Manager/Associate Director Clinical Pharmacology Lifecycle Management

Site Name: UK – London – New Oxford Street, Home Worker – USA, Zug House Posted Date: Dec 3 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Are you energized by a role that requires strategic thinking and extensive internal and external engagement? If so, this Manager/Associate Director Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore. The Manager/Associate Director Clinical Pharmacology Lifecycle Management will provide clinical pharmacology, therapeutic and regulatory support for GSK’s product portfolio worldwide. The individual will also contribute to the evidence generation plans for new and existing medicinal products. Offer would be dependent on experience of candidate offered. In this role you will Ensure integration of clinical pharmacology and PKPD principles into clinical development, regulatory approval and life-cycle management of GSK products. Support accelerated regulatory filing activities across multiple regions/markets, with focus on country-specific requirements. Lead the preparation, authoring and review of CTD modules taking into account country-specific regulatory requirements for effective submissions and approval of new products, indications and/or relevant label extensions. Develop and maintain a strong working knowledge of pharmacology, physiology, clinical pharmacology, therapeutics, and statistics, such that adequate expertise and support is provided to business partners and project teams With appropriate guidance contribute to the design, data analysis, interpretation and reporting of clinical pharmacology studies. With appropriate guidance implement, analyse and report PK, PKPD, and drug-disease modelling and simulation studies. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: PhD and/or MD degree in clinical pharmacology or other relevant discipline (e.g. Pharmaceutical Sciences, Bioengineering, Pharmacy) Relevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical company Understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities Project management experience Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics and commercialization such that he/she can assist in managing these interfaces and promote a strong partnership with Medical Affairs, Clinical Safety and other relevant business partners. Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies, including bioequivalence, concentration-QT, drug-drug interaction, organ impairment, and other special populations (e.g. Japanese, older adults) Working knowledge in standard and innovative clinical study protocol design across different phases of development and life-cycle management, including evaluation of real-world evidence Experience in quantitative clinical pharmacology, including population PK modelling, drug-disease modelling, clinical trial simulations, and dosing algorithms Understanding of statistical methodologies: ANOVA, hypothesis testing, Bayesian inference, nonlinear mixed-effects modelling Proven performance in a matrix team environment Closing Date for Applications – Tuesday 17th December 2024 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. 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). 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