Director, Clinical Trial Strategy & Execution

About Genetix Biotherapeutics

At Genetix every role has meaning, every team member is respected. When you join Genetix Biotherapeutics, 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 and better 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

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.

Responsibilities

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.

• Full strategic responsibility and accountability for oversight of CTSE Program function and overall program
• 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
• Ultimately responsible for program execution, inspection readiness and
• Deep oversight of vendor and site budgets, including negotiating to ensure efficient use of company resources.
• 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.
• 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.
• Provide guidance and delegation to team and peers on complex issues, change management, and decision
• 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
  
  

Qualifications

• Bachelor's degree, in a life science Advanced degree is a plus.
• Minimum 12 years clinical experience (biopharma, CRO, healthcare), with at least 5 years of managing cross- functional project teams. Monitoring experience preferred.
• Proven expertise and success in overseeing clinical trials and managing a clinical program, including setting operational strategy for the clinical development of a product.
• 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.
• Proven compliance with FDA & EU regulations, ICH/GCP, experience working in other Experience with BLA submissions, regulatory agency inspections preferred.
• Recognized by peers as an influential thought-leader within former and current
• Strong verbal and written communication skills
  
  

Genetix 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.