Director, Quantitative Pharmacology and Pharmacometrics, Oncology (Hybrid)

Job Description

Role and Responsibilities:

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director, 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. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.

Primary 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.

• Assisting asset development teams in bringing forward combination drug approaches by leveraging QSP models to design and prioritize combination clinical trials

• Broad understanding of population pharmacokinetic models and exposure-response models for application in clinical development

• Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians and other line functions to improve our understanding of disease mechanisms and modalities

• Framing critical questions and strategy for optimizing model-based analyses on programs.

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.

Minimum education required:

• Ph.D., with at least seven years of pharmaceutical drug development experience relating to: systems biology, PKPD, pharmacometrics, mathematics, chemical/biomedical engineering or related field.

• Masters or PharmD, with at least nine years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.

Required Experience:

• 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) and/ or T-cell engagers will be preferred

• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.

• Experience with modeling and simulation packages or programming languages (e.g., MATLAB, R, SimBiology, C/C++)

• Experience working with external QSP vendors

• Familiarity with R NONMEM, WINNONLIN or other similar programing language

• Professional working proficiency in written and verbal communication.

• Experience in IND, NDA and other submissions to global regulatory agencies.

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.

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