oseida is seeking an outstanding candidate to join our Clinical team. The Vice President, Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical operations and the management of staff responsible for our cell therapy and gene therapy products, with a particular focus on building the organization as the company grows. The individual must have the ability to work independently and also as an effective and engaged team member in a dynamic, fast-paced environment.
These may include but are not limited to:
- Build out and oversee the Clinical Operations function, processes and all activities related to execution of clinical studies and programs in accordance with regulatory guidelines
- Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas
- Recruit, motivate and provide oversight for all in-house clinical operations and external department staff and resources associated within clinical operations, CRO's and vendors
- Direct the successful execution of all clinical trials, programs, timelines and clinical milestones
- Oversight of Clinical Program Leaders for interdisciplinary project teams to ensure the successful execution of clinical programs and clinical operations
- Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and timely review of trial master files, etc.
- Manage budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
- Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, BLA, etc.
- Perform other duties as assigned.
Requirements, Knowledge, Skills and Abilities
- BS in a scientific discipline with 15+ years of Clinical Operations line management experience (an equivalent combination of education and experience may be considered). MS, PharmD or PhD is preferred.
- Extensive background in oncology pharmaceutical and biotech clinical research and development. Experience with CAR-T clinical programs is highly desirable
- Proven history of strategic drug development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (NDAs/INDs).
- Proven experience hiring, leading clinical operations teams and overseeing their career growth skills
- Experience managing a rapidly changing organization and integrating new personnel, processes and systems is essential, as well as, ability to evaluate and resolve complex problems
- Demonstrated experience in CRO and vendor management to support global clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required
- Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
- Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff
- Travel may be required up to 15%.