Current jobs related to Clinical Pharmacology Lifecycle Management Expert - London, Greater London - VONQ
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob OverviewGSK is seeking a highly skilled Clinical Pharmacology Lifecycle Management Expert to join our team. As a key member of our Clinical Pharmacology Lifecycle Management team, you will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.Your main responsibilities will include:Integration of clinical pharmacology and...
-
London, Greater London, United Kingdom GSK Full timeJob Opportunity in Clinical Pharmacology Lifecycle ManagementAt GSK, we are seeking an experienced professional to join our Clinical Pharmacology Lifecycle Management team. The successful candidate will provide clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal products.Main Responsibilities:• Integrate clinical...
-
Clinical Pharmacology Expert
1 month ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology ExpertWe are seeking a highly skilled Clinical Pharmacology 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 portfolio of medicinal products.Key...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeMain ResponsibilitiesWe are seeking an experienced professional to provide clinical pharmacology, therapeutic, and regulatory support for our portfolio. The successful candidate will ensure the optimal application of clinical pharmacokinetic, pharmacodynamic, and modelling & simulation principles towards efficient evidence generation for the registration and...
-
Clinical Pharmacology Expert
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology ExpertWe are seeking a highly skilled Clinical Pharmacology 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 portfolio.Key...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeJoin GSK's Clinical Pharmacology Lifecycle Management TeamWe are seeking a highly skilled Clinical Pharmacology Lifecycle Management Expert to join our team at GSK. As a key member of our Clinical Pharmacology Lifecycle Management team, you will provide clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeWe are seeking an experienced Clinical Pharmacology Lifecycle Management Specialist to join our team at GlaxoSmithKline. In this role, you will provide clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal products.Your key responsibilities will include:Integration of clinical pharmacology and PKPD principles into clinical...
-
Clinical Pharmacology Expert
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology ExpertWe are seeking a highly skilled Clinical Pharmacology 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 portfolio.Key Responsibilities:Integrate...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeMain ResponsibilitiesAs a Clinical Pharmacology Lifecycle Management Director at GlaxoSmithKline, you will play a crucial role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal products. Your primary focus will be on ensuring the optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD),...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeMain ResponsibilitiesAs a Clinical Pharmacology Lifecycle Management Director at GlaxoSmithKline, you will play a crucial role in providing clinical pharmacology, therapeutic, and regulatory support for our portfolio of medicinal products. Your primary focus will be on ensuring the optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD),...
-
London, Greater London, United Kingdom GSK Full timeJob DescriptionWe are seeking an experienced Clinical Pharmacology Lifecycle Management Specialist to join our team at GSK. The successful candidate will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio. Main Responsibilities: Integration of clinical pharmacology and PKPD principles into clinical development and life-cycle...
-
London, Greater London, United Kingdom GSK Full timeJob DescriptionAt GSK, we are seeking a highly skilled Clinical Pharmacology Lifecycle Management Specialist to join our team. This role will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio. The successful candidate will ensure optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling &...
-
London, Greater London, United Kingdom GSK Full timeJob DescriptionGSK is seeking an experienced Clinical Pharmacology Lifecycle Management Director to join our team. As a key member of our Clinical Pharmacology Lifecycle Management team, you will provide clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Responsibilities:Integrate clinical pharmacology and...
-
London, Greater London, United Kingdom GSK Full timeJob DescriptionGSK is seeking an experienced Clinical Pharmacology Lifecycle Management Director to join our team. As a key member of our Clinical Pharmacology Lifecycle Management team, you will provide clinical pharmacology, therapeutic, and regulatory support for GSK's portfolio.Main Responsibilities:Integrate clinical pharmacology and...
-
Clinical Pharmacology Specialist
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology SpecialistWe are seeking a highly skilled Clinical Pharmacology Specialist 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.Key...
-
Clinical Pharmacology Specialist
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology SpecialistWe are seeking a highly skilled Clinical Pharmacology Specialist 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.Key...
-
London, Greater London, United Kingdom GSK Full timeJob DescriptionA key opportunity exists within GSK's Clinical Pharmacology Lifecycle Management team for an experienced professional to provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.The successful candidate will ensure optimal application of clinical pharmacokinetic (PK), pharmacodynamic (PD), and modelling & simulation...
-
Clinical Pharmacology Specialist
1 month ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology SpecialistWe are seeking a highly skilled Clinical Pharmacology Specialist 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...
-
Clinical Pharmacology Specialist
1 month ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology SpecialistWe are seeking a highly skilled Clinical Pharmacology Specialist 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...
-
Clinical Pharmacology Specialist
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Clinical Pharmacology SpecialistGSK is seeking a highly skilled Clinical Pharmacology Specialist to join our Clinical Pharmacology Lifecycle Management team. As a key member of the team, you will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.Main Responsibilities:Integration of clinical pharmacology and PKPD...
Clinical Pharmacology Lifecycle Management Expert
2 months ago
We 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 clinical pharmacology and pharmacokinetic/pharmacodynamic principles into clinical development and life-cycle management plans and product strategies.
- Support accelerated regulatory filing activities across multiple regions/markets, with a focus on country-specific requirements.
- Preparation, authoring, and review of CTD modules, 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.
- Contribution to clinical pharmacology protocol design, data analysis, interpretation, and reporting of clinical PK, PKPD, and population PKPD modeling and simulation, with appropriate guidance.
- Review and update of the clinical pharmacology components of regulatory documents and responses, such that GSK and ViiV products are approved with optimum labeling.
- Integration of 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 pediatric investigation plans (PIPs) and pediatric study plans (PSPs), ensuring effective global programs and implications for clinical development plans and strategy for the indication in adults.
- Adherence 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 in clinical pharmacology or a similar discipline.
- Relevant experience in the application of clinical pharmacology, modeling, 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.
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 you 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.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 modeling, drug-disease modeling, clinical trial simulations, and dosing algorithms.
- Understanding of statistical methodologies: ANOVA, hypothesis testing, Bayesian inference, nonlinear mixed-effects modeling.
- 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 and a cover letter to describe how you meet the competencies for this role.
We are an equal opportunities employer and welcome applications from all qualified candidates.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
