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Reference #: 389362 Site Name: UK - Hertfordshire - Stevenage, Cambridge MA, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: Mar 4 2024 Associate Director/Director, Quantitative Systems Pharmacology

The Department of Clinical Pharmacology Modelling and Simulation (CPMS) at GSK is recruiting for an Associate Director/or Director level Quantitative Systems Pharmacologist, with a robust background in Respiratory & Immunology.

Locations include Stevenage, UK; Collegeville, PA, USA; Durham, NC, USA; Cambridge, MA, USA. Working at other GSK sites in Europe or working remotely may be considered for the right candidate.

This position represents an excellent opportunity for professionals with a PhD, MD, PharmD or equivalent doctoral background, who are experienced mathematical modellers, where one will use Quantitative Systems Pharmacology, mathematical modelling, and computational skills together with Pharmacometrics to advance the vision and mission of GSK's rapidly expanding Respiratory & Immunology portfolio. Sought after experiences for this position include building and integrating mechanistic mathematical models and disease platforms with advanced analytical techniques (such as machine learning) to enhance the robustness and quality of decision-making from exploratory research, clinical development, registration, and life cycle management.

At GSK we develop therapies of various modalities for a broad range of indications. CPMS responsibilities and accountabilities commence at candidate selection stage with preparations of first time in human trials, and continue through to filing, registration, and market expansion. As a member of a global department with diverse expertise, you will enjoy a highly supportive environment for scientific innovation, business impact and professional growth. CPMS work directly supports GSK mission to help our patients feel better and live longer by getting ahead of disease together.

Key Responsibilities include, but are not limited to:

The key responsibilities and accountabilities comprise of both modelling/simulation activities and clinical pharmacology leadership and include:

Build, develop, guide development and/or utilize mechanistic models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalities; conduct simulations to generate virtual patients to optimize trial design; conduct meta-analyses as appropriate to generate knowledge through data re-use.

Develop and/or utilizestate-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction.

Contribute to clinical program design and dosing regimen selection, trial protocols, analysis plans, study reports and regulatory submissions as appropriate.

Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, statisticians and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms.

Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline.

Present strategy and defend outcome of model-based approaches to internal governance boards and regulatory agencies.

Promote Model-Informed Drug Discovery and Development (MID3) through external presentations at international conferences and publications in peer-reviewed scientific journals.

Why you? Qualifications:

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

PhD, MD, or PharmD with experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development.

Substantial experience in utilizing mechanistic mathematical modelling and simulation (QSP, PKPD, etc.) to apply to questions in drug discovery and development to solve practical problems in industry and/or academia.

Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.

Knowledge of or ability to quickly learn the mechanism, endpoints, progression, prevention, and treatments of Infectious, Immunological or Inflammatory Diseases.

Experience working with key stakeholders in a cross functional environment.

Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.

Strong track record of implementation of MIDD approaches to accelerate patient access to novel therapies.

Strong publication record in peer-reviewed journals.

Preferred Skills & Qualifications:

If you have the following characteristics, it would be a plus:

A doctorate that is relevant to Quantitative Systems Pharmacology (e.g., Mathematics, Engineering, Physics, Systems Biology, Mathematical Modelling, etc.).

Passion for Quantitative Clinical Pharmacology and desire to innovate for better outcome.

Prior experience in clinical QSP modelling in Respiratory & Immunologyin an industry setting.

Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.

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. The information that you have provided in your cover letter and CV will be used to assess your application.

Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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).

We believe in an agile working culture for all our roles. If flexibility i