Manager Clinical Pharmacology Lifecycle Management

Are you energized by a role that requires strategic thinking and extensive internal and external engagement?  If so, this Manager Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore.

The Manager 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. 

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 practises; 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

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.
• Identify opportunities for the use of model-based approaches for evidence generation in life-cycle management, as appropriate 
• 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.
• Review and update of the clinical pharmacology components of regulatory documents and responses such that GSK and ViiV products are approved with optimum labelling 
• Integrate relevant information from nonclinical disciplines (e.g., biology, formulations, statistics) into CPMS technical activities and drug development strategy 
• Contribute to the implementation of paediatric investigation plans (PIPs) and paediatric study plans (PSPs), enabling effective use of extrapolation approaches across global programs

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 similar discipline
• 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

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 – Friday 13th September 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. 

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.? We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. 

Find out more: 

Our approach to R&D.??? 

Als Unternehmen, das von den Werten Patientenorientierung, Transparenz, Respekt und Integrität geleitet wird, wissen wir, dass Inklusion und Vielfalt für unseren Erfolg unerlässlich sind. Wir möchten, dass alle unsere Kollegen bei GSK gedeihen und ihre einzigartigen Erfahrungen einbringen, damit sie sich wohlfühlen und ihre Karriere fortsetzen können. Als Kandidat für eine Rolle möchten wir, dass Sie sich genauso fühlen.

Wir glauben an eine agile Arbeitskultur für alle unsere Rollen. Wenn Flexibilität für Sie wichtig ist, empfehlen wir Ihnen, gemeinsam mit unserem Einstellungsteam nach den Möglichkeiten zu suchen.

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