Sr. Preclinical Research Associate

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
Supports company efforts to develop, test, and verify the performance and efficacy of newly designed medical devices using animal studies and in vitro testing. The candidate is responsible for planning, conducting, and reporting the study, maintaining the integrity of pre-clinical data, and for ensuring that project timelines are met.  Acts as project resource personnel regarding the product under test and the pre-clinical study conduct. 

Your responsibilities will include:

• Serve as Study Director/Principal Investigator for preclinical in vivo studies (GLP and nGLP) at internal research facility
• Lead preclinical study conduct including protocol development, study management, data analysis, data interpretation and reporting
• Provide preclinical knowledge, expertise and direction all phases of development of a product or concepts
• Develop preclinical strategy and support including study design, study objectives, model development, and timelines supporting long-term project team goals.
• Ensures regulatory compliance with test protocols and all regulatory policies, procedures and/or guidelines during preclinical studies by training/guidance of investigators, evaluations and follow-up of corrective actions
• Support product development by contributing preclinical knowledge to bench testing, performing in-vitro and /or in-vivo device evaluations and assisting in the development of new in-vivo models to provide a better understanding of device performance
• Influence and lead decisions made by preclinical, research and development, and other functional management area within the business 
• Influence and contribute to collaboration across all functional areas within the Preclinical Department and across internal functions (R&D, Marketing and Regulatory)
• Ensure timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
• Provide accurate progress reports on preclinical projects as scheduled, by writing assigned preclinical portions of reports for submission to regulatory agencies, etc.
• Contributes to developing and writing preclinical protocols, and data sheets or case report forms for products and process changes, to gain regulatory approval for product release, additional claims, etc., by addressing issues from a preclinical perspective and by interacting with appropriate personnel.
• Establish and/or refine policy to ensure adherence to applicable ethical regulatory and preclinical standards by participating in the creation, review and approval of departmental operating procedures, protocols, data analysis and record keeping procedures for pre-clinical research
• Assist senior preclinical staff to improve, refine, simplify or create technical processes related to the conduct of preclinical studies and product development
• Participate in the development of less experienced staff by providing scientific guidance

Required qualifications: 

• Minimum of a Doctoral Degree (e.g. PhD, DVM, MD) in Biological Sciences, Biomedical Engineering or Design, Biochemistry, Veterinary Science or a related field 
• Minimum of 5 years of preclinical experience in the medical device or pharmaceutical industry 
• Experience in cardiovascular, peripheral, endoscopy or structural heart device development in large animal research, including study management, data analysis and reporting

 

Preferred qualifications: 

• Experience as a study director/principal investigator conducting GLP and non-GLP studies.  Knowledge of GLP regulations is highly desirable 
• Excellent communication, presentation, analytical and technical writing skills
• Highly motivated individual able to work in a semi-independent or independent manner, experience working in a collaborative, team-based environment 
• Skills with MS Office suite including Word, Excel, PowerPoint, MS Project, and data analysis programs
   

Requisition ID: 581016

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a dru