Specialist Clinical Pharmacology

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

· 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