bluebird bio’s growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. This is not your typical development operations role – come make your mark with us!
bluebird bio is searching for a pragmatic and creative thinker who is responsible for Clinical Development Operations Clinical Compliance at bluebird bio. This role will partner with the Clinical Development Operations team and other functions, providing expertise and guidance regarding regulatory requirements, GCP guidelines, and industry best practices for the conduct of clinical studies. You will identify and escalate compliance issues, enable process improvement, facilitate risk assessments and risk-based decisions, and support the development and execution of comprehensive CAPA plans to address clinical quality and compliance risks both internally and externally.
About the role:
- Develop strong relationships with and provide leadership to Clinical Development Operations stakeholders across functions and teams, providing expert compliance guidance on GCP-related activities and issues
- Oversee inspection readiness activities in Clinical Development Operations in preparation for sponsor and clinical investigator site inspections.
- Facilitate risk assessments of clinical protocols and clinical trial activities in order to identify critical processes and data, high-risk vendor and investigator sites, and establish key risk indicators (KRIs) for proactive oversight
- Complete gap analyses to identify opportunities for process improvement and drive the development of SOPs and tools compliant with ICH GCP principles
- Lead eTMF excellence initiative
- Identify and escalate significant quality and compliance issues to the Head of Clinical Development Operations and leadership in Quality Assurance.
- Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
- Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
- Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc. Expected to present at industry meetings as an expert in global clinical trial operations.
- Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
- Travel up to 15% of the time.
- Bachelor’s Degree in life sciences required, Master’s or above preferred.
- Minimum of 12 years of pharmaceutical or biotechnology industry experience, with at least 7 years in a GCP quality assurance/clinical compliance role
- Proven track record of developing and coaching direct reports
- Thorough knowledge and understanding of drug development and the clinical trial process.
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Registration (BLA/NDA/MAA) submission experience, specifically running or taking a lead role in sponsor inspections
- Deep understanding of managing external relationships, specifically with Investigators, advisors, other study personnel, clients and vendors.
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Independently motivated, detail oriented, and good problem solving ability
- Excellent analytical and organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications skills and ability to influence across multiple functions
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.