Director, Quantitative Pharmacology and Pharmacometrics Immune/Oncology (Remote) Position Available In Davidson, Tennessee

• 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. _This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, please see requisition_ _”#R345560″._ _Please note that standard commute is (less than)