Director Clinical Pharmacology Lifecycle Management

A fantastic opportunity is available within GSKs Clinical Pharmacology Lifecycle Management team for an experienced individual who will provide clinical pharmacology therapeutic and regulatory support for GSK portfolio.

You will ensure optimal application of clinical pharmacokinetic (PK) pharmacodynamic (PD) and modelling & simulation (M&S) principles towards efficient evidence generation for the registration and lifecycle management of medicinal products.

Main accountabilities include:

Integration of clinical pharmacology and PKPD principles into clinical development and lifecycle management plans and product strategies
Support accelerated regulatory filing activities across multiple regions/markets with focus on countryspecific requirements.

Preparation authoring and review of 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.
Identification of opportunities for the use of modelbased 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
With appropriate guidance contribute to clinical pharmacology protocol design data analysis interpretation and reporting of clinical PK PKPD and population PKPD modelling and simulation
Review and update of the clinical pharmacology components of regulatory documents and responses such that 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
Understanding of relevant countryspecific regulatory guidelines (e.g.. ANVISA) in addition to FDA EMA and ICH guidelines
Implementation of 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

Why you

Basic Qualifications:

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

• PhD and/or MD degree in clinical pharmacology or 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 he/she 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 concentrationQT 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 realworld evidence

• Experience in quantitative clinical pharmacology including population PK modelling drugdisease modelling clinical trial simulations and dosing algorithms

• Understanding of statistical methodologies: ANOVA hypothesis testing Bayesian inference nonlinear mixedeffects modelling

• Excellent written (scientific and nontechnical) 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 a cover letter to describe how you meet the competencies for this role.

*LIGSK

Why GSK

Uniting science technology and talent to get ahead of disease together.

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 its 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 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**US only).

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