POSITION SUMMARY:

Develop and oversee pre-clinical research activities to support technology innovation for new and existing product development, support transitions from pre-clinical to human trials, and serve as company liaison to outside research institutions, research consultants, and clinicians.

DUTIES AND RESPONSIBILITIES (essential functions of position): 

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

·        Develop strategies and manage activities for basic science research funded by Orthofix Inc.

·        Manage, supervise and support physician and technical research consultants

·        Design synopses and protocols for pre-clinical and clinical research trials of new technologies and new products and support ongoing evaluations of marketed products

·        Develop relationships and act as liaison with academic and research centers, physician investigators and research consultants

·        Maintain awareness of current issues in research related to Orthofix Inc. interests

·        Review scientific literature for technological applications and valid animal and clinical models

·        Review statistical analysis plans for new pre-clinical and clinical protocols and support final analysis and interpretation of outcomes

·        Work with Product Managers to develop research programs for new and existing products

·        Assist with the development of written and verbal presentations of study data for symposia, scientific presentations and exhibits, and FDA submissions

·        Support Marketing, R&D, and Training departments as required on research matters and Regulatory Affairs on product approval submissions

·        Regular attendance required.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS: 

·        Advanced degree in a medical or related scientific discipline – Ph.D. preferred, engineering background a plus.

·        Significant industry experience in clinical research, 3+ years of related pre-clinical or clinical trial development and 2+ years of related corporate experience, medical device industry preferred

·        Working knowledge of the principles of research design and statistics

·        Working knowledge of cellular biology – bone biology a plus.

·        Excellent technical writing skills

·        Familiarity of FDA regulations and ICH-GCP guidelines

·        Thorough understanding of anatomy, physiology, and medical terminology

·        Excellent communication skills

·        Must work independently and in a team environment

·        Proficient computer skills using Microsoft Office products

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):

·        Experience with Orthopedic devices and/or research

·        Experience with device trials involving IDE-PMA submissions and post-market surveillance

SUPERVISORY RESPONSIBILITIES:

·        Possible direct and/or indirect reports as assigned

PHYSICAL DEMANDS AND WORK CONDITIONS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·        Regularly required to sit for extended periods of time, frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 25 lbs.

·        Eyesight and hearing must be correctable to standard level

·        Travel required up to 35%