Senior Specialist, Quantitative Systems Pharmacology; QSP - Oncology

Job Description

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). The 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.

• 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).

• Ph.D., or equivalent degree OR a Pharm
  
  D 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 mechanistic modeling for antibody drug conjugates (ADCs), bispecifics, and/or T‑cell engagers will be preferred.
• Experience with modeling and simulation packages or programming languages (e.g., MATLAB/Sim Biology, QSP Designer, R).
• Hands‑on experience building, calibrating, and validating QSP models.
• Professional working proficiency in written and verbal communication.

The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid. Please note that standard commute is (less than) 50 miles.

Required Skills:

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

Preferred

Skills:

Antibody Drug Conjugates (ADC), Clinical Development, Clinical Pharmacology, Pharmacometrics, T Cells

US and Puerto Rico Residents Only:
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