Director CPMS Oncology at GSK

Upper Providence, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

305250.0

Posted On

23 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quantitative Clinical Pharmacology, Pharmacometrics, Modeling, Simulation, Pharmacokinetics, Pharmacodynamics, AI, Machine Learning, Clinical Data Analysis, Oncology Research, Collaboration, Communication, Regulatory Submissions, Trial Design, Exposure-Response Analysis, Drug Development

Industry

Pharmaceutical Manufacturing

Description

Company Overview 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. GSK has kicked off 2025 with impressive growth in sales, profits, and earnings. We anticipate five major new FDA product approvals and 15 phase III/pivotal study readouts over the next two years. So far, we have secured two FDA approvals, with three more expected later this year. By uniting science, technology, and talent, we are committed to getting ahead of disease together. Job Purpose 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. 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. 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. You’ll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. This position requires an on-site office presence for 2-3 days per week. Key Responsibilities: Defining and executing model-based development strategies for oncology projects Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling 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 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 labelling (with regards to the clinical pharmacology, modelling and simulation contents) Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to 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: A PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master degree in the same disciplines with an additional 4 years of relevant experience may be considered. 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM or R 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards Preferred Qualifications: 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 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 is a plus 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 Prior experience in Oncology Research and Development is a plus 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 Company Overview 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. GSK has kicked off 2025 with impressive growth in sales, profits, and earnings. We anticipate five major new FDA product approvals and 15 phase III/pivotal study readouts over the next two years. So far, we have secured two FDA approvals, with three more expected later this year. By uniting science, technology, and talent, we are committed to getting ahead of disease together. Job Purpose 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. 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. 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. You’ll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. This position requires an on-site office presence for 2-3 days per week. Key Responsibilities: Defining and executing model-based development strategies for oncology projects Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling 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 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 labelling (with regards to the clinical pharmacology, modelling and simulation contents) Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to 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: A PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master degree in the same disciplines with an additional 4 years of relevant experience may be considered. 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM or R 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards Preferred Qualifications: 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 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 is a plus 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 Prior experience in Oncology Research and Development is a plus 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 #LI-GSK* The US annual base salary for new hires in this position ranges from $183,150 to $305,250 The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In 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 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Responsibilities

The Director will define and execute model-based development strategies for oncology projects, focusing on quantitative excellence in clinical pharmacology and modeling. Responsibilities include planning and conducting exposure-response analysis, simulation-based trial design, and contributing to clinical program design and regulatory submissions.