Director Quantitative Clinical Pharmacology, Oncology
- Research Triangle Park, NC
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: May 29 2020
The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist with strong clinical pharmacology and pharmacometric skills at the Director level. CPMS is a science driven group using quantitative clinical pharmacology approaches, as part of the model-informed drug discovery and development (MID3) paradigm, to evolve understanding of compound behavior and optimize dose across the development continuum, delivering a competitive label.
A successful candidate will have the opportunity to bring clinical pharmacology and modelling & simulation excellence to development programs, and work on biologics, novel modalities, small molecules, and cell therapy in the oncology area.
This position can be based at GSK US at the Collegeville, PA or Waltham, MA locations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- CPMS responsibilities cover the life cycle of drug development, commencing engagement post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to end of 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.
- Guide the development of mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; ensure the conduct of meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
- Play a central role in predicting human dose range, by the characterising dose-response relationship and justifying dose recommendations for special populations
- Present the CPMS strategy and be able to 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.
- Advocate for the use of model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation
- Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages
- Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
- Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
- Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientists
We are looking for professionals with these required skills to achieve our goals:
- Advanced training with a degree such as PhD, PharmD and MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development
- Substantial experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacometrics approaches, and model-informed drug discovery & development
- A strong quantitative clinical pharmacologist who can articulate and advocate for the use of modeling and simulation approaches to address drug development issues and questions. Proficiency with one or more pharmacometric tools such as NONMEM, Monolix, WINNONLIN and R would be expected
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- 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 prioritizing multiple tasks.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.
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.
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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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