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.
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