Head, Clinical Development Operations

ABOUT THE FLOCK

Head of Clinical Development Operations (CDO) (Senior Director/ Vice President) is responsible for leading the CDO organization in development strategy and operations. This individual will oversee development operations functions including Clinical Trial Strategy and Execution and Vendor Governance. He/she is 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:
• Provide leadership, strategic oversight, and guidance to CDO staff to ensure quality, timeline, resources, and budget goals are met
• Participate in and contribute to cross-functional strategic discussions pertaining to the clinical development plan and study protocols
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development operations in accordance with corporate objectives
• Ensures high standards in clinical activities for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards
• Represents CDO and provides updates to the Executive Team, Project Teams, and other key stakeholders
• Provides support for regulatory submissions including timeline planning, data preparation, document review, inspection readiness, post-submission queries, and advisory committees
• Provides 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
• Provides strategic oversight in the selection, management and governance of clinical trial/registry study vendors
• Leads 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
• Ability to work collaboratively as part of a cross-functional development team in a dynamic environment
• 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
• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

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.