Job Description:

The Director, Regulatory Affairs provides strategic and operational leadership for all regulatory functions across the OneOncology research network. This role serves as the central regulatory authority for a growing portfolio of industry-sponsored clinical trials, ensuring consistent compliance with FDA regulations, GCP, ICH guidelines, IRB requirements, and OneOncology's internal standards across all practice partner sites. The successful candidate will build and lead a high-performing central regulatory team, partner closely with site-level regulatory staff, and serve as a key strategic advisor to VP Research and senior leadership on regulatory risk, readiness, and innovation.

Responsibilities:

Strategic Regulatory Leadership
• Develop and operationalize the network-wide regulatory strategy, SOPs, policies, and governance framework.
• Serve as a subject matter expert (SME) for FDA regulations and applicable state regulations as it pertains to research regulatory affairs.
• Monitor evolving FDA guidance, NIH policy, and industry best practices; proactively adapt network processes.
• Represent OneOncology in sponsor/CRO regulatory meetings, audits, and pre-submission interactions.
• Advise VP Research and executive leadership on regulatory risk, resourcing gaps, and portfolio readiness.

Site Activation & Study Start-Up Oversight
• Oversee central regulatory activities that drive site activation speed: IRB submissions, essential documents, regulatory binder setup, and eTMF configuration.
• Establish and enforce network-wide start-up timeline standards; own cycle time metrics from feasibility through first patient in (FPI).
• Partner with Research Operations and Budgets & Contracts to align regulatory, legal, and financial start-up workstreams.
• Review and approve protocol-specific regulatory plans for complex, multi-arm, or early-phase trials.

Central Regulatory Team Management
• Hire, develop, and manage the OneR central regulatory team.
• Define roles, performance standards, and career pathways for central regulatory staff. • Implement workload management and capacity planning tools to ensure adequate coverage across the growing trial portfolio.
• Foster a culture of continuous improvement, collaboration, and regulatory excellence.

Site Regulatory Oversight & Support
• Provide functional oversight and guidance to site-level regulatory leads across all OneOncology partner practices.
• Conduct site regulatory assessments at new practice partners; develop onboarding plans and readiness checklists.
• Review site RACI compliance and regulatory metrics; identify and address performance gaps via CAPAs.
• Serve as escalation point for complex regulatory questions, deviations, IRB issues, and sponsor disputes.

Compliance & Audit Readiness
• Maintain audit-ready regulatory files (site eTMF and central eTMF) across all active and closed trials.
• Report regulatory compliance metrics to VP Research and Research Operations leadership monthly.
• Develop and deliver GCP, regulatory, and protocol-specific training programs for site and central staff.
• Ensure all investigational staff maintain required certifications (GCP, IATA as applicable, protocol training).
• Build a regulatory knowledge library and onboarding curriculum for new site and central regulatory staff.

Technology & Process Innovation
• Champion adoption of regulatory technology platforms (eTMF, eISF, CTMS integration) to increase efficiency and visibility.
• Lead process improvement initiatives targeting start-up cycle time reduction and audit-readiness automation.
• Collaborate with IT and data teams to develop regulatory dashboards and reporting infrastructure.
• Additional responsibilities as assigned to help drive our mission of improving the lives of everyone living with cancer.

Required or Preferred Qualifications:

Required Qualifications:
• Bachelor's degree (Master's preferred)
• Minimum 8 years of regulatory affairs experience in clinical research; 3+ years in oncology
• 3+ years managing regulatory staff in a multi-site or network setting
• Deep knowledge of FDA 21 CFR Parts 50, 54, 56, 312; ICH E6(R3) GCP; and sIRB platforms

(WCG, Advarra, NCI CIRB)
• Demonstrated experience leading IRB submissions, TMF/eTMF management, and audit preparation
• Experience with eTMF platforms (Veeva Vault, Complion, or equivalent)
• Proven ability to build processes and infrastructure from the ground up in a growing organization
• Exceptional written and verbal communication skills; comfortable presenting to executives and sponsors

Preferred / Distinguishing Qualifications:
• RAC (Regulatory Affairs Certification) from RAPS or SOCRA/ACRP certification • Experience in a community oncology research network (e.g., US Oncology, ION, SCRI, McKesson)
• Experience in early-phase (Phase I/II) oncology trials including IND-held studies • Exposure to decentralized/hybrid clinical trial regulatory considerations
• Working knowledge of CTMS platforms (OnCore, Medidata, RealTime CTMS)
• Experience developing regulatory metrics dashboards and cycle-time reporting • Strong change management skills in a matrixed, multi-site organization

Essential Competencies:
• Attendance is an essential job function.
• Regulatory Mastery: Commands deep, current knowledge of FDA regulations, GCP, and IRB

requirements; credible to sponsors, auditors, and site staff.
• Strategic Thinking: Translates regulatory risk into network-level strategy; anticipates regulatory changes

and prepares the organization proactively.
• People Leadership: Builds and retains high-performing teams; develops talent at both central and site

levels through coaching and clear expectations.
• Cross-Functional Partnership: Works seamlessly with Research Operations, Contracts, IT, and

Practice Partners to align regulatory workflows with business goals.
• Operational Excellence: Designs scalable, audit-ready processes; driven by metrics and committed to

continuous cycle time improvement.
• Communication & Influence: Communicates complex regulatory issues clearly to non-regulatory

stakeholders; builds trust with sponsor partners and site PI communities.

What Success Looks Like - First 12 Months
• 0-90 Days: Complete a regulatory capability assessment across all partner practices; map current RACI against this framework; identify top 3 gaps, identify team structure for scale and rapid growth.
• 90-180 Days: Publish updated network regulatory SOPs; implement or optimize eTMF platform; establish regulatory metrics dashboard.
• 180-365 Days: Achieve measurable reduction in average site activation time (regulatory workstream); zero regulatory-related critical findings in sponsor audits.
• Year 1+: Build and lead a scalable central regulatory team that supports 2x portfolio growth without proportional headcount increase.