $120,000 - $180,000 per year