<Principal Clinical Pharmacology Scientist>
【Job Purpose】
The CPMS Asia/Japan Manager will provide technical therapeutic, and product development support for GlaxoSmithKline projects. Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice of Modeling & Simulation (MS) and optimal application of Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds.
【Key Responsibilities】
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.
<Clinical Pharmacology Scientist>
As Clinical Development Professional you will be responsible for the execution and delivery of assigned studies across therapy areas to time, budget and quality as defined in the study protocol and local regulations. You will also serve as the local point of contact between the central study team and the in-country operational staff.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
・Accountable for the execution and delivery of assigned studies to timelines, budget and quality expectations
・Point of conduct for trial assessment or inspection
・Drive decisions related to the conduct of a clinical study locally including escalating issues
・Collaborate with global and local matrix teams on the local model informed consent form, local investigator meeting planning and oversight of training delivery, study performance and risk management, budget development and oversight of payments to sites and vendors
・Responsible for matrix leadership and project management
・Serve as the operational point-of-contact between the central study team and in-country operational staff
・Identify and share best practices while working to standardize across the local operating company and regions that may be involved in internal and external process improvement teams.
■休日:完全週休二日制, 年末年始