Senior R&D Manager New Product Development & Regulatory Licensing

Senior R&D Manager — New Product Development & Regulatory LicensingZum Hauptinhalt springen#Senior R&D Manager — New Product Development & Regulatory Licensing page is loaded## Senior R&D Manager — New Product Development & Regulatory LicensingBewerbenlocations: Westbrook, MEtime type: Full timeposted on: Heute ausgeschriebenjob requisition id: J-053627IDEXX defines innovation in the industries we serve with a world-class product portfolio and an impressive pipeline focused on the future. In 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.## **Why this role matters:*** You will lead and develop a team of scientists whose work brings new diagnostic products to market—directly 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 regulation—educating internal stakeholders and helping regulatory reviewers understand the rationale behind our designs—so that breakthrough diagnostics reach the customers, pets, people, and livestock who depend on them.## **In this role:*** **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 group's 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 audiences. In 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 methodologies. In doing so, you will help advance regulatory thinking and reinforce IDEXX's leadership in modernizing diagnostic evaluation approaches.## **What you need to succeed:*** PhD required in the life sciences or related areas.* 7+ years of supervisory or managerial experience, with in-depth experience in the areas managed and proven leadership skills is reqired. Experience as a manager of managers or leading a multi-level organization is valued.* 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.* 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.## **Highly desirable**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.## **What you can expect from us:*** Salary range starting at $160,000 based on experience* Opportunity for annual cash bonus and company equity* Health / Dental / Vision Benefits Day-One* 5% matching 401k* Additional benefits including but not limited to financial support, pet insurance, mental health resources, volunteer paid days off, employee stock program, foundation donation matching, and much moreIf you’re looking for a role that’ll challenge you, offer a variety of work and learning, while helping an amazing industry, we’d love to hear from you!## **Why IDEXX:**We’re proud of the work we do, because our work matters. An innovation leader in every industry we serve since 1983, our team members help pet owners worldwide keep their companion animals healthy and happy, ensure safe drinking water for billions, and help farmers protect livestock and poultry from disease.We have customers in over 175 countries and a collaborative global workforce. Our culture embraces challenges and encourages learning and discovery. At IDEXX, you’ll be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement.If meaningful work and a sense of purpose are at the top of your list, you’ll find it here. Let’s pursue what matters together.## **About the job location:**If you’re thinking about relocating for this role, here are a few things to know about living in Maine (often called “Vacationland”). The Westbrook, ME area provides great access to active downtown areas and the outdoors, with the coast and numerous mountains and hiking trails nearby. You’ll also find a number of large companies like ours in the area, creating a vibrant work culture.You can learn more on the Portland tourism website: values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.**IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited* *by local, state, or federal laws.**While we appreciate our staffing partners, we are unable to accept unsolicited agency resumes.**#LI-CAG* #J-18808-Ljbffr