Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology

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

• Defining and executing model-based development strategies for oncology projects

• Planning, conducting and reporting of population PK and exposure-response analyses, simulation-based trial design and dose selection

• 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

• Writing or reviewing 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)

• Interacting with line and middle management, staff and external contacts on a functional, strategic and tactical level

• 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

• Implementing best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline

• Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modeling/simulation to solve practical problems in industry or academia. PharmD or Master’s degree in the same disciplines with an additional 3 years of relevant experience may be considered.

• 5+ years of utilizing and leveraging population PK and exposure-response modelling in drug development; and verifiable proficiency in pharmacometric tools NONMEM or R.

• 3+ years of experience in planning, performing, and reporting model-based analysis of clinical data per industry and regulatory standards.

If you have the following characteristics, it would be a plus:

• Oncology drug development experience

• Knowledge of or ability to quickly learn disease biology, mechanisms,  trial design, endpoints and treatment paradigms in oncology

• Solid experience with advanced pharmacometric approaches such as mechanistic PKPD modelling, longitudinal disease modeling, model-based meta-analysis, or adaptive dosing simulations

• 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

• 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

• 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

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Skills

Antibody Drug Conjugates (ADC), Biologics, Biomarker Research, Biomarkers, Clinical Oncology, Clinical Pharmacology, Clinical Trial Designs, Data Science, Interpersonal Communication, Machine Learning (ML), Modeling Software, NONMEM, Oncology, Oncology Research, Oncology Trials, Pharmacology, Pharmacology Research, Pharmacometrics, PKPD Modeling, Quantitative Analysis, Quantitative Models, Regulatory Interactions, R Programming, Simulation Modeling, Simulation Programming

• 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 $188,100 to $313,500. 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.