Director, Clinical Pharmacology

GlaxoSmithKline ,
Stevenage, Hertfordshire
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Job Description

A fantastic opportunity is available within the department of Clinical Pharmacology Modelling and Simulation (CPMS) for a 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 immuno-inflammation area although there may be opportunities in the future to contribute to programs in other therapy areas. Main accountabilities include: * Contribute, as a member of a multi-disciplinary team, to the design of 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 Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Advanced training with a degree such as PhD, PharmD and/or MD in clinical pharmacology or similar discipline * Substantial experience in clinical pharmacokinetics, modelling & simulation and drug development * Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in immune-inflammation 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 * Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing * Sound judgement, analytical mindset and problem-solving skills Preferred Qualifications: If you have the following characteristics, it would be a plus: * Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate * Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs * Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies * Demonstrated experience in drug development of novel therapeutics Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. 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 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

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