ResponsibilitiesThe Senior Director of Clinical Study Governance is a senior leadership role responsible for the creation and implementation of process and procedures required to properly utilize NYBCe collected blood and cellular materials for clinical studies, including use of NYBCe materials as starting materials for further manufacturing. This position is additionally responsible for maintaining collaborative, strategic, growth-oriented relationships with customers of these services.
Additionally, this position is responsible for the governance processes for oversight over internal clinical studies.
This position is responsible for the creation, implementation, and optimization of the processes required to properly provide oversight for clinical studies including, but not limited to:
- Properly receive and vet a study request from a customer or internal stakeholder.
- Partner with Business Operations and Legal to price and contract the desired services.
- Support the creation of study plans, including donor consents and test protocols.
- Conduct training for the enterprise, including for the protection of human subjects.
- Collaborate to obtain appropriate IRB review and approval of study plans.
- Identify appropriate donors of the material(s) needed to complete the service.
- Arrange compliant procurement, processing, and transport of the material to the customer via the NYBCe network.
- Maintain the advanced therapies donor database.
- Prepare KPIs and reports.
- Attends conferences, seminars, as required.
- Makes recommendations to improve business unit practices and processes.
- Any related duties as assigned.
Qualifications
Education:
- Bachelor’s Degree in a life science related field is required.
Experience:
- Candidate must possess 10-12 years of experience in the life science industry. Minimally 5 years of this experience must be in clinical study management and working with IRBs.
Knowledge:
- Proper clinical study management and oversight.
- Appropriate management of sensitive and personal information.
Skills:
- Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
- Ability to work independently with minimal supervision.
- Ability to communicate clearly both verbally and in writing.
- Strong customer relationship management.
For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $200,000 p/yr. to $210,000 p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.
