Director of Clinical Pharmacology Modeling and Simulation

GSK; Upper Providence (Delaware County); Hybrid; USD 180,000 - 280,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Pension plan

Shares and savings programme

Hybrid work model

Job summary

GSK seeks a hands-on Quantitative Clinical Pharmacologist to lead clinical pharmacology and modelling across infectious disease programmes in the US. This senior IC role combines hands-on pharmacometrics with strategic leadership, focusing initially on an oral antibiotic lifecycle programme and broader bacterial/viral assets.

This hybrid position requires on-site collaboration with remote work flexibility; relocation plans for Stevenage/ Cambridge timelines are noted, with potential future

Qualifications

• Advanced degree in life sciences with quantitative focus.
• Extensive experience in human clinical pharmacology and pharmacokinetics.

Responsibilities

• Provide pharmacology leadership across infectious disease assets.
• Develop and justify dosing and exposure-response relationships.
• Create and apply PK/PD and M&S models to support development decisions.
• Present model-based evidence to governance and regulatory bodies.

Skills

Advanced degree

Clinical pharmacology experience

Education

PhD, PharmD or MD

Job description

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Director of Clinical Pharmacology Modeling and Simulation

We have an exciting opportunity at GSK for a hands-on Quantitative Clinical Pharmacologist to join our team supporting infectious disease clinical development and lifecycle management programmes.

GSK provides a supportive environment for scientists to learn, contribute and influence important development decisions through innovation, technical expertise and collaboration.

You will be part of a science-driven group delivering clinical pharmacology and modelling & simulation excellence across research and development programmes. This is a senior individual contributor role with no formal line-management responsibility. You will act as the Clinical Pharmacology, Modeling and Simulation lead for assigned assets, combining hands-on pharmacometrics with strategic leadership. Your initial focus will include an important oral antibiotic lifecycle programme, with opportunities to support a broader portfolio of bacterial and viral assets. Responsibilities may span early clinical planning, late-stage development, registration and lifecycle management.

This senior role is based in the United States. It is hybrid, combining regular on-site collaboration with remote work flexibility. You will need to be available for on-site meetings as required. For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Key Responsibilities

• Act as the Clinical Pharmacology, Modeling and Simulation representative on cross-functional medical development teams, shaping strategy for assigned infectious disease assets.
• Apply clinical pharmacokinetic, pharmacodynamic and modelling & simulation principles to support efficient clinical development, risk management, registration and lifecycle management.
• Play a central role in selecting and justifying doses and dosing regimens, including characterising exposure-response relationships and recommendations for relevant patient populations.
• Develop and apply population PK, PK/PD and exposure-response models, and conduct simulations to inform clinical trial design and development decisions.
• Present clinical pharmacology strategy and model-based evidence to governance boards, development teams and regulatory agencies.
• Apply relevant regulatory guidance to clinical pharmacology plans, study designs, analyses and development strategies.
• Advance model-informed drug development through high-quality scientific collaboration, external engagement, publication and conference presentation where appropriate.
• Design and interpret clinical pharmacology studies evaluating intrinsic and extrinsic factors affecting pharmacokinetics and pharmacodynamics.
• Identify appropriate opportunities to apply PBPK and other in silico approaches to evaluate drug interactions and special populations.
• Author and contribute to clinical development and regulatory documents, including protocols, reports, investigator brochures, briefing books, clinical pharmacology summaries and submission packages.
• Contribute clinical pharmacology evidence throughout regulatory interactions, from development-stage meetings through registration and product labelling.
• Learn and apply emerging modelling and simulation methodologies to improve programme efficiency and the quality of investment and development decisions.
• Collaborate effectively with clinicians, statisticians, biologists, regulatory colleagues, drug metabolism scientists and other matrix partners.
• Remain hands-on with quantitative analyses while providing strategic scientific leadership and clear recommendations to stakeholders.

Why you?

Basic Qualifications & Skills

• Advanced degree in a relevant life science discipline, such as a PhD, PharmD or MD, supporting a successful career in quantitative clinical pharmacology within pharmaceutical research and development.
• Substantial experience in human clinical pharmacology, clinical pharmacokinet