Clinical Pharmacology Lifecycle Management Expert
3 weeks ago
At 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 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.
• Prepare, author, and review 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.
• Identify opportunities for the use of model-based approaches for evidence generation in life-cycle management, as appropriate.
• Develop and/or 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.
• Develop and maintain contact with internal and external scientific experts.
• Contribute to clinical pharmacology protocol design, data analysis, interpretation, and reporting of clinical PK, PKPD, and population PKPD modelling and simulation, with appropriate guidance.
• Review and update the clinical pharmacology components of regulatory documents and responses, ensuring 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.
• Understand relevant country-specific regulatory guidelines (e.g., ANVISA), in addition to FDA, EMA, and ICH guidelines.
• 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.
• Adhere 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 a 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 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 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 and a cover letter to describe how you meet the competencies for this role.
At GSK, we are committed to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
We are an equal opportunities employer and adhere to affirmative action principles. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. We are committed to diversity and inclusion and welcome applications from all qualified candidates.
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