Manager/Associate Director Clinical Pharmacology Lifecycle Management

Site Name: UK – London – New Oxford Street, Baar Onyx, Home Worker – GBR, Upper Providence, Wavre

Posted Date: Feb 19 2025

415150 Manager/Associate Director, Clinical Pharmacology (Lifecycle Management) – 2 Year Fixed Term Contract/Secondment

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.

Please note that this role will initially be a 2-year Fixed Term Contract (with most employee benefits) or Secondment with the opportunity to extend or potentially convert to regular status depending on business need. Depending on level of candidate experience, we will be able to consider this position at either the G6 or G5 level.

In this role you will:

1. Ensure integration of clinical pharmacology and PKPD principles into clinical development, regulatory approval and life-cycle management of GSK products.
2. Support accelerated regulatory filing activities across multiple regions/markets, with focus on country-specific requirements.
3. 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.
4. 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.
5. With appropriate guidance contribute to the design, data analysis, interpretation and reporting of clinical pharmacology studies.
6. With appropriate guidance implement, analyse and report PK, PKPD, and drug-disease modelling and simulation studies.

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

1. PhD and/or MD degree in clinical pharmacology or other relevant discipline (e.g. Pharmaceutical Sciences, Bioengineering, Pharmacy).
2. Relevant experience in the application of clinical pharmacology, modelling and simulation methodologies to drug development and lifecycle management, ideally gained within a pharmaceutical company.
3. Understanding of regulatory guidelines, ideally demonstrated experience interacting with regulatory authorities.
4. Project management experience.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

1. 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.
2. 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).
3. 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.
4. Experience in quantitative clinical pharmacology, including population PK modelling, drug-disease modelling, clinical trial simulations, and dosing algorithms.
5. Understanding of statistical methodologies: hypothesis testing, Bayesian inference, nonlinear mixed-effects modelling.
6. Proven performance in a matrix team environment.

Closing Date for Applications – March 10th, 2025 (COB)

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D.

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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