Senior Director, Clinical Pharmacology, Open to flexible working
As Senior Director Clinical Pharmacology you will assume responsibility for leading a team of Clinical Pharmacology Modelling and Simulation (CPMS) colleagues to ensure that projects and the R&D pipeline receive optimal clinical pharmacology and pharmacometric support to access North Asian markets.
In particular, you will be expected to play a critical role in driving integration of end-to-end model-informed drug development in conjunction with the global CPMS group. In addition, you will be accountable for defining, coordinating and defending CPMS development strategies for North/East Asian countries at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans for key therapeutic areas (oncology, immunology, respiratory and specialty, global health and ViiV).
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Define and execute a co-ordinated scientific and/or technical strategy (18-24 months planning horizon) and to co-ordinate outputs from several expertise areas to determine strategy.
- The application of appropriate regulatory (FDA, EMA, CDE and PMDA) and ICH guidelines across major markets in the design of clinical studies and drug development strategy.
- Review and write clinical pharmacology components of all regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology contents).
- Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs that relate to clinical pharmacology and pharmacometric aspects.
- Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology contribution to R&D pipeline.
- Inspire CPMS staff, identify talent, provide appropriate coaching to ensure future leadership for the CPMS organization.
- Interact with line and middle management, staff and external contacts on a functional, strategic and tactical level.
- Represent CPMS on various internal advisory boards, company wide initiatives and/or leadership teams
- Promote transparency and communicate R&D achievements through publications in appropriate scientific journals
We are looking for professionals with these required skills to achieve our goals:
- PhD or MD with significant experience in quantitative clinical pharmacology
- Significant experience in different therapeutics areas in clinical pharmacology and pharmacometrics gained within the pharmaceutical industry
- Experience working with senior stakeholders in a cross functional environment
- Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.
- Experience with managing teams and developing staff
If you have the following characteristics, it would be a plus:
- Prior experience with regulatory submissions and regulatory interaction with North East Asian countries
- Working knowledge and excellent understanding of quantitative methods using in clinical pharmacology and drug development
- Excellent (written and oral) communication skills
- Project experience working in a matrix environment
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