Director of Clinical Pharmacology Modeling and Simulation

GSK has an inspiring ambition : by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI / ML.Job Purpose : We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease area as part of the global department of Clinical Pharmacology Modelling & Simulation. GlaxoSmithKline 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 of Clinical Pharmacology Modelling and Simulation (CPMS) 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 both small molecules and biologics in the Vaccines and Infectious Disease therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. Key Responsibilities : This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program, robust registration package and support life cycle management of an assetProvide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compoundsPlay a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for special populations.Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performancePresent strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agenciesProvide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategyPromote model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation.Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamicsIdentify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriateWrite sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packagesLearn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology applicationInnovate through working effectively with colleagues in the department and other matrix team members, including : statisticians, biologists, physicians and drug metabolism scientistsWhy you?Basic Qualifications : We are looking for professionals with these required skills to achieve our goals : Advanced Degree in Lifesciences such as PhD, PharmD or MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development5 years experience in clinical pharmacokinetics, modelling & simulation and model-informed drug development including designing, analysing and reporting clinical studiesExperience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalentExperience working with common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, SIMCYP, SAS and MATLAB through previous hands-on projectsExperience with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs through direct involvement in regulatory submission activities in previous rolesExperience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studiesPreferred Qualifications : If you have the following characteristics, it would be a plus : Demonstrated expertise in specific technical areas related to modelling and simulation, and / or the vaccines and infectious disease therapeutic areaKnowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in infectious disease and other relevant therapy areasAbility to communicate clearly and succinctly with the audience in mind, both orally and in writingAbility to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology resultsSound judgement, analytical mindset and problem-solving skillsAbility to effectively multi-task and deliver results on time#LI-GSK

• Please visit GSK US Benefits Summaryto 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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.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 GSK’s Transparency Reporting For the Record site.SummaryLocation : Durham Blackwell Street; Waltham; Upper ProvidenceType : Full time