Manager Clinical Pharmacology Modelling & Simulation

Site Name: Australia - NSW - Sydney Metro Posted Date: Aug 26 2022 Manager Clinical Pharmacology Modelling & Simulation Permanent Role 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Reporting to the Senior Director, Clinical Pharmacology Modelling and Simulation: Sydney & Ethnopharmacology Group Head, the Manager Clinical Pharmacology Modelling and Simulation will be an important team member within the Sydney Australia group in the CPMS Asia Hub, providing expertise in support of simultaneous drug development with respect to ethnic sensitivity assessment. This can include contributions to PK/PD and pharmacometric analyses as per Model Informed Drug Development good practices. A central focus will be contributing to early ethnic sensitivity assessment activities for global CPMS in support of simultaneous development in East Asian and global populations across identified projects. In this role the Manager will apply expertise with respect to relevant aspects of intrinsic and extrinsic factors determining variability in pharmacokinetics, pharmacodynamics, efficacy, and safety of GSK assets to inform both simultaneous and where necessary country specific development strategies and associated regulatory interactions. Your role will be varied and will include: Support early ethnic sensitivity profiling of GSK assets for a nominated indication while planning the FIH study and updating when initial human PK and PD data are available. Support discussion of potential consequences for development in North East Asia with project teams and LOCs in Asia. Support timely and accurate clinical pharmacology input to project teams as required to aid determination of appropriate global drug development strategies Develop documentation on ethnic sensitivity and the design of studies/research programs to further evaluate all aspects of ethnopharmacology. When appropriate, contribute to implementation of Model Informed Clinical Pharmacology strategies in the CPMS Asia Hub which contribute to the understanding of the ethnic sensitivity of GSK assets. Provide input to the evaluation of both the clinical and regulatory implications of intrinsic and extrinsic determinants of variability in pharmacokinetics, pharmacodynamics, efficacy and safety of GSK assets. Prepare timely and efficient responses to clinical pharmacology-related regulatory queries, including ethnopharmacology/ethnicity issues. To be successful in this role you will have: Significant research and clinical pharmacology skills A PhD is strongly preferred At least 4-years’ experience in clinical pharmacology. Experience in global clinical drug development and a sound understanding of regulatory requirements an advantage Demonstrated knowledge of Clinical Pharmacology concepts and potential to profile drivers of inter-ethnic differences in drug response is required. About Us Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and treatments, including innovative new products, will reach more people who need them than ever before. We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy. 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 our ambition for GSK to be 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 people 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 of Disease Together. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. GSK is a place where outstanding people do amazing things. We have clear values and expectations and we put them at the heart of everything we do. At GSK we believe in the power of an inclusive and diverse workforce. We aim to create an inclusive workplace where all employees feel engaged, supported and know that their work makes an important contribution. We are an equal opportunity employer and all applicants will be considered regardless of sexuality, religion, age, colour, ethnicity, gender identity or parental status. Aboriginal and Torres Strait Islander Australians are encouraged to apply for this position. GSK acknowledges the Traditional Custodians of the land in which we live, and we pay our respect to their Elders both past and present and emerging. *LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Important notice to Employment businesses/ Agencies GSK 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. 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