Manager/Associate Director Clinical Pharmacology Lifecycle Management

vor 16 Stunden

Zug, Schweiz GSK Vollzeit
Site Name: UK – London – New Oxford Street, Home Worker - USA, Zug House
Posted Date: Dec 3 2024

About Us: We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Are you energized by a role that requires strategic thinking and extensive internal and external engagement? If so, this Manager/Associate Director Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore.

The Manager/Associate Director Clinical Pharmacology Lifecycle Management will provide clinical pharmacology, therapeutic and regulatory support for GSK’s product portfolio worldwide. The individual will also contribute to the evidence generation plans for new and existing medicinal products.

In this role you will:

  • Ensure integration of clinical pharmacology and PKPD principles into clinical development, regulatory approval and life-cycle management of GSK products.

  • Support accelerated regulatory filing activities across multiple regions/markets, with focus on country-specific requirements.

  • Lead the preparation, authoring and review of CTD modules taking into account country-specific regulatory requirements for effective submissions and approval of new products, indications and/or relevant label extensions.

  • Develop and 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.

  • With appropriate guidance contribute to the design, data analysis, interpretation and reporting of clinical pharmacology studies.

  • With appropriate guidance implement, analyse and report PK, PKPD, and drug-disease modelling and simulation studies.

Basic Qualifications & Skills:

  • PhD and/or MD degree in clinical pharmacology or other relevant discipline (e.g. Pharmaceutical Sciences, Bioengineering, Pharmacy).

  • Relevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical company.

  • Understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities.

  • Project management experience.

Preferred Qualifications & Skills:

  • Knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics and commercialization.

  • Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies.

  • Working knowledge in standard and innovative clinical study protocol design across different phases of development and life-cycle management.

  • 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.

  • Proven performance in a matrix team environment.

Closing Date for Applications: Tuesday 17th December 2024 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.

Why GSK? GSK is a global biopharma company with a special purpose – to unite 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).

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, colour, 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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