Clinical Trial Manager
The Director Clinical Operations will have responsibility for all day-to day trial management and vendor management for one or more clinical studies in the NKGen Biotech. The Director Clinical Operations will also collaborate with other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget
- Responsible for the operational strategy and execution for one or more clinical programs
- Collaborate with other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget.
- Lead identification and selection of potential clinical vendors.
- Serve as issue escalation point for vendors on assigned clinical programs, including clinical CROs
- May manage direct reports including performance management and professional development planning for team members
- Contribute to the planning and implementation of clinical studies including scenario planning, forecasting enrollment and timelines, estimation of resources and budget, and development of operational strategies.
- Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations.
- Contribute and facilitate the development and maintenance of Clinical Operations
- Contribute and facilitate the development of standard clinical trial management plans and tools.
- Contribute and facilitate Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities.
- Oversee clinical site and sponsor GCP inspection preparation and support activities.
- Oversee study budget(s) and review/approve invoices.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Bachelor’s degree in life sciences, plus a minimum of 5 years of experience in the biotech/pharmaceutical industry.
- Minimum of 3 years in small pharma environment, including experience in early-stage therapeutic drug development cross-functional program teams.
- A background Oncology experience is required.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
- Exhibit an entrepreneurial spirit with “can-do” approach.
- Ability to effectively communicate and exhibit exceptional interpersonal skills; strong team player.
- Shift and or weekend work may be requested
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!