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Director of Clinical Pharmacology and Pharmacometrics, Anti-Viral

Collegeville, Pennsylvania; Research Triangle Park, North Carolina; Philadelphia, Pennsylvania
Closing date
Jul 27, 2021

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Life Sciences, Pharmacology
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Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: May 14 2021 We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our Collegeville, PA-based team supporting antiviral disease area as part of the global department of Clinical Pharmacology Modelling & Simulation. As the Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will contribute to or lead a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. You'll have the opportunity to work on both small molecules and biologics in the antiviral Disease area. 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. Provide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds. Play a central role in predicting human dose range, characterising exposure-response relationship and justifying dose recommendations for special populations. Develop mathematical models to understand 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. Present strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies. Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy. Promote model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation. Why you? Basic Qualifications: A doctorate (PhD, PharmD or MD) relevant to Quantitative Clinical Pharmacology in pharmaceutical research and development. Experience in clinical pharmacokinetics, modelling/simulation and drug development to solve practical problems in pharmaceutical industry. Experience in pharmacokinetic-pharmacodynamic and model based meta-analysis; experience with pharmacometric tools such as NONMEM, Monolix, R or SAS. Experience with mechanism, endpoints, progression and treatments of viral diseases. Preferred Qualifications: If you have the following characteristics, it would be a plus: Small molecules and biologics experience in the viral Disease area. Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design. Demonstrated experience in drug development of antiviral therapeutics. Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritising multiple tasks. Why GSK? Our values and expectations are 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk Managing individual and team change.performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Salary range 159682.70 - 187862 CPMS_US_UK *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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