Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to an Associate Director of Clinical Development Operations, you will be responsible for all aspects of clinical trial management for a novel gene therapy-based approach for our exciting and growing sickle cell disease program. Responsibilities include study planning and execution, timelines, budget, and vendor management. You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of bluebird bio’s products.
About the role:
- Oversee one or more concurrent clinical studies. Represent the clinical operations function on the clinical trial team. Lead and coordinate study management meetings.
- Manage and provide day-to-day oversight of full service CRO, third-party-vendors, contract monitors; including set-up, logistics, documentation, and clinical supplies needed for clinical trials.
- Manage trial budgets and timelines. Forecast external trial resource needs; accountable for the trial level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager. Contribute to developing SOWs, site budgets, CTAs, etc.
- Independently manage interactions with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
- Communicate study status, issues, and mitigations to relevant cross-functional stakeholders. Engage the input of line functions as appropriate. Lead trial level interactions with external functions (clinical sites, CROs, third party vendors) and relevant internal functions including Pharmacovigilance, Cell Procurement, CMC, QC/QA, and Supply Chain.
- Collaborate with Clinical Development, Data Management/Biostatistics, Pharmacovigilance, and other functions to ensure robust plans for trial level data review including trend evaluation.
- Train team members and site staff, including vendors, as needed
- Participate in contract and budget negotiations with clinical sites and vendors
- Develop critical study documents including informed consent forms, study conduct documents such as study manuals, study tools, subject recruitment materials, etc.; participate in development of protocols, investigator brochures, including updates and amendments
- Drive traceability procedures for investigational products and subject samples and cross functionally coordinate subject treatment forecasting and planning
- Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
- Review and approve corrective action plans at individual sites and across study, may participate in internal/external study related audits
- Perform research site activities, such as site qualification visits, site initiation visits, trainings and motivational visits, co-monitoring, close out visits, as needed
- Actively contribute in the Clinical Development Operations department to the implementation of best practices and standards for trial management, including sharing lessons learned.
- BS/BA/RN Degree in science or a health related field is preferred
- Minimum 7 years relevant industry clinical development experience, with at least 2 years of managing multi-disciplinary project teams
- Experience and understanding of global clinical trial operations, hematology and/or transplant experience welcome
- Experience with all aspects of trial and site startup and vendor management
- Familiarity with clinical data review and data management processes, including Data Monitoring Committees
- Must be able to travel up to 20%, domestically and internationally
- Strong verbal and written communication skills
- Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem solving ability is essential
- Ability to work on teams with aggressive timelines and to multi-task in a fast-paced environment with changing priorities
- Excellent knowledge of GCP, ICH and FDA regulations
- Independently motivated to learn and lead
- “Do-what-it-takes” approach to problem solving and prospective thinking
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
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.