Senior Director, Advanced Pharmacometrics, Quantitative Pharmacology, Immuno-Oncology

Responsibilities

• 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.
• Oversee development of advanced pharmacometrics modeling including but not limited to population PK/PD, tumor dynamics and survival modeling, 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.
• Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
• Foster a culture of scientific rigor, excellence, collaboration, and innovation.
• Collaborate with QP2 leads to design efficient, model‑informed clinical trials.
• Contribute to regulatory strategy through preparation of pharmacometric reports, briefing documents, and presentations.

Requirements

• Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or a related discipline with at least 10 years of pharmaceutical drug development experience, including substantial experience in pharmacometrics roles.
• OR Master’s, PharmD, or equivalent degree with at least 15 years of pharmaceutical drug development experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.
• Extensive and in‑depth experience in application of MIDD in oncology drug development to drive impactful development decisions.
• Deep proficiency in advanced pharmacometrics methods such as Bayesian hierarchical models, joint models of tumor and survival, drop‑out models, MBMA, advanced clinical trial simulation methods, integrating PROs and RWD into traditional NLME approaches.
• Hands‑on experience with software such as NONMEM, Pumas, Stan, R, and/or other Bayesian platforms.

Core Competencies

Demonstrates expertise in quantitative pharmacology and advanced pharmacometrics, with a strong focus on oncology drug development and regulatory compliance. Proven ability to lead teams, develop innovative modeling strategies, and collaborate effectively across multidisciplinary functions.