Associate Director, Clinical Pharmacology Modeling and Simulation Oncology

GSK; Upper Providence (Delaware County); Hybrid; USD 180,000 - 230,000; Full time

Job summary

GSK is seeking a highly motivated quantitative clinical pharmacologist to join our Oncology CPMS group within Oncology Translational Medicine. As part of a science-driven team, you will deliver clinical pharmacology and modeling expertise to support research and development programs, working with small molecules, biologics, and ADCs.

The role is hybrid, typically on-site 2–3 days per week, with flexibility to fit business needs and local policy.

Qualifications

• Doctorate or master's in quantitative clinical pharmacology/pharmacometrics.
• 2+ years experience using population PK, exposure–response, and longitudinal modeling.
• Experience with NONMEM, Monolix, and/or R.
• 2+ years designing, analyzing, and reporting clinical pharmacology studies per regulatory standards for associate director level.

Responsibilities

• Lead population PK, exposure–response analyses, and dose selection modeling.
• Apply longitudinal exposure–response analysis and model-based meta-analysis.
• Present strategy and defend model-based approaches to governance boards.
• Contribute to study design, protocols, analysis plans, and regulatory submissions.
• Write clinical pharmacology sections of regulatory documents.
• Promote MIDD approaches and external collaborations.
• Interact with management and external contacts on strategic/tactical levels.
• Publish and present model-informed drug development findings.

Skills

Population PK

Exposure–response analysis

Longitudinal disease modeling

Regulatory communication

Education

Doctorate degree (PharmD, PhD, MD) in quantitative clinical pharmacology

Master's degree in related fields

Tools

NONMEM

Monolix

R

Job description

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Position Summary

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.

Working arrangement

This role is hybrid. You will typically be expected on-site 2 to 3 days per week, with flexibility according to business needs and local policy.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• 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 bus