Director of Clinical Operations

Watertown, Massachusetts, United States | Full-time

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The Director of Clinical Operations will lead the strategic direction and operational aspects of clinical development for Affera’s Class II and III medical devices.

This position will be responsible for developing and implementing a strategic clinical plan through pivotal clinical trials to support regulatory submissions.

Responsibilities

  • Develop strategic direction and priorities for clinical development, working with Engineering, Quality, Regulatory Affairs, and Operations leadership to define clinical development projects including objectives, work plans, milestones and deliverables.
  • Design and execute pivotal clinical trials in line with Affera SOPs, Good Clinical Practice, ISO 14155, and relevant guidance, including prioritizing indications, choosing appropriate populations and endpoints, planning and executing statistical analysis, and identifying risks and benefits.
  • Provide overall clinical site management from qualification/start-up to closeout, including contracting, training, site initiation, monitoring, and reports.
  • Prepare clinical evaluation reports and contribute to pre-subs, 510(k)s and other regulatory submissions.
  • Work cross-functionally with Quality, Regulatory Affairs, and Engineering teams, as appropriate to support efforts in these areas.

Preferred Qualifications and Experience

  • BS or higher in a technical or clinical discipline (engineering, biology/life sciences).
  • 5+ years clinical research experience in a medical device setting.
  • Experience with Electronic Data Capture (EDC) systems.
  • Demonstrated experience with major regulatory submissions – PMA, 510(k), etc.
  • Previous experience in a pivotal IDE trial with a cardiovascular device preferred.
  • Excellent analytical skills required; some formal training in statistics is preferred.
  • Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a start-up environment.
  • Ability and willingness to travel.

Perks: 

  • Contribute to an innovative solution that can improve the lives of millions.
  • Learn under the guidance of some of the industry's prominent experts in the field of medical device engineering.
  • Bright, motivated co-workers in a fun and collaborative office environment.
  • Competitive salary, 401k, medical coverage to suit your needs.