Director of Clinical Pharmacology Modeling and Simulation

GlaxoSmithKline; Waltham (MA); Hybrid; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonus

Healthcare programmes

Pension plan

Shares and savings programme

Hybrid work model

Job summary

GlaxoSmithKline seeks a senior quantitative clinical pharmacologist to lead modelling and simulation for infectious disease assets. You will combine hands-on pharmacometrics with strategic leadership, supporting early development through lifecycle management in a hybrid US-based role.

You will design and interpret studies, apply PBPK/PK–PD methods, and contribute to regulatory submissions while collaborating across clinical, regulatory and biostatistics teams.

Qualifications

• Advanced degree in life sciences (PhD/PharmD/MD) supporting quantitative pharmacology work.
• Substantial experience in human clinical pharmacology, PK, modelling & simulation and model-informed drug development.
• Hands-on experience applying population PK, PK/PD or exposure–response models to clinical questions.
• Experience with quantitative tools (NONMEM/Monolix, R) to inform development strategies.
• Experience contributing to regulatory interactions and regulatory documents.

Responsibilities

• Lead activities to progress clinical pharmacology strategies for infectious disease assets.
• Apply PK/PD and modelling to support development, risk management and lifecycle decisions.
• Characterise dose selection and dosing regimens using exposure-response analyses.
• Develop and apply population PK/PK–PD models and run simulations for trial design.
• Present strategy and model-based evidence to governance and regulatory teams.
• Collaborate with cross-functional teams and external partners; provide hands-on analyses.

Skills

Clinical pharmacology

PK/PD modelling

Model-informed development

NONMEM/Monolix

R

Regulatory interactions

Education

PhD/PharmD/MD in life sciences

Tools

NONMEM

Monolix

R

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.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

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:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• 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

We are looking for professionals with these required skills to achieve our goals:

• 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 pharmacokinetics, modelling & simulation and model-informed drug development, including the design, analysis and reporting of clinical studies.
• Demonstrated hands-on experience applying population PK, PK/PD or exposure-response models to clinical development questions.
• Practical experience with common quantitative clinical pharmacology tools, including NONMEM or Monolix and R.
• Experience using quantitative evidence to influence dose selection, clinical development plans and cross-functional programme decisions.
• Experience contributing to regulatory interactions or submission documents and applying relevant regulatory guidance to clinical development plans and studies.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Demonstrated expertise in pharmacometrics and modelling & simulation; experience in vaccines, infectious diseases or anti-infectives would be beneficial but is not essential.
• Knowledge of, or the ability to quickly learn, the mechanisms, endpoints, progression and treatment of diseases within infectious disease and other relevant therapy areas.
• Experience supporting late-stage clinical development, registration, lifecycle management, regulatory briefing books, dossiers or clinical pharmacology product labelling.
• Additional experience with Python, WinNonlin, Simcyp, SAS, MATLAB, PBPK or translational PK/PD approaches, alongside substantial human clinical development experience.
• Ability to communicate complex quantitative evidence clearly and succinctly, build effective collaborations and take personal accountability for delivery.
• Curiosity about emerging methodologies and technology, including high-performance computing and AI-enabled tools, with a willingness to learn and apply new approaches.

Closing Date for Applications - 27th September

#LI-GSK

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. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Skills

Animal Models, Artificial Intelligence (AI), Clinical Development, Clinical Pharmacology, Drug Design, Drug Development, Drug Discovery Research, In Vitro Models, In Vitro Research, Medication Safety, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacometrics, Regulatory Compliance

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 $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 appropriate Recruitment Staff by emailing us at - [e-mail].

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.

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