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”.

QC Supervisor/Manager

Click Diagnostics is an early stage biotech startup that is looking to hire a QC Supervisor/Manger to its Quality and Regulatory team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Director of Quality and Regulatory.

Scope of Position

The QC Supervisor/Manager is an enthusiastic, self-motivated individual with great communication skills who can support the development and management of the Quality Control laboratory compliant with ISO 13485 and FDA QSR. The QC Supervisor/Manager will demonstrate a high level of individual responsibility and accountability. 

  • Creating, updating, reviewing and developing QC laboratory standard operating procedures and supporting work instructions in compliance with ISO 13485 and FDA QSR
  • Plan, organize, and supervise the daily work schedule to support production
  • Aid in the development and implementation of inspection procedures
  • Write and perform QC method qualification, verification/validation protocols
  • Performs environmental monitoring of utilities and facilities
  • Complete investigations for Out of Specification (OOS), CAPA, deviations, and perform trending
  • Maintain accurate personnel, training, and inspection records
  • Maintain a safe, organized, and clean work environment

Skills, Experience, Education

  • BS in science or engineering required;  Microbiology, Chemistry, or related discipline a plus; MS or PhD preferred
  • Minimum 5 years of laboratory experience; supervisory 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 "QC Supervisor/Manager”.

Senior Quality Engineer

Click Diagnostics is an early stage biotech startup that is looking to hire a Senior Quality Engineer to its Quality and Regulatory team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Director of Quality and Regulatory.

Scope of Position

The Staff Quality Engineer is an enthusiastic, self-motivated individual with great communication skills who can support the development, implementation, and management of the Quality Management Systems to ISO 13485 and FDA QSR. The Staff Quality Engineer will demonstrate a high level of individual responsibility and accountability. 

  • Creating, updating, reviewing and developing Quality Management System standard operating procedures and supporting work instructions per ISO 13485 and FDA QSR
  • Train personnel in requirements of Quality systems, tools, and techniques based on ISO 13485 and FDA QSR
  • Perform root cause data analysis using statistical techniques
  • Write and perform qualification, verification/validation protocols
  • Create and maintain quality metrics as they relate to Quality Systems and Operations
  • Develop and maintain Internal Audit program and schedule
  • Develop and maintain Supplier Quality program including supplier audit 
  • Review and approve Material Review Board and Change Control Board activities

Skills, Experience, Education

  • BS in science or engineering require;  Molecular Biology, Engineering, or related discipline a plus; MS preferred
  • Minimum 3 years of experience in FDA regulated Medical Device industry
  • Hands-on experience with Molecular Biology techniques
  • Professional certification in Quality Auditing, Quality Engineering, and/or Quality Management preferred

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 "Senior Quality Engineer”.

Associate Systems Engineer

Click Diagnostics is an early stage biotech startup that is looking to hire a Associate Systems Engineer to its engineering team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. 

Scope of Position

The Associate Systems Engineer will support the Engineering team in the development of a diagnostic device. The candidate will work closely with a team of engineers and scientists and will have a broad range of responsibilities including, but not limited to:

  • PCBA layout and design. Managing supporting documentation and part procurement.
  • Design and assembly of electromechanical fixtures and development of supporting software (LabVIEW, MATLAB, etc.)
  • Performing biological and engineering experiments.
  • Verification and Validation testing, writing test protocols and generating test reports
  • Generating DCOs, managing BOMs and interfacing with vendors

Skills, Experience, Education

  • BS degree in Electrical Engineering or related discipline required
  • 0-2 years work experience in industry
  • Proficiency working with electronic test and debug equipment including oscilloscopes, DMMs, soldering irons and function generators
  • Strong hands on experience troubleshooting electromechanical systems
  • Preferred skills: experience in PCB design and layout, preferably using Altium Designer, proficiency in C/C++

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 "Associate Systems Engineer (Engineering)”.

Research Associate / Associate Scientist

Click Diagnostics is an early stage Biotech startup that is looking to hire a Research Associate/Associate Scientist to its assay development team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position will support the transition from Research & Development (R&D) to Validation & Verification (V&V) and beyond.

Position includes, but is not limited to.

  • Supporting scientific research with reagent preparation, stability studies, inventory keeping, equipment maintenance/calibration, and general lab maintenance such as cleaning and decontamination
  • Performing verification studies of equipment, reagents, and procedures
  • Creating, testing and executing company Work Instructions for the production and QC of reagents
  • Working with senior scientist to design and conduct scientific research and experiments, such as reagent preparation, DNA extractions, PCR, data analysis, and writing experimental reports
  • Communicating results to the in-house team, other collaborators, or regulatory agencies
  • Working closely with colleagues on experiments and to resolve reagent, material, and instrument issues
  • Following protocols: Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and all pertinent internal and external regulatory guidelines
  • Presenting ongoing work and findings to colleagues and at academic conferences, and summarizing the nature of the research, methodology and results

Skills, Experience, Education

  • BA/BS/MS degree in Biology, Chemistry, Biochemistry, Molecular Biology or a closely related field
  • Minimum 3 years work experience in industry or academia, preferably in vitro diagnostics (IVD) field
  • Knowledge in molecular biology techniques, specifically DNA/RNA extraction and sample preparation, PCR, qPCR, RT-PCR, gel electrophoresis, and ELISA
  • Significant experience with hands-on lab skills: pipetting, aliquoting and calculating dilutions for reagents
  • Preferred, but not required: previous exposure to Quality Management System (QMS) documentation, statistical analysis software, Design of Experiments (DOE), cell culture, PCR primer design, and familiarity with Agilent Bioanalyzer
  • The ideal candidate is organized, meticulous, has excellent communication skills, is able to work well both independently and as part of team, and has flexibility to change directions as needed
  • Candidate is comfortable working with clinical samples and pathogenic organisms (BSL-2)

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 "Research Associate / Associate Scientist (Assay)” along with answers to the following: (1) How do you personally keep track of your pending deadlines and tasks? (2) In two sentences, describe your ideal work place. (3) Describe your personality in 4 words.