Senior Specialist Clinical Pharmacology

The Senior Specialist Clinical Pharmacology (SSCP) is responsible for study design, data analysis including population pharmacokinetic/pharmacodynamic (PopPK/PD) analyses, and result interpretation of clinical trials. Responsibilities also include preparation of data analysis plan including PopPK/PD analysis plan, TLF (Table, Listing, Figure) design, and result report.

Job Duties and Responsibilities

• Work independently or with minor guidance to support ongoing projects.
• Independently perform PK/PD analyses.
• Non-compartment PK/PD analysis
• Compartment PK/PD analysis, modeling and simulation
• Review and QC analysis results and outputs for other team members.
• Ensure working process following good practice of study requirement and SOPs.
• Participate in group meetings and ongoing project team meetings including meeting slide preparation for study updates and identified issues.
• Be exposed to other functions within Clinical Sciences.
• May involve in junior member training, coaching, and mentoring.

Supervisory Responsibilities

Nosupervisory responsibilities.

• Education
• Master degree in pharmacokinetics, pharmaceutical sciences, or related discipline; Ph.D. or Pharm.D. will be a plus

• Experience
• Generally, 3 or more years hands-on experience in PK / PD analysis, or clinical pharmacology or related experience
• Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines
• Knowledge of model-based drug develop principles and ability to apply related tools
• Proven track record in preparing clinical pharmacology related study design and analysis with minimum supervision

• Skills/Competencies

• Solid knowledge of pharmacokinetic principle and drug development process
• Must be proficient with at least one PK analysis software such as Phoenix WinNonlin, NONMEM etc.
• Ability to interpret analysis results and impact on the study medication
• Must be detail-oriented, highly organized, and able to manage multiple tasks
• Must have critical thinking and problem-solving ability
• Strong motivation and problem-solving abilities are required
• Knowledge in relevant Therapeutic Areas to enhance contributions to a project
• Familiar with ICH/GCP guidelines, and FDA, EMA, and CDE guidance
• Proficient in spoken and written English
• Capabilities
• In addition to Phoenix WinNonlin and NONMEM, knowledge and application of a broad range of CP tools including but not limited to, SAS, R and other related software
• Ability to work remotely
• Ability to work within a team
• Ability to work in a cross-function environment
• Ability to travel, if needed