bluebird bio

Clinical Research

• Oversee all aspects of clinical study management for a gene therapy product; manage one or more complex studies with minimal supervision.
• Plan and execute studies in support of regulatory filings: timelines, budget, team management, vendor oversight; oversee financial aspects and inspection readiness.
• Accountable for performance and delivery of all trial activities; manage complex cross-functional study-level issues and present to cross-functional groups/committees.
• Make study-level decisions, drive difficult team/vendor discussions to resolution, and manage competing priorities.
• Lead cross-functional teams or workstreams; act as point of escalation with partners and vendors and communicate complex/sensitive study information.
• Lead risk assessment, contingency planning, escalation, and approve corrective action plans; assist CRA team when deliverables are at risk.
• Review study data, communicate study status, risks, and issues internally and with outsourced partners.
• Implement new processes and procedures per SOPs and regulations/guidance.
• Serve as Clinical Subject Matter Expert for internal/external audits and agency interactions; prioritize relationship management with investigators, staff, and vendors.
• May present at external conferences; contribute to study publications; domestic and international travel may be required.

Senior Clinical Trial Manager

Director

•Provide high-touch, education, support & resources to patients and caregivers regarding the gene therapy treatment process, including pre-treatment considerations, treatment day logistics, and post-treatment expectations.
•Educate the patient on bluebird gene therapy coverage based on their benefits and the steps needed to gain prior authorization to ensure understanding of the process for access.
•Assess patient and caregiver needs, tailoring resources and education to ensure understanding, confidence, and support.
•Serve as a trusted point of contact for patients, ensuring questions are answered in a compassionate and compliant manner.
•Guide patients through the treatment journey, coordinating support services such as travel, lodging, reimbursement, and offering connection to resources.
•Identify potential barriers to treatment and implement proactive strategies to resolve access challenges in collaboration with cross-functional partners.
•Monitor patient milestones and adherence to treatment timelines, ensuring delivery of high-quality and timely support.
•Educate internal and external stakeholders on the program to drive awareness.
•Work with Qualified Treatment Centers (QTCs) to monitor patient status and facilitate patient support.
•Partner with QTCs, healthcare providers, and advocacy organizations to enhance patient and caregiver education, increase awareness of program services, and support treatment readiness.
•Communicate key insights and patient trends back to internal stakeholders to continuously refine engagement approaches and optimize program design.
•Contribute to the design and implementation of patient support initiatives, work instructions, and best practice resources.
•Utilize data, analytics, and patient feedback to identify opportunities for program improvement and drive execution excellence.

Senior Clinical Trial Manager

Associate Director, Patient Navigator