Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology

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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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Position Summary

We have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS quantitative excellence to development programs helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients at the right dose and at the right time. 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 a Director CPMS Oncology you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. Youll have the opportunity to work on antibody drug conjugates biologics and small molecules in the Oncology therapeutic area. CPMS responsibilities generally start post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to 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:

• Defining and executing model-based development strategies for oncology projects

• Planning conducting and reporting of population PK and exposure-response analyses simulation-based trial design and dose selection

• 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

• Writing or reviewing clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology modelling and simulation contents)

• Interacting with line and middle management staff and external contacts on a functional strategic and tactical level

• Applying innovative methods such as drug-disease modeling longitudinal exposure-response analysis model-based meta-analysis quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency

• Implementing best practices trends lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline

• 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:

• PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g. pharmacology engineering or statistics) and experience in using modeling/simulation to solve practical problems in industry or academia. PharmD or Masters degree in the same disciplines with an additional 3 years of relevant experience may be considered.

• 5 years of utilizing and leveraging population PK and exposure-response modelling in drug development; and verifiable proficiency in pharmacometric tools NONMEM or R.

• 3 years of experience in planning performing and reporting model-based analysis of clinical data per industry and regulatory standards.

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

• Oncology drug development experience

• Knowledge of or ability to quickly learn disease biology mechanisms trial design endpoints and treatment paradigms in oncology

• Solid experience with advanced pharmacometric approaches such as mechanistic PKPD modelling longitudinal disease modeling model-based meta-analysis or adaptive dosing simulations

• Ability to keep up-to-date with and propose the implementation of new modeling approaches to inform drug development

• Experience with AI/ML tools and applications in pharmacometrics

• 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 make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks

• Experience in the design analysis interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards

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

• Experience working with senior stakeholders in a cross functional environment

• Excellent interpersonal skills with strong oral/written communication and presentation skills

• 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

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Skills

Antibody Drug Conjugates (ADC) Biologics Biomarker Research Biomarkers Clinical Oncology Clinical Pharmacology Clinical Trial Designs Data Science Interpersonal Communication Machine Learning (ML) Modeling Software NONMEM Oncology Oncology Research Oncology Trials Pharmacology Pharmacology Research Pharmacometrics PKPD Modeling Quantitative Analysis Quantitative Models Regulatory Interactions R Programming Simulation Modeling Simulation Programming

If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $188100 to $313500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country the relevant compensation will be discussed during the recruitment process.

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 were 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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Director