Scientist / Study Director

American Preclinical Services (APS) is a privately held Contract Research Organization (CRO) located in the Minneapolis metro area. APS performs preclinical research for biotechnology companies developing medical devices and pharmaceuticals. APS conducts GLP safety studies, feasibility research, and training/educational programs in various therapeutic areas including: cardiovascular, endovascular, pulmonary, urogenital and neurovascular diseases.

 

APS is recruiting an individual for the position of Scientist / Study Director.  This Individual will be responsible for developing and maintaining client relationships by managing client sponsored GLP preclinical research from study initiation to completion. The Scientist / Study Director will help coordinate the activities of the technical staff and develop study performance processes that will ensure the integrity, accuracy, and timeliness of study data.

 



Duties and Responsibilities:

 

Serve as Study Director for Good Laboratory Practice (GLP) and non-GLP studies, duties to include: study design and development, protocol generation, data analysis, and report writing.

 

Serve as a scientific contact for clients and APS staff.

           

Counsel clients regarding appropriate study designs and animal models for their research needs.

           

Work in conjunction with the Chief Scientific Officer and Chief Operations Officer to develop and administer budgets, schedules, and performance standards. 

           

Work in conjunction with the Quality Assurance and Quality Control staff to develop and maintain study integrity and GLP compliant processes.

           

Manage and develop the technical staff, providing guidance based on client goals, organizational goals, and company policy.

           

Assist in the coordination and prioritizing of client research.

             

Conduct briefings and technical meetings for internal and external representatives.

 

Recommend and execute modifications to preclinical policies and procedures.

        

The Scientist / Study Director will report to the Chief Scientific Officer.



 

Minimum Education, Experience, and Skills:

3+ years of medical device research and development experience with a broad knowledge of animal models (swine, sheep, rabbits, and canine).

 

In-depth knowledge of GLP regulations and FDA medical-device preclinical-guidance documents is an absolute requirement.

 

Competent statistical skills.

 

Excellent communications skills (oral and written).

 

Strong organizational and interpersonal skills.

 

Demonstrated project management skills and analytical skills.

 

Demonstrated skill in scientific writing as evidenced by scientific publications and/or successful medical device regulatory submissions.

 

Other Desirable Attributes: MS, DVM or PhD and/or research experience or training in medical device research.

 

Experience in medical device design and utilization within a biomedical products company is desirable. 

 

Biocompatibility testing and/or electrophysiology experience.