Manager, Clinical Pharmacology

Your Responsibilities:
The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist. 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 HIV / Infectious Disease area although there may be opportunities in the future to contribute to programs in other therapy areas.

Responsibilities include:
• Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages
• Play a central role in predicting human dose range, characterising 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 modelling 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

Why You?

Basic qualifications:
• 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
• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology and other relevant therapy areas
• Understanding of pharmacokinetic and pharmacodynamic principles and commonly applied models; working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and MATLAB
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs

Preferred qualifications:
• Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
• Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies
• 2 years post-graduation experience in a fellowship or industry environment
• Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
• Preferred requirement is demonstrated experience in drug development of novel oncology therapeutics

GlaxoSmithKline provides a supportive environment for scientists who are aspired to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.

Why GSK?:
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.

We want to help people do more, feel better, live longer

We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.

As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.


Contact information:
You may apply for this position online by selecting the Apply now button.
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