<p>ABOUT US</p> <p>The Director of Clinical Trial Strategy & Execution (CTSE) is a member of the Clinical Development Operation functional team. CTSE is an integrated and diverse team that advances and optimizes the strategic design, development and execution of bluebird bio's clinical research studies program (Long-Term Follow-up, Phase III & Phase IV studies). We are committed to operational excellence and inspired by the patients and families who participate in our programs.</p> <p>RESPONSIBILITIES</p> <p>The Director, Clinical Trial Strategy & Execution, will provide strategic leadership and oversight of several clinical studies, leveraging resources, expertise and knowledge across programs in various stages.</p> <ul> <li>Full strategic responsibility and accountability for oversight of CTSE Program function and overall program </li><li>With minimal supervision, defines program deliverables, proactively creates long range internal/external resource plans for the program and ensures resource allocation is appropriate against fluctuating </li><li>Ultimately responsible for program execution, inspection readiness and </li><li>Identify gaps and strengthen cross-functional communication and accountability, develop and implement long- term solutions for best working practices and assist with application to other programs. </li><li>Synthesize deep understanding of regulations, ICH/GCP, and bluebird processes, to identify program risks, challenges, and Proactively drive discussions with the appropriate stakeholders to resolution, minimizing the need for escalation. </li><li>Provide guidance to team and peers on complex issues, change management, and decision </li><li>Leverage talent and collaborate with CTSE peers to creatively shift resources to deliver on urgent program priorities. Provide opportunities for training, development, and mentorship of team members. </li></ul> <p>QUALIFICATIONS</p> <ul> <li>Bachelor's degree, in a life science Advanced degree is a plus. </li><li>Minimum 12 years clinical experience (biopharma, CRO, healthcare), with at least 5 years of managing cross- functional project teams. Monitoring experience preferred. </li><li>Proven expertise and success in overseeing clinical trials and managing a clinical program, including setting operational strategy for the clinical development of a product. </li><li>Experience leading clinical functions and achieving program 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. </li><li>Proven compliance with FDA & EU regulations, ICH/GCP, experience working in other Experience with BLA submissions, regulatory agency inspections preferred. </li><li>Recognized by peers as an influential thought-leader within former and current </li><li>Strong verbal and written communication skills </li></ul>