Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology

Business IntroductionAt 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&DPosition SummaryWe have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time. 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 a Director, CPMS Oncology, you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on antibody drug conjugates, biologics and small molecules in the Oncology therapeutic area. CPMS responsibilities generally start post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. Working arrangementThis 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.ResponsibilitiesThis 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 projectsPlanning, conducting and reporting of population PK and exposure-response analyses, simulation-based trial design and dose selectionPresenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agenciesContributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissionsWriting 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 levelApplying 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 efficiencyImplementing best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipelinePromoting model-informed drug discovery and development through external collaboration, journal publication and conference presentationWhy You?Basic QualificationWe 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.Preferred QualificationIf you have the following characteristics, it would be a plus:Oncology drug development experienceKnowledge of or ability to quickly learn disease biology, mechanisms, trial design, endpoints and treatment paradigms in oncologySolid experience with advanced pharmacometric approaches such as mechanistic PKPD modelling, longitudinal disease modeling, model-based meta-analysis, or adaptive dosing simulationsAbility to keep up-to-date with and propose the implementation of new modeling approaches to inform drug developmentExperience with AI/ML tools and applications in pharmacometricsDemonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of resultsClear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasksExperience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standardsPassion for quantitative clinical pharmacology and desire to innovate for better outcomeExperience working with senior stakeholders in a cross functional environmentExcellent interpersonal skills with strong oral/written communication and presentation skillsStrong 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#GSK-LISkills• 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. 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 - View email address on click.appcast.io 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at SummaryLocation: USA - Pennsylvania - Upper Providence; USA - Massachusetts - Waltham; USA - North Carolina - DurhamType: Full time