Manager, Quantitative Clinical Pharmacology, Oncology
- Waltham, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: May 29 2020
Are you energized by leveraging your broad scientific expertise to accelerate the development of medicines? If so, this Clinical Pharmacology Manager role could be an exciting opportunity to explore.
As the Manager of Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You'll have the opportunity to work on antibodies, novel modalities, small molecules and cell therapy approaches in the Oncology Therapeutic area. GlaxoSmithKline provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.
CPMS responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.
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...
- Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program, robust registration package and support life cycle management of as asset
- 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, characterizing 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 the CPMS 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
- Advocate for the use model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation.
- 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
- 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
- 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
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 MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development
- 2 years post-graduation experience in a fellowship or industry environment
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology 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
- Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
- Sound judgement, analytical mindset and problem-solving skills
- Ability to effectively multi-task and deliver results on time
If you have the following characteristics, it would be a plus:
- Substantial experience in clinical pharmacokinetics, modelling & simulation and drug development
- Experience in designing, analyzing 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 expertise in a specific technical area, and/or oncology disease area
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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