A well-funded, clinical phase Biotechnology client has engaged Junto HLS to recruit their Associate Director, Clinical Operations. The incumbent will provide key clinical management oversight on the operation and execution of trials within the clinical operations department and have a meaningful equity stake in the business.
- Oncology experience is required; immunotherapy experience a plus
- Manage internal and externally sourced clinical projects that are both regional and global in scope
- Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA regulatory requirements as well as ICH/GCP guidelines
- Develop strategies for efficient study conduct, data collection, subject management and safety monitoring
- Drive implementation of new company initiatives in terms of process improvement or new technology related to clinical research
- Independently design, develop and review study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms
- Oversee/lead study management team meetings and teleconferences with study vendors
- Manage study-specific CROs and vendors and contract CRAs as appropriate
- Central New Jersey
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.