Senior R&D Manager — New Product Development & Regulatory Licensing

IDEXX defines innovation in the industries we serve with a world-class product portfolio and an impressive pipeline focused on the this role as Senior R&D Manager New Product Development & Regulatory Licensing you will lead a team of talented scientists through the development and regulatory licensing of newly developed diagnostic products partnering closely with Regulatory Affairs to bring those products to market in the US and around the world. You will be joining an innovative fast-paced environment with a strong focus on employee culture and development where your leadership directly shapes how our newest diagnostics reach the veterinarians and customers who rely on them.

• You will lead and develop a team of scientists whose work brings new diagnostic products to marketdirectly shaping the careers of your people the capabilities of our R&D organization and the success of IDEXX.

• You will own the technical strategy that turns scientific innovation into licensed products partnering with Regulatory Affairs to navigate registration in the US and around the globe.

• You will be the trusted expert who bridges science and regulationeducating internal stakeholders and helping regulatory reviewers understand the rationale behind our designsso that breakthrough diagnostics reach the customers pets people and livestock who depend on them.

• You will lead and develop a team of scientific employees including managers and individual contributors across a multi-level organization. You will assign work establish performance metrics monitor activities and evaluate performance. You will foster a high-performing collaborative and accountable team environment define best practices and standardization for technical licensing activities and documentation and lead the development of your groups procedures while contributing to the strategy and direction of the function.

• You will collaborate with Regulatory Affairs to lead the technical strategy for the registration of newly developed diagnostic products in the US and internationally. You will own the technical direction for study design protocol authoring execution data analysis and report documentation directing and advising R&D teams to ensure successful licensure. You will develop and drive regulatory strategies on a multi-year horizon take a holistic approach from concept through post-license activities and design innovative business-optimized approaches that balance scientific rigor with operational efficiency. You will partner cross-functionally with Regulatory Affairs and other internal stakeholders to ensure alignment and readiness for submission and review and you will proactively identify and mitigate risks related to study design regulatory acceptance and execution timelines. You will plan and organize this work provide for adequate staffing and resources and keep it on schedule.

• You will serve as the internal subject matter expert on the regulatory strategy for each product in your portfolio. You will educate internal stakeholders including R&D partners business leaders and senior leadership on regulatory requirements project risks timelines and scope to enable informed decision-making and prioritization translating complex regulatory frameworks and product attributes into clear actionable insights for both technical and executive partnership with Regulatory Affairs you will help educate regulatory agency reviewers on the technical aspects of our products including the rationale for proposed study designs and processes and you will influence agency acceptance of novel and non-traditional doing so you will help advance regulatory thinking and reinforce IDEXXs leadership in modernizing diagnostic evaluation approaches.

• PhD required in the life sciences or related areas along with at least 10 years of industrial experience working on the development of licensed diagnostic or pharmaceutical products regulated by a government agency. This includes products regulated by the USDA FDA or comparable agencies; depth in any one of these regulatory environments is what matters and the ability to transfer that expertise to veterinary diagnostics.

• 7 years of supervisory or managerial experience with in-depth experience in the areas managed and proven leadership skills is required. Experience as a manager of managers or leading a multi-level organization is highly valued.

• Demonstrated ability to lead technical strategy for product registration including experimental design protocol authoring execution data analysis and regulatory report documentation.

• Strong project management skills including the ability to develop timelines conduct risk assessments define scope and manage work streams across multi-year programs.

• People-leadership skills including team development engagement and the ability to direct and advise scientific teams as well as define best practices and standardization.

• Cross-functional leadership and influence with the ability to align partners across R&D Regulatory Affairs Quality and the business.

• Excellent communication skills both verbal and written including executive communication and stakeholder education with the ability to translate technical detail for varied audiences from senior business leaders to regulatory reviewers.

• Reasoning problem-solving and analytical skills to resolve complex multidisciplinary issues.

• General business knowledge including specific knowledge of the businesses supported plus excellent customer service and relationship-building skills.

• Personal computer skills including Microsoft Office.

• Fluency in the English language.

• Some travel is required.

The following experience is highly valued and would accelerate success in the role but is not required. We welcome candidates who bring strong transferable expertise from adjacent regulatory scientific or product-development environments.

• Expertise in USDA/CVB new-product licensing including familiarity with USDA/CVB regulations and compliance (e.g. Veterinary Services Memorandum 800.73) enabling a holistic approach from the Product Licensing Plan through post-license activities.

• Experience developing innovative licensing strategies including securing agency agreement to use non-traditional reference methods for evaluating diagnostic sensitivity and specificity establishing new evaluation paradigms.

• Skill in technical negotiation with regulatory agencies both written and oral and in supporting agency inspection and compliance activities as an R&D subject matter expert.

• Experience with outside-the-US (OUS) licensing in markets such as Japan Germany and others.

• Infectious-disease subject matter expertise.

• Hands-on expertise across immunoassays biomarkers and molecular assays qualitative and quantitative spanning assay design development and verification through launch.

• A record of publications white papers or other contributions supporting new product development.

• A track record of using AI tools to drive efficiencies in documentation processes such as protocol authoring and report generation.