Director, Quantitative Pharmacology & Pharmacometrics - Oncology

4w1 month ago

MSD

Rahway, US · Full-time · $190,800 – $300,300

About this role

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director. The QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology 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 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 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.

This role offers the opportunity to mentor and supervise junior staff, helping them develop capabilities in pharmacometrics and quantitative drug development. Directors demonstrate outstanding leadership and communication skills while representing QP2-IO on Oncology development teams.

Requirements

Ph.D. with at least seven years of pharmaceutical drug development experience relating to PKPD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
Masters or PharmD with at least nine years of experience, with a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.
Demonstrated impact with applications of pharmacometrics methods.
Experience in IND, NDA and other submissions to global regulatory agencies.
Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software.
Professional working proficiency in written and verbal communication.

Responsibilities

Serving as an expert representative for QP2-IO on Oncology development teams.
Framing critical questions and strategy for optimizing model-based analyses on programs.
Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.
Strategizing and executing modeling of tumor size and survival.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology.
Authoring regulatory documents including INDs, CSRs, and CTDs, and representing QP2-IO at regulatory meetings.
Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.

Benefits

Opportunity to lead and mentor junior staff in a highly collaborative, cross-functional environment.
Work on novel chemical entities in oncology from post-PCC to registration.
Engage with external vendors and partners to shape quantitative drug development strategies.
Represent QP2-IO at global regulatory meetings and author key regulatory documents.