Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Fellow, Preclinical Research
Description
Preclinical Sciences plans and executes model development, safety, and efficacy studies supporting Interventional Cardiology, Vascular Surgery, Endosurgery, Neurovascular, Peripheral Interventions, and Corporate R&D combination medical devices to enable early product investment decisions, product approvals, and market launch. Study outcomes are represented in internal presentations, internal reports, external publications and regulatory submissions.
Key Responsibilities:
- Direct species selection. Lead creativity design to meet program objectives. Independently understand program and corporate requirements and provide scientific direction. Direction of program design, intent and rationale.
- Independent knowledge of competitive labs and processes. Approver of initial study documentation. Approver of protocol. Independently obtain resources for completion of program and proactively plan for contingencies. Independent direction of project timelines; setting of preclinical expectations within the department.
- Independent study analysis related to program objectives. Program data analysis directing decisions. Analysis of program data.
- Analysis of program data and interpretation. Independent decisions on program design and endpoints. Direction of program endpoints to address risk mitigation and safety. Interpretation of program endpoints to impact direction.
- Complaint reporting. Identify CAR/CAPA. Execute CAR/CAPA. Ensure up to date training.
- Takes a leadership role in improving or simplifying technical processes for BSC; Creates, refines, and champions BSC process, technology, and tools to our studies, trials, products and services. Negotiation/Influence: Influences technical decisions made by management and leadership within scope of function.
- Mentors and coaches others
Qualifications:
- Masters Degree required. PhD or Post Masters certificate/degree preferred.
- Minimum of 9 years, Biology or Veterinary profession
- 5 years of management experience required
- Mentors and coaches Senior and Principal level staff; may have direct reports
- In depth knowledge of vascular biology
- Regulatory experience is a plus
Working Conditions:
General office environment, and includes approximately 50% travel to research laboratory or hospital settings, meetings and/or other BSC facilities. Potential exposure to blood borne pathogens and other potentially infectious materials.