Director, Regulatory Affairs

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology's mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.

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.