Manager, Global Toxicology and Biocompatibility

Additional locations: Marlborough, MA; Arden Hills, MN

About The Role

Global Toxicology and Biocompatibility plays a critical role in medical device development at Boston Scientific, ensuring patient safety while enabling early product development decisions, supporting product design direction, enabling product approvals, and supporting market launch for product commercialization. The Manager, Global Toxicology and Biocompatibility, provides technical leadership and support for the development of robust toxicology and biocompatibility processes to meet global business objectives. This role is responsible for ensuring processes and staff support the overall biological evaluation of medical device products, including support for new product development, sustaining activities, and global regulatory submissions. This position interfaces with internal stakeholders to plan, resource, and execute biocompatibility deliverables to support divisional and operational priorities.

This role follows a hybrid work model, requiring employees to be in the local office at least three (3) days per week. Relocation assistance and employment visa sponsorship are not available for this position.

Responsibilities

• Provide strategic leadership and guidance on the Global Toxicology and Biocompatibility process
• Assist the Associate Director in setting Global Toxicology and Biocompatibility business objectives, influencing procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs
• Serve as a key resource for biocompatibility and toxicology expertise for medical devices and pharmaceutical products for the Global Toxicology and Biocompatibility organization and assigned business divisions
• Supervise scientific staff responsible for coordinating recommended biocompatibility testing with external research labs and assessing applicable test data
• Provide strategic guidance and interpretation of regulatory requirements related to medical device submissions for the global organization and assigned business divisions
• Develop close working relationships with R&D, regulatory affairs, quality engineering, and manufacturing, maintaining close communications with internal customers on biocompatibility and toxicology related deliverables
• Ensure biocompatibility and toxicology information and data is accurate, reliable, and supports business objectives
• May develop testing strategies, coordinate and monitor testing with external research labs, assess data, and author/review Biocompatibility Assessments and Reports for assigned business divisions
• Act as a key liaison to external Contract Research Organizations for biocompatibility and toxicology testing
• Demonstrate a primary commitment to patient safety and product quality in every decision

Requirements

• Bachelor’s degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field
• Minimum of 8 years of professional toxicology/biocompatibility experience, or minimum of 6 years with an advanced degree
• Minimum of 2 years of professional experience as a leader of technical people (not necessarily by means of direct reports)
• Complete understanding and wide application of principles, theories, and concepts in the biocompatibility of medical devices, including demonstrated expertise with ISO 10993
• Excellent written and verbal communication skills
• Experience working with regulatory authorities

Preferred Qualifications

• Advanced degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field
• Prior experience in medical device and/or pharmaceuticals
• Comfortable in a dynamic environment and able to work independently as well as on teams
• Results-oriented and detail-oriented, able to multi-task while working within aggressive timelines
• Proven leadership and management of a technical group, providing coaching and development
• Applied knowledge and understanding of toxicology principles and best practices
• Working knowledge of quantitative toxicological risk assessment methodologies

Pay

Minimum Salary: $106,800
Maximum Salary: $202,900

Compensation will vary based on location, experience, education, and other relevant factors. It may include variable compensation such as overtime, shift differentials, annual bonuses, and long-term incentives, subject to eligibility and plan requirements.

Benefits

Boston Scientific offers a comprehensive benefits package, including core and optional employee benefits. For more details, visit www.bscbenefitsconnect.com.