Astellas Pharma CPED Science Manager in Northbrook, Illinois
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 a CPED Science Manager opportunity in Northbrook, IL.
Purpose & Scope:
Provide scientific support to individual projects/studies within a TA
Essential Job Responsibilities:
- Provides recommendations on scientific issues on clinical studies and planning
- Provide scientific input into the design of clinical pharmacology studies and development of CSR
- Provide clinical, (medical) scientific recommendations to Translational Science Plans
- Be the CPED scientist on the Extended Team and, on occasion, represent CPED on Core
- Project Teams, with close supervision
- Provide supporting information to be used in Safe First Dose document to guarantee the safety of first dosing to man.
- Responsible for having scientific input into the various sections of regulatory documents, such as IB, IMPD and CTD
- Perform exploratory analyses and result summaries that would be used for internal decision- making purposes and presentations
- Be involved in the design of at least 2-3 Exploratory Development or Clinical Pharmacology strategies per year.
- Contribute to on average 3-5 Translational Science Plans on novel projects.
- Be involved in the design of at least 2-3 study protocols per year
- Provide (medical)/scientific contributions to 1-2 Safe First Dosing documents for compounds proposed to be entered first to humans.
- Contribute to on average at least 2-4 IB/IMPD/IND regulatory documentations.
- The position has no direct budget responsibility
This position reports to either Sr. Director, or Executive Director, Global Head Clinical
Pharmacology and Exploratory Development. This position has no direct reports.
- Preferred MD/ PhD /PharmD or MS with relevant experience
- The Manager position requires at least 1 year post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a general understanding of Drug Discovery and Development. In addition, the individual should have the following experiences.
- Working knowledge of Clinical Pharmacology discipline and its methods and approaches
- Good written and communication.
- Strong, critical analytical mind
- Operate with under close supervision.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical Pharmacology and Exploratory Development (CPED)