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:
Job Duties in general include but are not limited to the following:
· Work independently or with minor guidance to support ongoing projects.
· Independently perform PK/PD analyses.
o Non-compartment PK/PD analysis
o 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:
No supervisory responsibilities.
Job Requirements:
- 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
