The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. 

We are hiring for a Senior Director, Regulatory Operations – Phase 1 Oncology Site. The Regulatory Operations leader ensures that all regulatory documentation, submissions, approvals, essential documents, safety communications, and regulatory workflows for Phase 1 oncology studies are executed accurately, completely, and on time. This role owns the operational performance that keeps the site eligible, inspection-ready, and aligned with regulatory requirements across the US and EU.

Essential Responsibilities

Strategic Operational Vision & Execution

• Global Regulatory Operations Execution: Build and run scalable regulatory operations processes that align with site growth and evolving sponsor/IRB/EC requirements across US and EU environments.
• Cross-Functional Operational Alignment: Ensure regulatory processes, timelines, and documentation requirements are embedded seamlessly into clinical operations workflows and study startup.
• Regulatory Intelligence Routing: Monitor upcoming regulatory operational changes (IRB/EC formatting rules, CTR operational updates, submission platform changes) and ensures internal teams are updated and aligned. 

Operational Excellence in Regulatory Execution

• Submission Management: Own all operational aspects of regulatory submissions.
• Document Control Mastery: Maintain complete, audit-ready essential documents for all studies; ensures proper version control, filing integrity, approval tracking, and delegation documentation.
• Inspection & Audit Readiness (Operational Contribution): Ensure all regulatory materials are current, accurate, and immediately inspection-ready for FDA, EMA/NCA, sponsor, and IRB/EC audits.
• Regulatory Workflow Optimization: Streamline routing, approval, and communication processes to reduce delays and eliminate failure points in submissions and document updates.
• Technology Enablement: Implement and manage regulatory operations platforms (Veeva, eReg/eDOA systems, CTMS integrations, eBinder tools) to support scale and multi-site expansion.
  Leadership & Team Development

Operational Leadership:

• Lead a Regulatory Operations team responsible for document management, submissions coordination, regulatory file maintenance, and communication routing.
• Training & Competency within Reg Ops: Ensure regulatory operations staff are fully trained on submission systems, documentation standards, EU/US operational requirements, and inspection-readiness practices.
• Continuous Improvement: Creates a culture of disciplined execution, accountability, and high operational standards.

Stakeholder Coordination & Communication

• Primary Operational Regulatory Point of Contact:
  • Serve as the central liaison for investigators, study coordinators, clinical operations, sponsors, CROs, and IRBs/ECs regarding submission timelines, documentation requirements, and regulatory file status.
  • Ensure clear, timely, and proactive updates to internal teams on submission progress, approvals, expirations, and regulatory operational risks.
     

Required Education and Experience:

• Bachelor’s degree in life sciences, public health, regulatory affairs, or related field (advanced degree optional but helpful).
• 5–10 years of Regulatory Operations experience within clinical research (oncology Phase 1 strongly preferred).
• Proven experience managing IRB/EC submissions, essential documents, and inspection readiness.
• Deep understanding of ICH-GCP, IRB/EC submission requirements, essential document management, eReg/Veeva, and regulatory document control principles.
• Familiarity with 21 CFR Parts 50/56/312 and EU CTR operational processes.
   

Preferred Education and Experience:

• Experience with multi-country or EU CTR documentation workflows highly valued.
   

Best-in-Class Benefits and Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance options provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Company-paid life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided

Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.