Director Clinical Pharmacology Life Cycle Management, Open to flexible working - homeworking
2 years fixed terms
Or home based with travel
Are you energized by a leadership role that requires strategic thinking and extensive internal and external engagement? If so, this Senior Director Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore.
The Senior Director Clinical Pharmacology Lifecycle Management will provide advanced clinical pharmacology, therapeutic and regulatory support for GlaxoSmithKline marketed products worldwide. The individual will also provide strategic support for evidence generation in Classic and Established Products (CEP), ensuring pro-active life-cycle management of the portfolio
This exciting role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:
- Serving as point of contact for response to regulatory questions (RTQs) involving clinical pharmacology issues
- Writing and reviewing clinical pharmacology study reports and regulatory documents.
- Preparation, implementation and/or review of Global Data Sheet and label updates, with special focus on dosing recommendations, special populations (paediatrics, elderly, organ impairment, ethnic groups), drug-drug interactions (DDIs), pregnancy and lactation.
- Maintaining an advanced knowledge of therapeutic guidelines, clinical pharmacology, drug metabolism and clinical safety (e.g. DDIs), ensuring best practice and expert support to life-cycle management activities.
- Explore the impact of evolving technologies, including evidence synthesis by modelling and simulation using internal and external data sources to promote pro-active clinical pharmacology life-cycle management.
- Developing and maintaining contact with internal and external scientific experts
- Preparation, implementation, and/or review of model-informed evidence generation for CEP and specialty medicines.
- Ensuring the integration of MIDD concepts into Clinical Pharmacology Modeling and Simulation plans and overall project and clinical development strategies
- Thorough understanding and ability to assess requirements and apply appropriate FDA, EMA, SWISSMEDIC, China FDA, PMDA, TGA, ANVISA and ICH guidelines when new evidence is required for marketed products.
- Approval of design, analysis, interpretation and reporting of clinical PK, PK/PD, and population PK/PD reports.
- Writing and reviewing the clinical pharmacology and clinical overview modules of regulatory filings and responses such that GSK and ViiV products are efficiently approved with optimum labelling
We are looking for candidates with the following qualifications:
- PhD or MD with prior experience in clinical pharmacology and and late stage clinical (Phase IIb/III and IV) drug development,
- Working knowledge of modelling & simulation methods and concepts
- Good understanding of regulatory processes and procedures
- Proven leadership and performance in a matrix team environment
- Proficiency in English and excellent writing and communication skills.
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