DIRECTOR CLINICAL PHARMACOLOGY LIFECYCLE MANAGEMENT

Site Name.
UK - London, Belgium, Switzerland - Zug, Upper Merion, Upper Providence Posted Date.
Dec A fantastic opportunity is available within GSK's Clinical Pharmacology Lifecycle Management team for an experienced individual who will provide clinical pharmacology, therapeutic, and regulatory support for G SK portfolio.
You will ensure optimal application of c linical p harmacokinetic (PK), p harmacodynamic (PD), and m odelling & s imulation (M&S) principles towards efficient evidence generation for the registration and life-cycle management of medicinal products.
Main accountabilities include.
• Integration of clinical pharmacology and PKPD principles into clinical development and life-cycle management plans and product strategies • Support accelerated regu l atory filing activities across multiple regions/markets, with focus on country-specific requirements.
• Preparation, authoring and review of CTD modules (e.
., .
and 2.
.
) taking into account relevant regulatory requirements for effective submissions and approval of new products, indications and/or relevant label extensions.
• Identification of opportunities for the use of model-based approaches for evidence generation in life-cycle management, as appropriate  • Developing and/or maintaining 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 • Developing and maintaining contact with internal and external scientific experts • With appropriate guidance contribute to clinical pharmacology protocol design, data analysis, interpretation and reporting of clinical PK, PKPD, and population PKPD modelling and simulation • Review and update of t he 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.
., biology, formulations, statistics) into CPMS technical activities and drug development strategy  • Understanding of relevant country-specific regulatory guidelines (e.
..
ANVISA), in addition to FDA, EMA and ICH guidelines • Implementation of paediatric investigation plans (PIPs) and paediatric study plans (PSPs), ensuring effective global programs and implications for clinical development plans and strategy for  the indication in adults.
• Adhere to best practices and learnings from internal and external sources Why you? Basic Qualifications.
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 Experience and understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities Preferred Qualifications.
If you have the following characteristics, it would be a plus.
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, organ impairment, and other special populations (e.
.
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 E xperience 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 modelli ng Excellent written (scientific and non-technical) communication skills in English Being a team player and functioning effectively in a matrix team setting When applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role.
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