Manager, Clinical Pharmacology Modeling and Simulation
- Collegeville, PA
Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, Upper Providence
Posted Date: Aug 21 2020
The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist at the Manager level. CPMS is a science driven group delivering clinical pharmacology and modelling simulation excellence to development programs. The right candidate will have the opportunity to work on both small molecules and biologics in the antiviral disease area although there may be opportunities in the future to contribute to programs in other therapy areas.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. These include some of the following:
- Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program and robust registration packages
- Play a central role in predicting human dose range, characterizing 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 modeling 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:
- PhD, PharmD or MD
- Experience using modelling tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and/or MATLAB
- Experience working with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
If you have the following characteristics, it would be a plus:
- Understanding of pharmacokinetic and pharmacodynamic principles
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of viral diseases and other relevant therapy areas
- Experience or working in matrix across departmental lines
- Strong communication skills
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- 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.
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