Associate Director, Clinical Pharmacology Modeling and Simulation 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 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 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:Planning, conducting and reporting population pharmacokinetic modeling, exposure-response analysis, simulation-based trial design and dose selection, and drug-disease modelingApplying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiencyPresenting 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 submissionsWrite 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 pipelineAbility to interact with line and middle management, staff and external contacts on a functional, strategic and tactical levelPromoting 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: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 modelingto solve practical problems in industry or academiaExperience in pharmacometric tools such as NONMEM, Monolix, and/or R2+ years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.Preferred QualificationIf you have the following characteristics, it would be a plus: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 outcomeTrack record of implementation of Model-Informed Drug Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugsStrong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial designExperience in leveraging AI/ML for pharmacometrics and/or MIDDDemonstrated 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 use sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasksExperience working with senior stakeholders in a cross-functional environment#GSK-LISkillsArtificial 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.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 job-api.jobget.com 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; Durham Blackwell StreetType: Full time