Director of Clinical Pharmacology and Pharmacometrics, Anti-Viral
- Research Triangle Park, NC
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence
Posted Date: Aug 21 2020
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.
- A doctorate (PhD, PharmD or MD) relevant to Quantitative Clinical Pharmacology in pharmaceutical research and development.
- Substantial experience in clinical pharmacokinetics, modelling/simulation and drug development to solve practical problems in pharmaceutical industry.
- Proven skills in pharmacokinetic-pharmacodynamic and model based meta-analysis; verifiable proficiency in pharmacometric tools such as NONMEM, Monolix, R or SAS.
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of viral diseases.
If you have the following characteristics, it would be a plus:
- Small molecules and biologics experience in the viral Disease area.
- 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.
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.
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.
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