Description

The Department of Clinical Pharmacology & Pharmacometrics, Systems and Tools at GSK is recruiting for an Associate Director level Quantitative Systems Pharmacologist, with a robust background in HIV and Vaccines. 

Preferred site locations: Stevenage, UK; Collegeville, PA, USA; Durham, NC, USA; Cambridge, MA, USA.

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/ViiV's rapidly expanding HIV & Vaccines portfolio. Sought after experiences for this position include building and integrating mechanistic mathematical models and disease platforms with advanced analytical techniques (such as in-silico trial frameworks and scientific machine learning) to enhance the robustness and quality of decision-making from exploratory research, translation, clinical development, registration, and life cycle management.

At GSK we develop therapies of various modalities for a broad range of indications. Our 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. Our 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 for in-silico trials to optimize clinical trial design; conduct meta-analyses as appropriate to generate knowledge through data re-use.

• Develop and/or utilize state-of-the-art mathematical and clinical pharmacology 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, translational and disease-area strategies, analysis plans, study reports, regulatory submissions, and due diligence for business development as appropriate.

• Work in close collaboration with biologists/virologists, 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 required.

• 5+ years' experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development.

• 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.

• Experience with mechanisms, endpoints, progression, prevention, and treatments for Vaccines and Infectious Diseases (with a focus on HIV).

• Experience with implementation of model-informed drug development approaches to improve clinical trial success and accelerate patient access to novel therapies.

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.).

• Consistently achieved on-time delivery rate for project milestones by effectively collaborating with a multi-discipline team and utilizing clear communication strategies with key stakeholders in a cross functional environment.

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

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

• Prior experience in clinical QSP, popPK/PD, and virus dynamics modelling as well as virtual patients and in silico trials within infectious diseases (HIV in particular) and Vaccines in an industry setting.

• Demonstrated experience with relevant modalities (small molecule antivirals, monoclonal broadly neutralizing antibodies, bispecific antibodies, mRNA vaccines, adjuvanted protein vaccines, immune-activating agents) would be a plus.

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

• Strong publication record in peer-reviewed journals.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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