Director, Clinical Research Operations

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

Summary

 The Director of Clinical Research Operations will lead the strategic and operational execution of clinical programs across GeneDx. This role is responsible for overseeing clinical trial activities, ensuring regulatory compliance, and driving operational excellence in support of the company’s research and development goals. The ideal candidate will have deep expertise in clinical trial management, team leadership, and cross-functional collaboration in a genomics-focused environment.

Job Responsibilities

• Lead the operational strategy and execution of prospective clinical research studies, including site and GeneDx-sponsored efforts.
• Contribute to protocol development, study design, operational feasibility assessments, and other study-specific documentation. This will include collaboration with sites as well as leading the development of materials for GeneDx-sponsored research.
• Oversee study start-up, site management, monitoring, data collection, and close-out activities.
• Ensure internal coordination for study activities, including contracting and laboratory communications.
• Ensure compliance with GCP, HSR, and other applicable regulations.
• Collaborate with cross-functional teams including Medical Affairs, Product, Innovation, and Commercial to align research initiatives with strategic priorities.
• Identify and manage vendors needed to support clinical research activities (e.g., CROs, data management) to ensure quality and timely delivery.
• Develop and manage clinical operations budgets, timelines, and resource plans.
• Support regulatory submissions and interactions with health authorities as needed.
• Develop and maintain SOPs and work guides for clinical research operations.

People Manager

• Yes
• Build and mentor a high-performing clinical research operations team
• Lead and mentor internal and/or contract clinical research operations staff and clinical data managers
• Oversee resource allocation and workload across team members
• Provide coaching, performance feedback, and career development support
• Foster a collaborative, high-performing team culture

Education, Experience, and Skills

• Bachelor’s degree in life sciences, public health, or a related field.
• 10+ years of experience in clinical research operations, with at least 5 years in a leadership role.
• Proven experience managing clinical trials in genomics, rare disease, or precision medicine.
• Strong understanding of clinical trial regulations and guidelines.
• Knowledge of clinical research standards and compliance requirements preferred.
• Proficiency in Microsoft Office Suite and project management tools preferred.
• Excellent leadership, communication, and organizational skills.
• Attention to detail and commitment to producing high-quality work.
• Ability to work in a fast-paced, mission-driven environment.

Certificates, Licenses, Registrations

• Good Clinical Practice and Human Subjects Research Certification preferred

Physical Demands

• Ability to stand, walk, and sit for extended periods.

Work Environment

• Work is primarily performed in a remote office setting.
• Occasional travel may be required.

#LI-REMOTE

Pay Transparency, Budgeted Range$229,581—$275,494 USD

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Science - Minded, Patient - Focused. 

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts in what matters most. 

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.

SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.

From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:

TECHNICAL EXPERTISE

• High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
• Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.

CLINICAL EXPERTISE

• Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
• Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
• Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.

Learn more About Us here.

Our Culture

At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:  

• Be bold in our vision & brave in our execution. 
• Communicate directly, with empathy. 
• Do what we say we're going to do.  
• Be adaptable to change.  
• Operate with a bias for action.    

Benefits include:

• Paid Time Off (PTO)
• Health, Dental, Vision and Life insurance
• 401k Retirement Savings Plan
• Employee Discounts
• Voluntary benefits

GeneDx is an Equal Opportunity Employer.

All privacy policy information can be found here.