Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing CPED (Clinical Pharmacology & Exploratory Development) Science Director opportunity in Northbrook, IL.
Purpose & Scope:
- 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 Astellas compounds to enable successful commercial differentiation
- As a GCPL for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility of CPED for registration
Essential Job Responsibilities:
- Provides disease area expertise and opportunities for CPED-science contributions to Core Team
- Oversees interpretation of complex data, provides leadership to Core Team in model based drug development, introduces "state-of-art" translation medicine strategies, platforms and methodologies to Core Team
- Defines and maintains a leading overall exploratory development and clinical pharmacology strategy that will ensure the success of Astellas. Where appropriate, prioritize studies within CPED.
- Contributes to the definition of world class, leading exploratory development, clinical pharmacology that will ensure success of Astellas projects.
- 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 CPED
- Displays leadership attributes that lead to the improvement of CPED processes and level of science
- 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 GCPL, provide the scientific lead for a cross-functional team of 15 - 25 people
- Supervise 1-3 junior CPED scientists.
- 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.
- Reports to Senior Director or Executive Director, CPED Science
- May have direct reporting CPED scientists who are responsible for providing contributions to individual projects
- May have functional management of scientists
- The total budget of the clinical pharmacology science section will be around 4M $USD, annually
- Preferred MD/ PhD /PharmD
- Requires at least 7years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a good understanding of Drug Discovery and Development.
- Thorough understanding of clinical pharmacology discipline and how it is applied throughout all phases of drug development
- Thorough understanding of regulatory strategies and guidelines
- Extensive experience in regulatory filings, eg., IND, IMPD, NDA, etc.
- Extensive experience in regulatory interactions with regulatory authorities worldwide
- Strong leadership skills