Associate Director, Clinical Pharmacology Modeling and Simulation Oncology

GSK; Waltham (MA); Hybrid; USD 148,000 - 246,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation time

Parental leave

Medical leave

Job summary

GSK in the United States seeks a highly qualified quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group. You will drive population PK modeling, exposure–response analyses, and model-based trial design.

The role spans from pre-FTIH to submission and lifecycle management, with hybrid on-site work 2–3 days per week. The candidate should have a PhD/PharmD/MD with 2+ years in pharmacometrics, familiarity with NONMEM/Monolix/R, and

Qualifications

• Doctoral degree (PharmD, PhD, MD) or master's in quantitative pharmacology/pharmacometrics.
• 2+ years in population PK, exposure–response, mechanistic PKPD, or longitudinal disease modeling.
• Experience using pharmacometric tools such as NONMEM, Monolix, and/or R.
• 2+ years in design, analysis, interpretation and reporting of clinical pharmacology studies per industry standards.

Responsibilities

• Plan, conduct, and report population PK modeling and exposure–response analyses; design dose–selection studies.
• Apply longitudinal exposure–response analysis and model-based meta-analysis to improve trial efficiency.
• Present model-based strategy to governance boards and regulatory agencies.
• Contribute to clinical program design, protocols, analysis plans, and regulatory submissions.
• Write/review clinical pharmacology sections of regulatory documents to support labeling.
• Implement best practices to advance modeling contributions to the R&D pipeline.
• Interact with management and external contacts on strategic and tactical levels.
• Promote model-informed drug development through external collaboration and publications.

Skills

Clinical Pharmacology

Modeling & Simulation

Pharmacokinetics

Pharmacodynamics

Pharmacometrics

Regulatory Compliance

Oncology

AI/ML in pharmacometrics

Education

PhD in quantitative pharmacology

PharmD or MD degree

Tools

NONMEM

Monolix

R

Job description

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 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

Position Summary

We have an exciting opportunity at GSK for a highly motivated and experienced quantitative clinical pharmacologist to join our Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group as part of the Oncology Translational Medicine department. 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 Manager or Associate Director, CPMS, you will be part of a science-driven group delivering clinical pharmacology and modeling and simulation excellence to research and development programs. You'll have the opportunity to work on small molecules, biologics, antibody-drug conjugates, T cell engagers and other new modalities in the Oncology therapeutic area. CPMS responsibilities generally span from approximately 6 months prior to FTIH through to submission and 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

• Planning, conducting and reporting population pharmacokinetic modeling, exposure-response analysis, simulation-based trial design and dose selection, and drug-disease modeling
• Applying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology 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 labeling (with regards to the clinical pharmacology, modeling and simulation contents)
• Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modeling and simulation contributions to the 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 Qualification

• A doctorate (PharmD, PhD, MD) or master's degree in quantitative clinical pharmacology and pharmacometrics disciplines (e.g., pharmacology, engineering or statistics)
• 2+ years of experience utilizing skills in population PK, exposure-response, mechanistic PKPD and/or longitudinal disease modeling to solve practical problems in industry or academia
• Experience in pharmacometric tools such as NONMEM, Monolix, and/or R
• 2+ years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.

Preferred Qualification

• Experience in Oncology Research and Development
• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers
• Passion for quantitative clinical pharmacology and desire to innovate for better outcome
• Track record of implementation of Model-Informed Drug Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs
• Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design
• Experience in leveraging AI/ML for pharmacometrics and/or MIDD
• 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 use sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks
• Experience working with senior stakeholders in a cross-functional environment.

#GSK-LI

Skills

Artificial Intelligence (AI), Clinical Development, Clinical Pharmacology, Drug Development, Drug Discovery Research, In Vitro Models, Modeling Simulations, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, 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 $147,675 to $246,125. 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.

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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