Role Overview for Director of R&D (Diagnostics)
JRG Partners, a premier executive search firm specializing in the life sciences and medical device sectors, is thrilled to partner with a pioneering diagnostics company at the forefront of healthcare innovation. We are searching for an exceptional and visionary Director of R&D (Diagnostics) to lead our client’s groundbreaking research and development initiatives. This pivotal role is based in the vibrant biotech hub of Cambridge, MA, and offers a unique opportunity to shape the future of diagnostic medicine.
As the Director of R&D, you will be instrumental in defining and executing the strategic direction for novel diagnostic product development. You will lead a talented team of scientists and engineers, fostering a culture of innovation, scientific rigor, and operational excellence. This role demands a leader with a deep understanding of the diagnostics landscape, a proven track record in bringing complex IVD products from concept to commercialization, and an unwavering commitment to improving patient outcomes through innovative diagnostic solutions.
Our client is dedicated to developing cutting-edge diagnostic technologies that provide timely, accurate, and actionable insights for clinicians and patients. They pride themselves on a collaborative environment where scientific curiosity meets commercial drive. The successful candidate will be a strategic thinker, an inspiring leader, and a hands-on problem-solver capable of navigating the complexities of product development within a regulated environment. If you are passionate about pushing the boundaries of diagnostic science and making a tangible impact on global health, we invite you to explore this unparalleled opportunity.
Key Responsibilities of Director of R&D (Diagnostics)
Strategic R&D Leadership
Define, develop, and implement the R&D strategy for new diagnostic platforms and assays, ensuring alignment with the company’s overall business objectives and market needs.
Team Leadership and Development
Lead, mentor, and inspire a multidisciplinary team of scientists, engineers, and research associates. Foster a high-performance culture focused on innovation, collaboration, and continuous professional growth. Oversee talent acquisition, performance management, and career development plans for the R&D department.
Product Lifecycle Management
Drive the entire product development lifecycle from ideation and feasibility studies through design, verification, validation, transfer to manufacturing, and post-launch support. Ensure adherence to design control principles and best practices.
Technical Expertise & Innovation
Provide deep technical expertise in areas such as molecular diagnostics, immunoassays, clinical chemistry, point-of-care diagnostics, and assay development. Stay abreast of emerging technologies, scientific advancements, and competitive landscapes to identify new opportunities and challenges.
Cross-Functional Collaboration
Collaborate extensively with Clinical Affairs, Regulatory Affairs, Quality Assurance, Manufacturing, Marketing, and Commercial teams to ensure seamless product development, regulatory compliance, and successful market introduction. Act as a key scientific and technical liaison.
Budget & Resource Management
Develop, manage, and monitor the R&D budget, ensuring efficient allocation of resources and timely project completion. Identify and mitigate technical and operational risks across all R&D projects.
Intellectual Property Strategy
Contribute to the company’s intellectual property strategy by identifying patentable inventions, preparing patent applications, and managing the patent portfolio in collaboration with legal counsel.
Regulatory Compliance
Ensure all R&D activities comply with relevant regulatory standards and guidelines, including FDA (e.g., 21 CFR Part 820, IVDR), CE-IVD, ISO 13485, and other global regulatory requirements. Experience navigating the In Vitro Diagnostics (IVD) regulatory landscape is critical.
External Partnerships
Evaluate and manage relationships with external partners, academic institutions, and contract research organizations (CROs) to leverage specialized expertise and accelerate development timelines.
Scientific Communication
Represent the company at scientific conferences, industry events, and with key opinion leaders. Publish scientific findings and contribute to the company’s scientific reputation.
Requirements for the Director of R&D (Diagnostics)
Education
Ph.D. in a relevant scientific or engineering discipline such as Molecular Biology, Biochemistry, Cell Biology, Bioengineering, Biomedical Engineering, or a closely related field.
Experience
Minimum of 10-15 years of progressive experience in In Vitro Diagnostics (IVD) R&D within the medical device or biotechnology industry, with at least 5-7 years in a leadership or management role overseeing multidisciplinary teams.
Technical Expertise
-
- Extensive hands-on experience in the development and commercialization of IVD products, including assay design, optimization, verification, and validation.
- Proven expertise in at least one of the following areas: molecular diagnostics (PCR, NGS, isothermal amplification), immunoassays (ELISA, chemiluminescence, lateral flow), clinical chemistry, or point-of-care diagnostics.
- Strong understanding of reagent formulation, instrument integration, and software development for diagnostic platforms.
- Familiarity with statistical methods for data analysis, experimental design (DOE), and analytical performance evaluation.
Leadership & Management Skills
-
- Demonstrated ability to lead, motivate, and develop high-performing scientific and technical teams.
- Exceptional project management skills with a track record of successfully delivering complex R&D projects on time and within budget.
- Strong strategic planning capabilities with the ability to translate scientific vision into actionable development plans.
Regulatory Knowledge
In-depth knowledge of global regulatory requirements for IVDs (e.g., FDA 510(k), PMA, De Novo, CE-IVD marking, ISO 13485). Experience with quality management systems.
Communication & Interpersonal Skills
Excellent written and verbal communication skills, with the ability to present complex technical information clearly and concisely to diverse audiences, including senior leadership, scientific peers, and external stakeholders. Strong negotiation and influencing skills.
Problem-Solving
Highly analytical with a proactive approach to identifying and solving complex technical and scientific challenges.
Benefits & Perks Offered
Our client understands that their success is driven by the talent and dedication of their employees. They offer a comprehensive and competitive benefits package designed to support your health, financial well-being, and professional growth. This includes:
Competitive Compensation
An attractive base salary commensurate with experience, combined with a performance-based bonus structure.
Comprehensive Health & Wellness
Medical, dental, and vision insurance plans, including generous employer contributions, to ensure you and your family have access to top-tier care.
Financial Security
A robust 401(k) retirement plan with company match, along with life insurance and disability coverage.
Work-Life Balance
Generous paid time off (PTO), including vacation, sick days, and company holidays, to ensure you have time to recharge and pursue personal interests.
Professional Development
Opportunities for continuous learning, professional training, conference attendance, and career advancement within a rapidly growing organization. We invest in our leaders.
Impactful Work
The chance to contribute to the development of life-changing diagnostic products that directly improve patient health and clinical decision-making on a global scale.
Innovative Environment
Work in a state-of-the-art facility with access to cutting-edge technologies and collaborate with brilliant minds in the biotech industry.
Employee Well-being Programs
Access to wellness programs, employee assistance programs, and a supportive, inclusive company culture that values diversity and encourages collaboration.
Relocation Assistance
For qualified candidates, relocation support may be provided to facilitate a smooth transition to the vibrant Cambridge, MA area.
How to Apply
If you are a driven and experienced R&D leader with a passion for diagnostic innovation and possess the qualifications outlined above, JRG Partners invites you to apply for this exceptional opportunity. This is a chance to join a forward-thinking company and make a significant impact on the future of healthcare.
To express your interest and be considered for this role, please submit your detailed resume and a compelling cover letter outlining your relevant experience and leadership philosophy. Your application will be handled with the utmost confidentiality.
Please apply directly through our JRG Partners portal or by sending your materials to our specialized recruitment team. We look forward to reviewing your application and discussing how your expertise can contribute to our client’s success.
For more information on how JRG Partners excels in connecting top talent with leading organizations in the life sciences sector, please visit our Life Sciences & Biotech Executive Search page.
JRG Partners is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit, and business need.
