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Director, Quantitative Clinical Pharmacology at GlaxoSmithKline

Posted in Health Care 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Philadelphia, Pennsylvania

Job Description:

Position Title: Director, Quantitative Clinical Pharmacology

Working Location: Pennsylvania

Employment Status: Full time

Required Experience: 7 years

Required Education: Phd/Doctorate

Travel Required: 0%

Job Description:

The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist at the Director level. 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 oncology area although there may be opportunities in the future to contribute to programs in other therapy areas. Position can be based at GSK US or UK sites, with a preference for the Collegeville, PA, US site.

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 model-informed drug discovery & development (MID3) strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences

Essential Skills:

• Requires advanced training with a degree such as PhD, or PharmD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development. Qualified physicians with relevant experience will also be considered

• Requires 7--10 yrs experience in clinical pharmacokinetics, modelling & simulation and drug development

We are an Equal Opportunity Employer and do not discriminate against

any employee or applicant for employment because of race, color, sex,

age, national origin, religion, sexual orientation, gender identity,

status as a veteran, and basis of disability or any other federal,

state or local protected class.