Senior Scientist, Clinical Pharmacology & PK/PD Modeling

Triveni Bio, Inc.; Watertown (MA); On-site; USD 160,000 - 175,000; Full time

Job summary

Triveni Bio, Inc. is seeking a Senior Scientist in Clinical Pharmacology to contribute to data analyses, modeling, and regulatory documentation across clinical-stage programs in a hands-on role. You will perform NCA, PK/PD modeling, and help define bioanalytical strategies while collaborating with cross-functional teams.

Reporting to the Exec. Director, Clinical Pharmacology, you will help inform dose selection and study design for biologics, with 2–3 years of hands-on quantitative clinical

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.) 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
• Ability to travel up to 10% as needed

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

Skills

Scientific communication

Data interpretation

Education

Ph.D. in Clinical Pharmacology or related

M.S. in related field

Tools

R

Monolix

NONMEM

Job description

Triveni Bio, Inc. is seeking a Senior Scientist in Clinical Pharmacology to contribute to data analyses, modeling, and regulatory documentation across clinical-stage programs in a hands-on role. You will perform NCA, PK/PD modeling, and help define bioanalytical strategies while collaborating with cross-functional teams.

Reporting to the Exec. Director, Clinical Pharmacology, you will help inform dose selection and study design for biologics, with 2–3 years of hands-on quantitative clinical