Sr. Scientist, Clinical Pharmacology

Triveni Bio•Watertown, MA

8d•$160,000 - $175,000

About The Position

Triveni Bio is seeking a motivated, detail-oriented Senior Scientist to join its Clinical Pharmacology team. In this hands-on role, the scientist will contribute to data analysis, modeling, and operational tracking across clinical-stage and pipeline programs. The role works closely with Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, and external partners to generate data and insights that inform dose selection, study design, and development decisions. The position reports to the Executive Director, Clinical Pharmacology. The role is intended for an early-career scientist seeking to expand hands-on quantitative clinical pharmacology skills in biologic drug development. Work includes non-compartmental analysis, population PK/PD and exposure-response analysis, bioanalytical strategy and data management, clinical study team participation, and support for regulatory and development documents.

Requirements

Ph.D. or M.S. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, Biomedical Sciences, or a related scientific discipline.
At least 2 years of relevant industry experience with a Ph.D. or 5 years with an M.S. 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.
Ability to travel up to 10% as needed.

Nice To Haves

Experience contributing to regulatory documentation.

Responsibilities

Support 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 such as Monolix or R.
Execute data assembly, dataset generation, and preliminary quantitative analyses for population PK/PD and exposure-response modeling using R, Monolix, or equivalent platforms.
Generate 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 Clinical Pharmacology.
Collaborate with internal teams and external vendors to ensure timely execution of clinical pharmacology analyses and deliverables.
Assist in preparing and reviewing clinical study protocols, statistical analysis plans, clinical study reports, and other development documents.
Support preparation of clinical pharmacology components of regulatory submissions and health authority responses.
Contribute to model-informed drug development activities and pharmacometric analyses in 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.
Perform other duties as assigned.