The Clinical Trials / Regulatory Manager will be broadly responsible for overseeing the translation of biomarkers in development to diagnostic assays for clinical use at the bedside.  This will entail helping to define the strategy around the appropriate application of the biomarker and the targeted market segment.  A major portion of the time will be in developing the overall clinical trials strategy and managing these trials to ensure results are obtained for eventual FDA submission.  Also, a main goal will be to lead the FDA submission process and to interact with the FDA to achieve clearance for the intended use.  Additional responsibilities will include providing general regulatory guidance for the Biomarkers business in the US and Canada.  The successful candidate will be part of the Biomarkers US management team and will work closely with the Director of Commercial Operations, the Marketing Manager, and the Clinical Operations Manager, as well as the key functional leads in Hennigsdorf, Germany.

Primary Responsibilities:

• Assisting with the development of the overall clinical trials strategy

• Implementing and executing pre-market studies (clinical and analytical) within the US to attain FDA approval/clearance for innovative in-vitro diagnostics (IVD)

• Planning, implementation and management of an overall study

• Developing, maintaining and tracking project plans, budgets and resources

• Developing/adopting policies and procedures and driving improvements in the conduct of clinical trials

• Selecting and negotiating contracts coordinating and managing external service providers

• Interacting with FDA and other regulatory bodies in support of US but also global submission to negotiate product intended use/indication for use claim establishing requirements for clinical studies

• Authoring clinical protocols and supporting several study documentation

• Providing clinical and regulatory support and expertise for several internal departments and for commercial launch

Minimum Requirements/Experience:

• BA/MS or Diploma in a life/health science related field or nurse/technician with experience in clinical studies

• At least 5-7 years of practical experience

• Experience in all aspects of developing and executing clinical studies

• Experience in developing clinical protocols Informed Consent Forms and CRFs is a must

• Broad clinical trial experience with IVDs

• Several years of clinical project management experience in a company or CRO

• Specific knowledge of US-Regulatory requirements (European is a plus)

• Capable of managing multiple projects simultaneously

• High organizational skills and ability to work in a team environment

• Background in statistics, multivariate statistics and/or experimental design is a plus

• Excellent oral and written communication skills and ability to communicate to technical and medical audience

• English required, knowledge of German preferred

• Experience in a global business environment

• Willing to travel up to 40%, domestic and international