Manager, Clinical Pharmacology Modeling and Simulation

The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GSK is recruiting for a Manager, Clinical Pharmacology Modeling and Simulation.  CPMS is a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. A successful candidate will have the opportunity to work on both small molecules and biologics in the infectious diseases area although there may be opportunities in the future to contribute to programs in other therapy areas.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program and robust registration packages

• Play a central role in predicting human dose range, characterizing dose-response relationship and justifying dose recommendations for special populations

• Develop mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance

• Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics

• Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate

• Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages

• Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators

• Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, physicians and drug metabolism scientists

• Learn and apply emerging modeling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application

• Promote clinical pharmacology strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences

Minimum Qualifications:

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

• Advanced training with a degree such as PhD, PharmD and MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development

• Experience working with the mechanism, endpoints, progression and treatments of diseases in Oncology and other relevant therapy areas

• Experience working with pharmacokinetic and pharmacodynamic principles and commonly applied models for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and MATLAB

• Experience with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs 

• 1 or more years post-graduation experience in a Pharmaceutical fellowship or industry environment

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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 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, it’s also about making GSK a place where people can thrive. We wan