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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 lifecycle 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 lifecycle 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 lifecycle 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.
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. 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).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
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.
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