Controller/Director of Accounting & Finance

Click Diagnostics is an early stage biotech startup that is looking to hire a Controller/ Director of Accounting & Finance. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Chief Executive Officer.

Position includes, but not limited to:

  • Leadership of accounting and finance functions.  Prepare the company for IPO readiness.
  • Company-wide accounting activities and month-end closing process, in accordance with US GAAP and grant, regulatory requirements
  • System selection and implementation, including ERP, budgeting, stock options, document control, reporting, etc.
  • Direct the annual budgeting and forecasting process
  • Preparation of financial and accounting reports for management, board and investors.
  • Development and maintenance of policies to ensure accurate accounting, financial reporting and reliable internal controls
  • Development, implementation and maintenance of inventory and cost accounting systems and procedures.
  • Manage relationship with the Company’s independent auditors to ensure that annual audits are completed in a timely and efficient manner.
  • Accurate and timely completion of all tax and informational filings.  Coordinate the preparation of corporate and state income tax returns with 3rd party tax preparer.
  • Manage banking relationships - prepare compliance documentation for loan covenants
  • Work closely with CEO on financing activities, financial strategy, and strategic relationships.
  • Support grant application processes
  • Perform special projects and analyses to assist management

Skills, Experience, Education

  • Bachelor’s degree in Accounting/Finance (MBA a plus)
  • CPA preferred
  • 10+ years of accounting and finance experience with strong knowledge of all areas of accounting, cost management, Financial Planning & Analysis, and business decision support.
  • Strong communication, collaboration, presentation and interpersonal skills – ability to operate effectively at all levels of the organization, investors and third-party partner relationships.
  • Proactive approach with high sense of urgency
  • Highly advanced knowledge of Excel & financial modelling preferred
  • Experience with ERP Implementation is an advantage - in particular, with inventory management
  • Life Science experience a plus.
  • Human resources experience a plus.

Compensation

  • Salary, bonus, full benefits, company stock options
  • Title is dependent on education and experience

Contact

Please e-mail your resume to careers@clickdx.com with the subject "Controller/Director of Accounting & Finance”.

 

Clinical Affairs Sr. Manager/Director

Click Diagnostics is an early stage biotech startup that is looking to hire a Clinical Affairs Sr. Manager/Director to its Quality and Regulatory team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports directly 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

Skills, Experience, Education

  • 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

Compensation

  • Salary, bonus, full benefits, company stock options

Contact
Please e-mail your resume to careers@clickdx.com with the subject "Clinical Affairs Sr. Manager/Director”.