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 careers@clickdx.com with the subject "Clinical Affairs Sr. Manager/Director”.

A survey of UK academics found that women tended to have higher teaching loads than men, according to Nature News.

A study appearing in PNAS finds that the mean age of the US scientific workforce is increasing.

At Science Careers, Princeton University's Julian West advises new researchers to read widely.

At Science Careers, a researcher describes how her rejuvenated postdoc science policy committee is promoting science.