Director of Clinical Operations

Histogenics, located in Waltham MA is a tissue regeneration company developing breakthrough treatments for long-lasting joint repair.  Its cartilage regeneration products apply advanced cell biology, tissue engineering and materials science in the repair of injured or diseased joints, to restore joint function and prevent degenerative disease.

 

Histogenics is growing and looking for talented individuals to join our team!

 POSITION SUMMARY:

 

Reporting to the Vice President, Regulatory, Clinical and Quality, the Director of Clinical Operations is responsible for development and execution of a strategy to ensure that all clinical study enrollment goals are met, and that clinical operations activities are conducted efficiently and in compliance with US requirements.

 MAJOR DUTIES AND RESPONSIBILITIES:

 Develop, implement, and support patient recruitment and retention strategies for clinical studies.Develops strategies and field activities to increase productivity and optimize value of clinical projects.Oversees strategy for study site feasibility and selection to insure optimal selection of sites and investigators.Liaise regularly with clinical investigators, study coordinators, monitors, and other external staff training to ensure timely and quality execution of studies.Provides in-service training to surgeons and clinical study staffAdvises cross functional teams on recruitment methodologies and recruitment metrics.

 QUALIFICATIONS:

 

  Work Experience: 

· 10 years direct medical device development/clinical study/clinical sales experience

· Experience in developing and implementing metrics and clinical study patient recruitment strategies.

· Experience in identifying solutions to recruitment issues and solving problems arising from recruitment.

· Experience with design and conduct clinical studies and training programs

· Experience developing and tracking appropriate metrics to assess clinical operations performance.

· Experience and comfort in the operating room.

· Familiarity with FDA Requirements.

 Skills (Technical Knowledge):

 Proficiency in Microsoft applications Strong analytical skills Strong training and mentoring skillsSkills (General Knowledge):

 

· Verbal and Written Skills

· Attention to detail and accuracy

· Ability to interface with multiple disciplines

· Project Management Skills – ability to multi-task

· Planning and Organizational Skills

· Interpersonal Skills – ability to work in a team oriented environment

· Flexibility and Creativity

· Communicates Openly

 Education:

 

· Requires a technical degree in Life Sciences, or equivalent experience

 

Prior experience in orthopedics, nursing is preferred

 

 

This position will require up to 75% domestic travel.