VICE PRESIDENT, DEVELOPMENT OPERATIONS

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:

The Vice President, Development Operations will hire, lead, mentor, and scale the Development Operations organization, ensuring the successful execution of all clinical development activities in alignment with corporate strategy. This includes building the infrastructure, systems, and processes that enable our clinical trials to be delivered with quality, compliance, and efficiency. This role reports to the Chief Development Officer.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

QUALIFICATIONS

• Bachelor’s degree in a scientific or health-related field required; advanced degree preferred.
• 15+ years of experience in Development Operations, with 6+ years in a leadership capacity.
• Demonstrated success in building and leading Development Operations functions in oncology (rare disease or pediatric oncology experience highly desirable).
• Proven track record in global trial execution including late-stage/registrational studies.
• Expertise in vendor governance, CRO oversight, systems implementation, and inspection readiness.
• Robust knowledge of ICH/GCP, FDA/EMA regulations, and global compliance frameworks.
• Effective collaborator with strong relationship-building skills across internal and external partners.
• Proven ability to anticipate challenges, proactively mitigate risks, and solve problems.
• Flexible and resourceful, thriving in a dynamic biotech environment.
• Strong organizational and communication skills; able to set clear priorities and deliver results.
• Ability to travel.
  The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

• Provide strategic leadership for Development Operations across the portfolio, ensuring programs are executed in accordance with the drug development plan, global strategy, and corporate goals.
• Oversee core development operations functions beyond day-to-day study execution, including vendor governance, inspection readiness, clinical systems, and trial master file (TMF) integrity.
• Ensure operational consistency across programs, regions, and development phases.
• Lead workforce planning, team training, retention, and performance management.
• Build and optimize systems, policies, SOPs, and quality frameworks to support trial execution and regulatory compliance (ICH/GCP, FDA, EMA, and global guidelines).
• Partner cross-functionally with Clinical Development, Regulatory, Biometrics, Pharmacovigilance, Quality Assurance, Finance, IT, and Medical Affairs to ensure seamless program delivery.
• Direct vendor oversight strategy, including selection, contracting, performance monitoring, and escalation management, ensuring high-quality deliverables on budget and timeline.
• Lead proactive identification, assessment, and mitigation of risks across clinical programs.
• Own inspection and audit readiness for Development Operations, ensuring documentation, systems, and processes stand up to regulatory scrutiny.
• Contribute to strategic planning, budget forecasting, and long-range corporate goals as part of the Development leadership team.
• Other duties as assigned.