Clinical Affairs Sr. Manager/Director

Organization
ClickDX
Job Location
San Jose, CA
Job Description

Click Diagnostics is an early stage biotech startup that is looking to hire a Clinical Affairs Senior Manager/Director. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the CEO.

Scope of Position

The Clinical Affairs Sr. Manager/Director is an enthusiastic, self-motivated individual with great communication skills who can support the development and management of the Clinical Affairs program compliant with FDA regulations and ICH guidelines. The Clinical Affairs Sr. Manager/Director is responsible for the design, management and oversight of clinical trials in support of the development of new diagnostic tests. 

  • Design and oversee clinical studies from the planning to execution
  • Collaborate with stakeholders from R&D, QA/RA, and Product to develop clinical strategies
  • Manage resources and timelines associated with all clinical study activities including clinical trial agreements, IRB review, and testing agreements
  • Ensure the appropriate development of all documents including but not limited to: study protocols and reports, informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
  • Ensure maintenance of clinical files according to applicable regulations, guidelines, and corporate policy
  • Direct and oversee CRO and other study related vendors in the execution of clinical studies
  • Develop working relationships with external experts/opinion leaders
  • Up to 25% travel required
Requirements
  • BS in science or engineering required;  MS or PhD preferred
  • Minimum 10 years of Clinical Affairs experience required, preferably in IVD
  • In-depth knowledge of GDA requirements for clinical validation and CLIA waiver
  • In-depth knowledge of FDA, ICH, and GCP requirements
  • Experience in managing women’s health trials preferred
How to Apply

Please e-mail your resume to [email protected] with the subject "Clinical Affairs Sr. Manager/Director”.