Scientific Director, Clinical Pharmacology-Location–Home Based
- Provide global development science and strategic expertise to projects within a specific TA. Provide regulatory expertise for clinical pharmacology registration within a specific TA
- Have thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TA
- Provide creative clinical pharmacology input for profiling of compounds to enable successful commercial differentiation
- As a global clinical pharmacology lead for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility for registration
Essential Job Responsibilities:
- Provides disease area expertise and opportunities for scientific contributions to the team
- Oversees interpretation of complex data, provides leadership in model based drug development, introduces “state-of-art” translation medicine strategies, platforms and methodologies
- Defines and maintains a leading overall exploratory development and clinical pharmacology strategy.
- Responsible for providing scientific oversight for preparation of various sections of regulatory documents, such as IB, IMPD and CTD.
- Provides appropriate clinical pharmacology scientific input on licensing opportunities.
- Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infra- structural projects and/or departmental activities
- Contributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of clinical pharmacology
- Be the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.
- This requires leading a cross functional team of 15 — 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.
- Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
- As a clinical pharmacology lead, provide the scientific lead for a cross-functional team of 15 – 25 people
- Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
- Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
- Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
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