Clinical Affairs Director

IsoTis has established itself as a leader in the rapidly emerging field of orthobiologics (the use of biotechnology to treat musculoskeletal disease and injury). Our Company is becoming increasingly recognized throughout the industry and medical community.

Overall responsibility for management of clinical studies, Including project planning, budget, investigator and resource management.  Works closely with investigators and institutions to insure timely patient enrollment and reporting.  Recommends and implements innovative approaches to outcomes and other results analysis.  This position will be reporting to the VP of R&D/Chief Technical Officer.

Duties & Responsibilities:

·        Work with Principal Investigator to draft clinical protocols, case report forms, and patient consent forms for designated products.

·        Participate in identifying investigators and institutions to conduct appropriate clinical trials.  Prepare Institutional Review Board submission as necessary.

·        Coordinate the collection of prospective and retrospective clinical data.

·        Monitor, alone or with a contract organization, clinical research projects consistent with FDA regulations and guidelines, as applicable.

·        Assist in the dissemination of information between Regulatory & Development, and Sales & Marketing.

·        Conducts investigator meetings, including giving presentation to study site personnel.

·        Coordinate the integration of data between biostatisticians, surgical consultants and medical writers.

·        Supervise clinical research and monitoring staff.

·        Negotiate financial contracts and investigator agreements with investigators and surgeons.

·        Develop strategies for patient recruitment.

·        Track patient recruitment for all projects and their reimbursement to investigators.

·        Works effectively across departments to facilitate program goals.

Knowledge & Skills:

·        LPN, RN, PA or other medically trained distinction with orthopedic, spine or trauma preferred.

·        Expert knowledge of scientific principles and concepts

·        Knowledge of biologics

·        Project management

·        Working knowledge of  clinical outcomes measures and analysis

·        Knowledge of FDA regulatory requirements

·        Strong computer skills (proficiency in MS Office) and understanding of statistical analyses

IsoTis OrthoBiologics offers a comprehensive employee benefits package that includes Medical, Dental, Vision, Life Insurance, LTD and 401K.

For more company information please visit our website: www.isotis.com