bluebird bio

Compensation

Full Description

About bluebird bio At bluebird every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values: Persist for Purpose Be Compassionate Stay humble and curious Keep it real Celebrate (sm)all wins Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. ABOUT US Responsible for overseeing all aspects of clinical study management for a gene therapy product. Able to successfully manage one or more complex studies with minimal supervision. Responsibilities include study planning and execution, timelines, budget, clinical site and vendor management. Comfortable working independently, managing interactions with experienced clinical monitors and cross-functional internal/external project stakeholders. RESPONSIBILITIES Responsible for assigned clinical trials being managed to the highest Responsible for all aspects of study planning and execution (in support of Regulatory filings), such as timelines, budget, team management, and vendor oversight, with a focus on inspection Oversee financial aspects of the study. Accountable for the performance and delivery of all trial activities, including oversight and management of complex, cross-functional study level issues. Value, promote and recognize performance achieved through teamwork and Presents work to cross-functional groups/ committees when requested. Makes study level decisions and drives difficult team or vendor discussions to resolution, understanding when to pull in relevant stakeholders. Manages multiple tasks and resolves competing priorities. Lead cross-functional teams or workstreams with a meaningful impact on critical Point of escalation for study teams: Works with cross-functional partners and vendors to discuss issues, develop solutions, follow through resolution, and implement process improvements. Proactively communicates complex and sensitive study information or issues and understands stakeholder impact. Independently navigates complex issues that hold major impact on the program. Lead and own formal risk assessment activities, contingency planning, escalation, and approve corrective action plans. Assist the CRA team when issues arise or deliverables are at risk. Execute on study data Review study data, communicate study status, risks, and issues effectively both internally and with outsourced partners. Implement new processes and procedures per SOPs and regulations/guidance. Present to cross-functional Present supportive arguments by framing, positioning and timing messages appropriately to the audience. Convey confidence when presenting. Formulate logical responses to questions. Written communications are succinct, streamlined and logical. Coach for high performance. Participate effectively as a leader. Proactively promote the exchange of ideas, information and feedback. Positive role model for Possess a broad understanding of cross-functional issues and challenges along with ability to engage in productive debate to enable effective solutions that address CTSE issues and challenges. Handle conflict sensitively and quickly. Clinical Subject Matter Expert for internal/external audits and agency (what does this mean?) Prioritize relationship management between Study Investigators/staff, vendors, Partner with cross- functional team members to foster these external relationships. Seek opportunities to present May present at external conference. Add value to study publications, attend conferences to build stakeholder Travel (domestic and international) may be QUALIFICATIONS Bachelor’s degree, in a life science Minimum 7 years clinical experience (biopharma, CRO, healthcare), with at least 2 years of managing cross- functional project teams. Monitoring experience preferred. Expert knowledge & breadth of expertise in all technical aspects of managing global clinical trials and overseeing cross-functional study teams with a proven track record. Experience troubleshooting situations of non- Proven ability to identify study priorities, key stakeholders, define goals, and drive/achieve results through a cross- functional study team. Connect study deliverables to a comprehensive timeline and budget. Deep understanding of how study decisions, challenges, and achievements impact the overall Proven compliance with FDA & EU regulations, ICH/GCP, experience working in other Experience with BLA submissions, regulatory agency inspections preferred. Familiarity with clinical data review and data management processes, including Data Monitoring Committees Strong verbal and written communication Ability to work on teams with aggressive timelines and to multi-task in an extremely fast-paced and dynamic environment with changing priorities. Independently motivated to learn and lead with minimal direction Detail oriented. “Do-what-it-takes” approach to problem solving, creative 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 bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.