Director Assay Development Molecular Diagnostics – Boston, MA

Are you an innovative leader passionate about advancing molecular diagnostics through cutting-edge assay development? We are seeking a Director of Assay Development to join our forward-thinking team in Boston, MA. This pivotal role offers a unique opportunity to lead the design, optimization, and validation of novel molecular diagnostic assays that directly impact patient care and clinical outcomes. If you thrive in a collaborative environment where science meets technology and leadership drives innovation, this is the position for you.

Lead Innovation in Molecular Diagnostics

Join a leading molecular diagnostics company based in Boston, MA, as the Director of Assay Development. You will oversee cross-functional teams and manage projects that develop high-quality, robust assays for clinical applications. The ideal candidate brings extensive expertise in molecular biology, assay design, and regulatory standards, along with a strategic vision to drive product development pipelines forward. If you are ready to make a significant impact in a fast-evolving field and shape the future of diagnostics, we want to hear from you.

Key Responsibilities of the Director Assay Development – Molecular Diagnostics

Assay Development Leadership: Lead the design, optimization, and validation of molecular diagnostic assays across various platforms. Develop robust protocols that meet clinical performance requirements and regulatory standards.

Project Management & Cross-Functional Collaboration: Manage multiple assay development projects simultaneously, coordinating closely with R&D, clinical, regulatory, and manufacturing teams to ensure timely and successful product delivery.

Innovation & Technology Integration: Drive innovation by evaluating and integrating emerging molecular technologies, reagents, and instrumentation to enhance assay sensitivity, specificity, and throughput.

Regulatory Compliance & Documentation: Ensure all assay development activities comply with regulatory guidelines (e.g., FDA, CLIA) and internal quality standards. Oversee the preparation of technical documentation and support regulatory submissions.

Team Leadership & Talent Development: Build, mentor, and lead a high-performing assay development team. Foster a collaborative culture focused on scientific excellence, continuous improvement, and professional growth.

Data Analysis & Performance Monitoring: Analyze assay performance data rigorously, troubleshoot technical challenges, and implement corrective actions to optimize assay reliability and reproducibility.

Stakeholder Communication: Act as a key scientific liaison with internal stakeholders and external partners, providing regular updates on project status, technical insights, and strategic recommendations.

Resource & Budget Management: Plan and manage departmental budgets, resource allocation, and vendor relationships to support efficient and cost-effective assay development activities.

Strategic Planning & Product Pipeline Contribution: Collaborate with leadership to define assay development roadmaps aligned with company goals, market needs, and clinical applications.

What the Client is Looking for in You

As the Director of Assay Development for Molecular Diagnostics, the client seeks a visionary scientific leader with a proven track record of delivering high-quality, clinically relevant molecular assays. You should be a results-oriented innovator who thrives in a dynamic R&D environment and can lead multidisciplinary teams to develop assays that push the boundaries of diagnostic accuracy and reliability.

Proven Expertise in Molecular Assay Development

The ideal candidate has deep hands-on experience in molecular biology techniques such as PCR, qPCR, NGS, or isothermal amplification methods. You should demonstrate success in designing, optimizing, and validating diagnostic assays within regulated environments, ideally in the molecular diagnostics or biotechnology industry. Experience with assay automation and platform integration is highly desirable.

Strategic and Scientific Visionary

You must have the ability to translate complex scientific concepts into actionable development plans that align with business goals and market needs. The client values leaders who can anticipate future trends in molecular diagnostics and proactively innovate to maintain competitive advantage.

Strong Regulatory and Quality Mindset

A comprehensive understanding of regulatory requirements (FDA, CLIA, ISO) related to diagnostic assay development is essential. You should be adept at generating technical documentation and supporting submissions to regulatory agencies while ensuring rigorous quality standards throughout development processes.

Effective Team Builder and Leader

Leadership skills are critical — the client wants someone who can recruit, mentor, and inspire a talented team of scientists and technicians. You should foster a culture of collaboration, scientific rigor, and continuous improvement, ensuring that team members grow alongside the company’s ambitions.

Analytical Problem Solver and Data-Driven Decision Maker

You should be proficient in analyzing experimental data, troubleshooting assay challenges, and making informed decisions to drive assay performance and reliability. A data-centric approach and attention to detail will set you apart.

Collaborative Communicator and Stakeholder Partner

Strong interpersonal skills are required to effectively communicate complex technical information to internal teams, external partners, and executive leadership. You will act as a key liaison, advocating for assay development priorities and ensuring alignment with organizational objectives.

Resource and Budget Management Skills

The client values candidates who can strategically manage departmental resources and budgets, balancing innovation with operational efficiency to deliver projects on time and within scope.

FAQs About the Role – Director Assay Development Molecular Diagnostics

What are the key responsibilities of the Director Assay Development?

As the Director of Assay Development, you will lead the design, optimization, and validation of molecular diagnostic assays. You will oversee project management, collaborate with cross-functional teams, ensure regulatory compliance, and drive innovation to deliver high-quality diagnostic products that meet clinical and market needs.

What qualifications and experience are required for this position?

The ideal candidate will have advanced scientific training (MS or PhD) in molecular biology or related fields, with substantial hands-on experience in assay development within molecular diagnostics or biotechnology industries. Proven expertise in techniques like PCR, qPCR, NGS, and experience working in regulated environments (FDA, CLIA) is highly preferred.

What leadership qualities are essential for this role?

Strong leadership and team management skills are critical. The client seeks a collaborative and inspiring leader who can mentor a multidisciplinary team, foster innovation, and maintain high standards of scientific rigor and quality. Effective communication and problem-solving abilities are essential.

What challenges can I expect in this role?

Challenges include managing multiple complex assay projects simultaneously, meeting stringent regulatory requirements, troubleshooting technical issues, and staying ahead of emerging technologies in molecular diagnostics. Balancing innovation with timelines and budgets will be key.

How will my work impact the company?

Your leadership in assay development will directly contribute to the company’s ability to launch reliable, clinically impactful diagnostic tests. This role is pivotal to advancing patient care solutions and maintaining the company’s competitive edge in the molecular diagnostics market.

What is the company’s culture and work environment like?

The company promotes a collaborative, fast-paced, and science-driven culture. It encourages continuous learning, innovation, and teamwork, providing a supportive environment where scientific excellence and operational efficiency are equally valued.

What Remuneration Can You Expect from This Job?

As the Director of Assay Development in Molecular Diagnostics based in Boston, MA, you can expect a highly competitive compensation package that reflects the critical nature of this leadership role in a cutting-edge industry. The remuneration typically includes:

Base Salary

The base salary for a Director-level role in molecular diagnostics generally ranges from $140,000 to $210,000 annually, depending on the company size, technology focus, and candidate experience. Companies with extensive R&D pipelines or public listings may offer salaries at the higher end of this spectrum.

Performance-Based Bonuses

In addition to the base salary, performance-based bonuses are often awarded based on successful assay development milestones, regulatory approvals, and contribution to product launches. These bonuses typically range from 10% to 30% of the base salary.

Equity & Stock Options

Many organizations in molecular diagnostics provide equity incentives such as stock options or restricted stock units (RSUs). These align your rewards with company growth and success, offering significant long-term financial upside, especially in high-growth biotech firms.

Long-Term Incentive Plans (LTIPs)

Some employers offer LTIPs or profit-sharing plans that reward sustained leadership performance and innovation over multiple years, reinforcing a commitment to long-term company goals.

Comprehensive Benefits & Perks

Typical executive benefits include:

Health, dental, and vision insurance
Retirement savings plans with company matching
Flexible working arrangements
Professional development opportunities
Relocation assistance if applicable

Signing Bonuses & Relocation Assistance

For highly qualified candidates, signing bonuses and relocation packages may be offered to facilitate a smooth transition to Boston, with bonus amounts varying by company size and candidate background.

Total Compensation Potential

When combining base salary, bonuses, equity, and benefits, total annual compensation for a Director of Assay Development can range from $160,000 to $280,000 or more at leading molecular diagnostics firms. High-impact leaders in innovative companies may receive even more attractive packages.

How to Apply

If you are an innovative and experienced leader in molecular diagnostics with a strong background in assay development, we invite you to apply for the Director of Assay Development position based in Boston, MA. This is a compelling opportunity to lead assay design and development initiatives, drive scientific innovation, and contribute to advancing cutting-edge diagnostic technologies.

To apply, please submit your resume along with a detailed cover letter highlighting your experience in molecular assay development, team leadership, regulatory compliance, and project management. Emphasize your success in developing high-quality diagnostic assays, managing cross-functional teams, and driving product development timelines in fast-paced environments.

This role offers the chance to make a significant impact on the future of molecular diagnostics by leading a talented team and collaborating across R&D, clinical, and regulatory functions. Apply today to take the next step in your career as Director of Assay Development in Molecular Diagnostics in Boston, MA!

For more information or to explore similar opportunities, please visit our Molecular Diagnostics Recruiting Experts Page.

Job Category: Molecular Diagnostics

Job Type: Full Time

Job Location: Boston

Director Assay Development Molecular Diagnostics – Boston, MA