Associate Director, Clinical Pharmacology Modeling and Simulation Oncology

GSK•Waltham, PA

3d•Hybrid

About The Position

We have an exciting opportunity at GSK for a highly motivated and experienced quantitative clinical pharmacologist to join our Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group as part of the Oncology Translational Medicine department. GSK provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence. As Manager or Associate Director, CPMS, you will be part of a science-driven group delivering clinical pharmacology and modeling and simulation excellence to research and development programs. You’ll have the opportunity to work on small molecules, biologics, antibody-drug conjugates, T cell engagers and other new modalities in the Oncology therapeutic area. CPMS responsibilities generally span from approximately 6 months prior to FTIH through to submission and life cycle management.

Requirements

A doctorate (PharmD, PhD, MD) or master’s degree in quantitative clinical pharmacology and pharmacometrics disciplines (e.g., pharmacology, engineering or statistics)
2+ years of experience utilizing skills in population PK, exposure-response, mechanistic PKPD and/or longitudinal disease modeling to solve practical problems in industry or academia
Experience in pharmacometric tools such as NONMEM, Monolix, and/or R
2+ years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.

Nice To Haves

Experience in Oncology Research and Development
Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers
Passion for quantitative clinical pharmacology and desire to innovate for better outcome
Track record of implementation of Model-Informed Drug Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs
Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design
Experience in leveraging AI/ML for pharmacometrics and/or MIDD
Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results
Clear evidence of ability to use sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks
Experience working with senior stakeholders in a cross-functional environment

Responsibilities

Planning, conducting and reporting population pharmacokinetic modeling, exposure-response analysis, simulation-based trial design and dose selection, and drug-disease modeling
Applying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiency
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labeling (with regards to the clinical pharmacology, modeling and simulation contents)
Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modeling and simulation contributions to the R&D pipeline
Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation