Clinical Pharmacology Lifecycle Management Director
2 weeks ago
We are seeking a highly skilled and experienced Clinical Pharmacology Lifecycle Management Director to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal products.
Main Accountabilities- Integration of Clinical Pharmacology and PKPD Principles: You will ensure the 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.
- Regulatory Support: You will provide support for accelerated regulatory filing activities across multiple regions/markets, with a focus on country-specific requirements.
- CTD Module Preparation: You will prepare, author, and review CTD modules (e.g., 2.7.1), taking into account relevant regulatory requirements for effective submissions and approval of new products, indications, and/or relevant label extensions.
- Model-Based Approaches: You will identify opportunities for the use of model-based approaches for evidence generation in life-cycle management, as appropriate.
- Expertise and Support: You will 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.
- Scientific Expertise: You will develop and maintain contact with internal and external scientific experts.
- Clinical Pharmacology Protocol Design: You will contribute to clinical pharmacology protocol design, data analysis, interpretation, and reporting of clinical PK, PKPD, and population PKPD modelling and simulation.
- Regulatory Document Review: You will review and update the clinical pharmacology components of regulatory documents and responses, such that GSK and ViiV products are approved with optimum labelling.
- Nonclinical Disciplines: You will integrate relevant information from nonclinical disciplines (e.g., biology, formulations, statistics) into CPMS technical activities and drug development strategy.
- Regulatory Guidelines: You will have a working knowledge of relevant country-specific regulatory guidelines (e.g., ANVISA), in addition to FDA, EMA, and ICH guidelines.
- Pediatric Investigation Plans: You will implement 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.
- Best Practices: You will adhere to best practices and learnings from internal and external sources.
We are looking for professionals with the following required skills to achieve our goals:
- PhD and/or MD Degree: You must have a PhD and/or MD degree in clinical pharmacology or a similar discipline.
- Relevant Experience: You must have relevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical company.
- Regulatory Guidelines: You must have experience and understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities.
If you have the following characteristics, it would be a plus:
- Pharmacology and Physiology Knowledge: You must have knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics, and commercialization, such that you can assist in managing these interfaces and promote a strong partnership with Medical Affairs, Clinical Safety, and other relevant business partners.
- Clinical Pharmacology Studies: You must have experience in the design, analysis, interpretation, and reporting of clinical pharmacology studies, including bioequivalence, concentration-QT, organ impairment, and other special populations (e.g., Japanese, older adults).
- Standard and Innovative Clinical Study Protocol Design: You must have a 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.
- Quantitative Clinical Pharmacology: You must have experience in quantitative clinical pharmacology, including population PK modelling, drug-disease modelling, clinical trial simulations, and dosing algorithms.
- Statistical Methodologies: You must have a working knowledge of statistical methodologies, including ANOVA, hypothesis testing, Bayesian inference, nonlinear mixed-effects modelling.
- Excellent Communication Skills: You must have excellent written (scientific and non-technical) communication skills in English.
- Team Player: You must be a team player and function effectively in a matrix team setting.
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London, Greater London, United Kingdom VONQ Full timeAbout the RoleWe are seeking an experienced Clinical Pharmacology Lifecycle Management Director to join our team at VONQ. As a key member of our organization, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio.Main ResponsibilitiesIntegrate clinical pharmacology and...
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London, Greater London, United Kingdom VONQ Full timeAbout the RoleWe are seeking an experienced Clinical Pharmacology Lifecycle Management Director to join our team at VONQ. As a key member of our organization, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio.Main ResponsibilitiesIntegrate clinical pharmacology and...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Pharmacology Lifecycle Management Director to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Pharmacology Lifecycle Management Director to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology Lifecycle Management ExpertWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management Expert to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology Lifecycle Management ExpertWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management Expert to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for our...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionA unique opportunity has arisen within our Clinical Pharmacology Lifecycle Management team for an experienced professional to provide clinical pharmacology, therapeutic, and regulatory support for our portfolio.You will be responsible for ensuring the optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling &...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionA unique opportunity has arisen within our Clinical Pharmacology Lifecycle Management team for an experienced professional to provide clinical pharmacology, therapeutic, and regulatory support for our portfolio.You will be responsible for ensuring the optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling &...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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London, Greater London, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management professional to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will play a critical role in providing clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Accountabilities:Integration of...
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