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General Description:

We are seeking a highly motivated candidate to join our Clinical Pharmacology and Pharmacometrics (CPP) group. The successful candidate will support a variety of Clinical Pharmacology activities, including tasks related to non-compartmental analysis (NCA), data visualization, table generation, quality control (QC) of results, and data curation to support novel small molecules and biologics assets in the company portfolio. This role requires a strong STEM background and proficiency in data manipulation tools such as R and/or Phoenix WinNonlin (WNL). Exposure to clinical pharmacology and pharmacometric approaches for characterizing pharmacokinetic profiles; assessing drug/food interaction potential; characterizing QT prolongation potential, etc is desirable but not required.

Essential Functions of the Job:

You will work with experienced colleagues in the CPP group on facilitating the following activities to support Exploratory Analyses, CSRs, Health Authority responses, or Marketing authorization/NDA/BLA submissions:

+ Non-Compartmental Analysis (NCA):

+ Perform NCA to characterize the pharmacokinetics of drug candidates.

+ Interpret and report NCA results.

+ Data Visualization and Table Generation:

+ Create visualizations and tables to effectively communicate pharmacokinetic and pharmacodynamic data.

+ Ensure accuracy and clarity in data presentation.

+ Quality Control (QC) of Results:

+ Perform QC checks on analysis results to ensure data integrity and compliance with internal and regulatory standards.

+ Document QC processes and findings.

+ Data Curation and Engineering:

+ Modify large datasets to prepare for analysis.

+ Utilize tools such as R and Phoenix WNL to streamline workflows.

+ Support assembly of relevant ClinPharm datasets.

Supervisory Responsibilities:

+ Assist with and/or lead internal trainings periodically

Computer Skills:

+ Proficiency in using R for data manipulation, visualization, and basic statistical analyses is required.

+ Hands-on experience in performing NCA using Phoenix WinNonlin is preferred.

+ Experience or exposure with one or more of the following is desirable: NONMEM, Berkeley Madonna, Simcyp, Gastroplus, Matlab.

+ Exposure to working with and manipulating large datasets

Qualifications:

+ A B.S. with 4+ years relevant work experience, a M.S. with 2+ years relevant work experience, or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences/Pharmacy, Biomedical Engineering, Bioinformatics, Data Sciences, Mathematics, or related STEM discipline

Other Qualifications:

+ Demonstrated commitment to problem solving and developing creative solutions

+ Detail oriented to ensure accuracy and thoroughness of work

+ Ability to multi-task

+ Ability to adapt to fast-moving timelines and quick turnaround times

+ Strong written and oral communication skills

+ Strong drive to learn and apply emerging technologies such as AI, ML, or other tools to improve daily task efficiencies

**Travel:** N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.