Head, Clinical Development Operations

About The Nest

The nest is a place where 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 gig, you become part of a flock 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 The Flock

The Head of Clinical Development Operations (CDO) (Senior Director/ Vice President) is responsible for leading the CDO organization in development strategy and operations. In this role, you will oversee development operations functions including Clinical Trial Strategy and Execution and Vendor Governance. You will be accountable for budget planning, resource management, innovation, and process improvement and for identifying and mitigating risks for development operations activities across the company’s portfolio.

How You’ll Fly

You’ll help to bring more patients their bluebird days by:

• Providing leadership, strategic oversight, and guidance to CDO staff to ensure quality, timeline, resources, and budget goals are met
• Participating in and contributing to cross-functional strategic discussions pertaining to the clinical development plan and study protocols
• Effectively interacting with senior members in other functional areas for strategic planning to ensure optimized clinical development operations in accordance with corporate objectives
• Ensuring high standards in clinical activities for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards
• Representing CDO and providing updates to the Executive Team, Project Teams, and other key stakeholders
• Providing support for regulatory submissions including timeline planning, data preparation, document review, inspection readiness, post-submission queries, and advisory committees
• Providing guidance to CTSE staff in support of clinical trial and registry study execution, biometrics staff in support of study design and analysis, data management staff in support of data collection and review
• Providing strategic oversight in the selection, management and governance of clinical trial/registry study vendors
• Leading change in the organization to continuously adapt to a dynamic and growth environment
  
  

What You’ll Bring

You’re the bird we’re looking for if you have:

• Bachelor’s degree minimally required. Advanced degree such as MS, MBA, MPH or PhD highly preferred
• 12+ years of clinical development experience in biotech or pharmaceutical industry
• Experience in gene therapy or rare disease preferred
• Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of FDA and EMA Regulations and ICH Guidelines
• Extensive experience across all phases of clinical trials and registry studies
• Experience in developing SOPs and building infrastructure
• Strong cross functional leadership skills; demonstrated ability to lead, manage performance, mentor and build development operations teams
• Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work
• Excellent oral and written communication skills, including the ability to present information and lead effective meetings
  
  

Compensation & Benefits

We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $240,000 - $285,000. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as paid holidays, bluebird days, and a holiday shutdown in December.

bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

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.