Principal Clinical Pharmacologist (SA I), Clinical Pharmacology Group

Major Responsibilities：

• Responsibility/co-responsibility for the Clinical Pharmacology programme for allocated projects including:
• Contribute to develop the Clinical Pharmacology part in Clinical Plan
• Contribute to plan and conduct Clinical Pharmacology study(ies) to assure global data bridging and East Asia’s participation to global P2 and/or P3 trials
• Representative of Clinical Pharmacology in Clinical Sub Team/Clinical Study Team
• Close collaboration with Research, Non-clinical and Therapeutic Areas and other functions
• Provide Clinical Pharmacology expertise to the assigned Clinical Study Team
• Assess clinical data to evaluate whether or not ethnic difference exists regarding PK as well as PK vs efficacy / safety relationship
• Responsibility/co-responsibility for Clinical Pharmacology parts of main documents including investigator’s Brochures, Protocols, Clinical Study Reports and all submission relevant documents
• Assessment of the scientific/medical quality of external Clinical Pharmacology Units in close corporation with Global Exploratory Development and Outsourcing & Contracting
• Represents/co-represents Clinical Pharmacology for market approval submission to regulatory authorities, authority meetings and answers to all related authority questions
• Input to licensing projects on demand of Business Development or others as well as active scouting for potential relevant projects for in-licensing
• Cooperation with Commercial functions including publications, presentations, conference participation
• Responsibility for assigned Clinical Pharmacology trials including communication with the investigator review of the trial and the ethical content of all major documents (protocol, CSR)
• Establish the network with external specialists ( PK & Clinical Pharmacology field )
• Establish the network with Global UCB counterparts
• Coach junior staff on strategic/technical issues
• Contribute functional activities

Requirement：

• Knowledge for clinical development, clinical trials, GCP, related regulations and NDA
• At least 7 years within the pharmaceutical industry experience or equivalent, including considerable experiences in clinical pharmacology
• Knowledge of clinical pharmacology, including the design and conduct clinical trials, interpretation of population pharmacokinetics and PK/PD modelling/simulation data as well as the use of biomarkers in early clinical development
• Preferable to know Population pharmacokinetics, Pharmacogenomics, PK/PD modeling, Biostatistics
• Understand cross-cultural issues
• English capability