Sr. Scientist, Clinical Pharmacology

SUMMARY 

We are seeking a motivated, detail-oriented Senior Scientist to join our Clinical Pharmacology team. In this hands-on role, you will contribute directly to data analysis, modeling, and operational tracking across our clinical-stage and pipeline programs. Working closely with cross-functional teams, you will perform non-compartmental analyses (NCA), population PK/PD modeling, help define and implement bioanalytical strategies, manage bioanalytical data, and actively participate in clinical study team meetings. This is an exciting opportunity for an early-career scientist with 2–3 years of experience looking to expand their skills in hands-on quantitative clinical pharmacology and biologic drug development. Reporting into the Exec. Director, Clinical Pharmacology, and working closely with Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, and external partners, the Senior Scientist will help generate data and insights that inform dose selection, study design, and key development decisions.

RESPONSIBILITIES 

• Support the development and implementation of clinical pharmacology plans for clinical development programs
• Contribute to the design of PK, PD, biomarker, immunogenicity, and exposure-response assessments in clinical studies
• Perform Non-Compartmental Analysis (NCA) using standard software (e.g., Monolix or R) to support clinical study.
• Execute data assembly, dataset generation, and preliminary quantitative analyses for Population PK/PD (popPK/PD) and exposure-response modeling using R, Monolix, or equivalent platforms.
• Generate high-quality graphical visualizations and summary tables of clinical PK/PD for internal study team updates.
• Attend and participate in cross-functional clinical study team meetings, representing the Clinical Pharmacology function.
• Collaborate with internal teams and external vendors to ensure timely execution of clinical pharmacology analyses and deliverables
• Assist in the preparation and review of clinical study protocols, statistical analysis plans, clinical study reports, and other development documents
• Support the preparation of clinical pharmacology components of regulatory submissions and health authority responses
• Contribute to model-informed drug development activities and pharmacometric analyses through collaboration with internal and external experts
• Present study results and data interpretations to project teams and functional leadership
• Maintain knowledge of current scientific, regulatory, and industry trends in clinical pharmacology and pharmacometrics
• Other duties as assigned

EXPERIENCE & QUALIFICATIONS 

• Ph.D. or M.S. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, Biomedical Sciences, or a related scientific discipline
• 2+ years (Ph.D.) or 5+ years (M.S.)  years of relevant industry experience in biotechnology, pharmaceutical, or CRO environments; postdoctoral experience may be considered
• Proficiency with R for data manipulation, statistical reporting, and data visualization. Hands-on experience or academic exposure to pharmacometric platforms such as Monolix, or NONMEM.
• Experience supporting clinical development programs, preferably involving biologics, antibodies, or immunology/inflammation therapeutics
• Knowledge of PK, PD, exposure-response relationships, immunogenicity assessments, and clinical pharmacology principles
• Experience working with external CROs and bioanalytical laboratories
• Strong scientific communication and data presentation skills
• Experience contributing to regulatory documentation is preferred
• Ability to travel up to 10% as needed