Manager/Associate Director, CPMS Oncology

GSK has an inspiring ambition: by uniting science, technology and talent, we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML.

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, and antibody-drug conjugates 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.

This role will provide YOU the opportunity to contribute and 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 Qualifications:

We are looking for professionals with these required skills to 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 or more 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; verifiable proficiency in pharmacometric tools NONMEM, Monolix, or R

• 2 or more years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.

Preferred Qualifications:

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

• Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results

• Prior experience in Oncology Research and Development is a plus

• Prior experience in leveraging AI/ML for pharmacometrics and/or MIDD

• Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design

• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers

• Clear evidence of ability to use sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks

• Passion for quantitative clinical pharmacology and desire to innovate for better outcome

• Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs

• Experience working with senior stakeholders in a cross-functional environment

Work Locations:

USA - Pennsylvania - Upper Providence; USA - Massachusetts - Waltham; USA - North Carolina - Durham

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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