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Job Description:
Job Overview:
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
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
