Vacancy expired!
Software Guidance & Assistance, Inc., (SGA), is searching for an Clinical Development Lead for a Contract assignment with one of our premier Pharmaceutical Services clients in Indianapolis, IN. Responsibilities :
- Work with other Clinical Development Leaders, Clinical Operations, Regulatory, Quality, Labelling, Lifecycle teams, and R&D to generate Scientific Validity Assessments and Clinical Performance plans and reports according to the IVD-Regulation for both conformity assessment and post-market follow up.
- Support Indication Area Leaders and Clinical Development Leaders in the assessment and definition of Intended Uses (IU), clinical testing purposes of the IVD products, and CDMA deliverables according to the IVD-Regulation.
- Assess clinical evidence and state of the art in medicine related to the IVD products to asses and demonstrate clinical benefit and safety.
- Work and align with Post-Market Surveillance & Vigilance (Global Regulatory & Quality) on post market obligations.
- First work experience within the pharmaceutical, medical device, diagnostics industry, or academic hospital environment, in particular with clinical development
- Fluent in English; additional languages are a plus
- Ability to build and foster multidisciplinary global relationships
- Broad biomedical understanding and interest across multiple disease areas
- Strong analytical skills
- Ability keeping the overview
- Simplifying complex processes and organizing people and activities to achieve results
- Natural science or medical degree (PhD or PharmD) preferred
Vacancy expired!