Director Clinical Pharmacology Lifecycle Management
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 GSK portfolio.
You will ensure optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling & simulation (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 regulatory filing activities across multiple regions/markets, with focus on country-specific requirements.
• Preparation, authoring and review of CTD modules (e.g., 2.7.1., 2.7.2. and 2.7.5) 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 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
• Understanding of relevant country-specific regulatory guidelines (e.g.. 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, includingbioequivalence, concentration-QT, 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
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.
*LI-GSK
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.
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