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 the use of NYBCe-collected blood and cellular materials in clinical studies, including as starting materials for further manufacturing. The position also maintains collaborative, strategic, growth-oriented relationships with customers and oversees governance processes for internal clinical studies. The role manages the processes needed to provide appropriate clinical study oversight, from receiving and vetting study requests through planning, review, donor identification, compliant procurement, processing, and transport of materials. The position also supports enterprise training, maintains the advanced therapies donor database, and prepares KPIs and reports.
Requirements
- Bachelor’s degree in a life science-related field.
- 10–12 years of experience in the life science industry, including at least 5 years 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.
- Maintain collaborative, strategic, growth-oriented relationships with customers of these services.
- Establish and manage governance processes for oversight of internal clinical studies.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
