Clinical Pharmacology Manager
2 weeks ago
Job Summary
We are seeking a highly skilled Clinical Pharmacology Manager to join our team at GlaxoSmithKline. As a key member of our organization, you will be responsible for providing clinical pharmacology, therapeutic, and regulatory support for our product portfolio worldwide.
Key Responsibilities
- Ensure the integration of clinical pharmacology and pharmacokinetic/pharmacodynamic (PKPD) principles into clinical development, regulatory approval, and life-cycle management of our products.
- Support accelerated regulatory filing activities across multiple regions and markets, with a focus on country-specific requirements.
- Lead the preparation, authoring, and review of Common Technical Document (CTD) modules, taking into account country-specific regulatory requirements for effective submissions and approval of new products, indications, and/or relevant label extensions.
- Identify opportunities for the use of model-based approaches for evidence generation in life-cycle management, as appropriate.
- Develop and maintain a strong working knowledge of pharmacology, physiology, clinical pharmacology, therapeutics, and statistics, ensuring adequate expertise and support is provided to business partners and project teams.
- Contribute to the design, data analysis, interpretation, and reporting of clinical pharmacology studies, with appropriate guidance.
- Implement, analyze, and report PK, PKPD, and drug-disease modeling and simulation studies, with appropriate guidance.
- Review and update the clinical pharmacology components of regulatory documents and responses, ensuring GSK and ViiV products are approved with optimum labeling.
- Integrate relevant information from nonclinical disciplines (e.g., biology, formulations, statistics) into clinical pharmacology and medical affairs activities and drug development strategy.
- Contribute to the implementation of pediatric investigation plans (PIPs) and pediatric study plans (PSPs), enabling effective use of extrapolation approaches across global programs.
Requirements
- 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 life-cycle management, ideally gained within a pharmaceutical company.
- Understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities.
Preferred Qualifications
- Knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics, and commercialization, enabling the management of these interfaces and promotion of 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, drug-drug interaction, 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.
- Proven performance in a matrix team environment.
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