Clinical stage biopharmaceutical company seeks a Associate Director of Clinical Operations to oversee clinical strategies and study protocols ensuring they are translated into operational plans for assigned studies. He or she, working closely with medical affairs or clinical development, will have oversight of clinical trials vendors, both operations and selection. We are specifically looking for candidates with Phase IV clinical trial experience. This exciting biopharmaceutical company’s first promising drug product received FDA approval in December of 2020 and has another gene therapy product in Phase I trials.
Requirements for Associate Director of Clinical Operations
- Bachelor’s degree in biological sciences, or health sciences, advanced degree preferred.
- 8+ years’ experience in clinical development operations or medical affairs operations with at least 5 years in a study management capacity
- Experience managing Phase IV studies REQUIRED
- Experience managing Phase I-III studies strongly preferred
- Previous experience at a sponsor/pharmaceutical company
- Previous experience with vendor management of a CRO is strongly preferred
- Strong organizational skills and ability to manage multiple studies
- Good communication skills, written, verbal, presentation and electronic.
- Ability to work across locations and time zones
- Ability to prioritize and work on multiple competing projects
- Strong financial business acumen and analytical skills
- Strong interpersonal skills and ability to manage multiple vendors
- Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas
- Able to travel, including international travel, for at least 20% of time, depending on business needs.