Senior Director of Clinical Study Governance
About The Position
The Senior Director of Clinical Study Governance is a senior leadership role responsible for creating, implementing, and optimizing processes and procedures for using NYBCe-collected blood and cellular materials in clinical studies, including as starting materials for further manufacturing. The role also oversees governance processes for internal clinical studies and maintains collaborative, strategic, growth-oriented relationships with customers of these services. The position manages the process from study-request review through service delivery. This includes coordinating with Business Operations and Legal on pricing and contracts; supporting study plans, donor consents, and test protocols; training enterprise staff, including on human-subject protection; and collaborating to obtain appropriate IRB review and approval. The role also identifies suitable donors, arranges compliant procurement, processing, and transport of materials through the NYBCe network, maintains the advanced therapies donor database, and prepares KPIs and reports. The Senior Director attends conferences and seminars as required, recommends improvements to business-unit practices and processes, and performs related duties as assigned.
Requirements
- Bachelor’s degree in a life science-related field.
- 10–12 years of experience in the life science industry.
- At least 5 years of experience in clinical study management and working with IRBs.
- Knowledge of proper clinical study management and oversight.
- Knowledge of appropriate management of sensitive and personal information.
- Cultural competency and ability to communicate effectively and sensitively with individuals and groups from diverse backgrounds.
- Ability to work independently with minimal supervision.
- Clear verbal and written communication skills.
- Strong customer relationship management skills.
Responsibilities
- Create, implement, and optimize processes and procedures for using NYBCe-collected blood and cellular materials in clinical studies, including as starting materials for further manufacturing.
- Oversee governance processes for internal clinical studies.
- Maintain collaborative, strategic, growth-oriented relationships with customers of the services.
- Receive and vet study requests from customers or internal stakeholders.
- Partner with Business Operations and Legal to price and contract requested services.
- Support the creation of study plans, including donor consents and test protocols.
- Conduct enterprise training, including training on the protection of human subjects.
- Collaborate to obtain appropriate IRB review and approval of study plans.
- Identify appropriate donors for the materials needed to complete services.
- Arrange compliant procurement, processing, and transport of materials to customers through the NYBCe network.
- Maintain the advanced therapies donor database.
- Prepare KPIs and reports.
- Attend conferences and seminars as required.
- Recommend improvements to business-unit practices and processes.
- Perform related duties as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
