Clinical Pharmacology Lifecycle Management Expert

4 weeks ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Main Responsibilities

We 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 life-cycle management of medicinal products.

Key Accountabilities
  • 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
  • Contribution 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
  • 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 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
  • Adherence to best practices and learnings from internal and external sources
Requirements

We are looking for professionals with the following 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.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

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