Senior Specialist, Quantitative Systems Pharmacology (QSP) - Oncology

Merck•Upper Gwynedd Township, PA

6d•Hybrid

About The Position

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Senior Specialist, Quantitative Systems Pharmacology (QSP). QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration. The Senior Specialist within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to the development of novel therapeutics. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners if work is outsourced, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.

Requirements

Ph.D., or equivalent degree OR a PharmD or equivalent degree with at least two years of experience OR Masters or equivalent degree with four years of pharmaceutical or academic experience relating to: systems biology/pharmacology, mechanistic PKPD, mathematics, chemical/biomedical engineering or related field.
Experience in developing mechanistic PK-PD models and QSP models for decision making in early and/or late-stage clinical development
Experience with modeling and simulation packages or programming languages (e.g., MATLAB/SimBiology, QSP Designer, R)
Hands on experience building, calibrating, and validating QSP models
Professional working proficiency in written and verbal communication.
Biopharmaceutics
Data Analysis
Data Modeling
Data Science
Data Visualization
Drug Development
Pharmacodynamics
Pharmacokinetics
Pharmacology
PKPD Modeling
Quantitative Biology
Simulation Models
Stakeholder Relationship Management
Systems Biology

Nice To Haves

Experience with mechanistic modeling for antibody drug conjugates (ADCs), bispecifics, and/ or T-cell engagers will be preferred
Antibody Drug Conjugates (ADC)
Clinical Development
Clinical Pharmacology
Pharmacometrics
T Cells

Responsibilities

Serving as a QSP expert for QP2 -IO for developing and executing model-based analyses including QSP models and mechanistic PK/PD models into programs thereby strengthening our quantitative capabilities on a continuous basis in decision making and driving pipeline impact.
Bringing forward combination drug approaches by leveraging QSP models to design and prioritize combination clinical trials
Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians and other line functions to improve our understanding of disease mechanisms and modalities
Experience with QSP modeling in oncology for different modalities (small molecules,monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics).