Senior Director, Advanced Pharmacometrics, Quantitative Pharmacology and Pharmacometrics - Immu[...] (Rahway)

Job Description

We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO) team as Senior Director, Advanced Pharmacometrics . QP2‑IO is part of the Global Clinical Development organization and is responsible for clinical pharmacology and pharmacometrics strategy and execution for oncology assets, from candidate nomination through registration.

Primary Responsibilities

Strategic Leadership

• Lead quantitative pharmacology strategy across the oncology portfolio, ensuring alignment with program goals and organizational priorities.
• Develop and implement long‑range plans for integrating MIDD, pharmacometrics, data science, and Bayesian modeling approaches to accelerate and de‑risk oncology drug development.
• Partner with senior leaders in Clinical Development, Translational Medicine, Biostatistics, Regulatory, and Data Science to define modeling strategies that influence program design and key decisions.

Scientific & Technical Leadership

• Oversee development of advanced pharmacometrics modeling including population PK/PD, tumor dynamics and survival modeling, and advanced models to inform dose selection, clinical design, and benefit–risk assessments.
• Champion the use of Bayesian methods, including hierarchical and joint modeling, and prior‑data integration to strengthen oncology decision‑making.
• Ensure high‑quality, regulatory‑grade pharmacometric deliverables for submissions, label negotiations, and scientific advice meetings.
• Stay at the forefront of emerging methodologies, including AI/ML, and promote innovation in modeling tools, computational frameworks, and analytics platforms.

Team Leadership & Development

• Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
• Foster a culture of scientific rigor, excellence, collaboration, and innovation.

Cross‑Functional Collaboration

• Collaborate with QP2 leads to design efficient, model‑informed clinical trials.
• Work closely with Translational, Clinical, Biostatistics functions to integrate advanced modeling into decision frameworks.

Regulatory & External Engagement

• Contribute to regulatory strategy through preparation of pharmacometric reports, briefing documents, and presentations.
• Represent the company at scientific conferences, external collaborations, consortia, and industry working groups.