Role Overview for VP Molecular Assay Development – Boston, MA
The Vice President of Molecular Assay Development is a critical, high-impact leadership role responsible for directing the entire lifecycle of our client’s diagnostic product pipeline. This executive will provide the strategic vision, scientific leadership, and operational oversight necessary to build and advance a portfolio of innovative molecular assays from concept through to regulatory submission and commercial launch. Reporting directly to the Chief Scientific Officer, the VP will lead a dynamic, multi-disciplinary team of scientists and researchers, fostering a culture of scientific excellence, collaboration, and urgency. This is a unique opportunity to shape the scientific direction of a rapidly growing company and make a tangible difference in the lives of patients worldwide. The ideal candidate is not only a world-class scientist but also a strategic thinker and an inspirational leader capable of translating complex scientific challenges into successful commercial products. You will be the primary architect of the company’s technical success, ensuring that all assay development programs are executed with rigor, efficiency, and a steadfast commitment to quality.
Key Responsibilities of VP Molecular Assay Development – Boston, MA
Strategic and Technical Leadership
Develop and execute a comprehensive, long-term strategy for the Assay Development department that aligns with the company’s overarching corporate goals. Define the technology roadmap, identify new opportunities for diagnostic products, and champion innovation across the organization. Provide expert scientific and technical guidance on all aspects of molecular assay design, feasibility, optimization, verification, and validation.
Team Building and Mentorship
Recruit, lead, mentor, and develop a high-performing team of scientists and research associates. Foster a collaborative, results-oriented, and innovative culture that encourages scientific curiosity and professional growth. Set clear goals, provide regular feedback, and manage team performance to ensure departmental objectives are met.
Program and Portfolio Management
Oversee the entire portfolio of assay development projects, ensuring they are delivered on time, within budget, and to the highest quality standards. Implement robust project management methodologies, establish key performance indicators (KPIs), and manage resources effectively across multiple concurrent programs. Proactively identify and mitigate risks to project timelines and deliverables.
Regulatory and Quality Compliance
Ensure all assay development activities are conducted in strict compliance with applicable regulatory and quality standards, including Design Control, QSR, and ISO 13485. Lead the team in preparing the necessary documentation for regulatory submissions (e.g., 510(k), PMA, CE-IVD). Serve as the subject matter expert during regulatory audits and inspections. A deep understanding of FDA regulations for medical devices is paramount.
Cross-Functional Collaboration
Act as a key liaison and build strong collaborative relationships with other functional leaders, including R&D, Bioinformatics, Software Engineering, Clinical Affairs, Quality Assurance, and Commercial teams. Ensure seamless integration of assay development with other aspects of product development to create a cohesive and robust diagnostic system.
Technology Transfer and Manufacturing Support
Oversee the successful and efficient transfer of validated assays and associated processes to manufacturing and/or clinical laboratory operations. Collaborate closely with the manufacturing team to ensure assays are scalable, robust, and cost-effective.
Innovation and Intellectual Property
Stay abreast of the latest advancements in molecular diagnostics technologies, platforms, and methodologies. Drive the evaluation and implementation of new technologies to maintain the company’s competitive edge. Work with legal counsel to identify and protect novel intellectual property arising from the team’s research and development efforts.
Budget and Resource Planning
Develop and manage the annual departmental budget, including headcount, capital expenditures, and operational costs. Ensure prudent financial management and optimal allocation of resources to support strategic priorities.
Requirements for the VP Molecular Assay Development – Boston, MA
Educational Background
A Ph.D. in Molecular Biology, Genetics, Biochemistry, or a closely related scientific discipline is required.
Executive Experience
A minimum of 15 years of progressive experience in the biotechnology or diagnostics industry, with at least 8 years in a senior leadership role managing assay development teams. Proven track record of successfully leading teams to develop and commercialize IVD or LDT products.
Technical Expertise
Deep, hands-on expertise in the design, development, and validation of complex molecular assays. Extensive experience with a variety of modern molecular biology techniques and platforms, including qPCR, digital PCR (dPCR), and Next-Generation Sequencing (NGS). Experience with automation and high-throughput workflows is highly desirable. Specific experience in oncology (e.g., liquid biopsy, ctDNA analysis) or infectious disease diagnostics is strongly preferred.
Regulatory Acumen
Demonstrated success in developing diagnostic products under a rigorous quality management system (QMS) in compliance with FDA 21 CFR 820, ISO 13485, and/or CLIA/CAP regulations. Direct experience authoring and contributing to successful regulatory submissions (510(k), de novo, PMA) is essential.
Leadership and Management Skills
Exceptional leadership capabilities with a proven ability to build, inspire, and retain top scientific talent. A strategic mindset with the ability to align scientific initiatives with business objectives. Excellent problem-solving, decision-making, and organizational skills.
Communication and Interpersonal Skills
Outstanding written and verbal communication skills. The ability to articulate complex scientific concepts and strategies clearly and concisely to a wide range of audiences, from the lab bench to the Board of Directors. Strong collaborative spirit and the ability to influence across a matrixed organization.
Benefits & Perks Offered
Our client is committed to attracting and retaining the best talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
- A highly competitive base salary, annual performance-based bonus, and a significant equity stake in a promising, high-growth company.
- Comprehensive health, dental, and vision insurance plans for you and your dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), paid holidays, and flexible work arrangements to promote work-life balance.
- A dedicated budget for professional development, including attendance at major scientific conferences and leadership training.
- Relocation assistance for qualified candidates moving to the Boston area.
- The opportunity to work in a state-of-the-art facility alongside a team of brilliant and passionate colleagues.
- A dynamic, mission-driven culture where your contributions will have a direct and meaningful impact on advancing human health.
How to Apply
This is a retained search conducted by JRG Partners. If you are a visionary scientific leader with the experience and passion to drive the next generation of molecular diagnostics, we invite you to apply for this career-defining opportunity. To be considered, please submit your curriculum vitae and a detailed cover letter highlighting your relevant experience and leadership accomplishments. JRG Partners is a leader in recruiting top talent for the life sciences sector. To learn more about our specialized expertise in this field, we invite you to visit our Molecular Technologist Recruiters Practice page. We look forward to reviewing your application.
