Director, Oncology Clinical Pharmacology, Modeling and Simulation
This position requires an on‑site office presence for 2–3 days per week and offers an exciting opportunity for a highly motivated and experienced Director to join our Oncology Translational Medicine team. The role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies that reach the right patients at the right dose and at the right time.
Responsibilities
* Defining and executing model‑based development strategies for oncology projects.
* Planning, conducting and reporting exposure‑response analysis, simulation‑based trial design, dose selection, and population PK modelling.
* Applying innovative methods such as drug‑disease modelling, 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 model‑based outcomes 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 so GSK products are rapidly and efficiently approved with optimum labelling.
* Implementing best practices, trends and lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to the R&D pipeline.
* Interacting 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.
* Working across matrix teams to innovate in methodologies, design efficiencies and create value.
Basic Qualifications
* PhD in Quantitative Clinical Pharmacology, Pharmacometrics, engineering, statistics or a related life‑sciences discipline with experience using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master’s degree with an additional four years of relevant experience may also be considered.
* Five or more years of utilizing skills in mechanistic PKPD and longitudinal disease modelling, with verifiable proficiency in pharmacometric tools such as NONMEM or R.
* Three or more years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards.
* Expertise in applying AI/ML to clinical pharmacology and pharmacometric analyses with innovative methodologies and efficiency applications.
Preferred Qualifications
* Strong drive and learning agility to build knowledge on drug‑disease systems, symptom progression, standard of care and trial design.
* Knowledge of or the 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 modelling approaches to inform drug development.
* Demonstrated aptitude for productive collaboration in a multi‑discipline team, with effective communication and 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 prioritising 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 outcomes.
* 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 implementing model‑informed drug development (MIDD) approaches to accelerate patient access to novel therapies and expand therapeutic indications of marketed drugs.
Compensation and Benefits
Annual base salary for new hires ranges from $0 to $0, depending on work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. The position also offers an annual bonus and eligibility to participate in our share‑based long‑term incentive programme.
Benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Why GSK
GSK is a global biopharma company dedicated to uniting science, technology and talent to get ahead of disease. We aim to positively impact the health of 2.5 billion people over the next decade through innovative medicines and vaccines in four therapeutic areas, including oncology.
If you require accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
GSK is an Equal Opportunity Employer. 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, military service or any basis prohibited under federal, state or local law.
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