Associate Director, Clinical Research-Department of Neurosurgery-GMP

Associate Director, Clinical Research

Strategic Planning & Program Leadership

• Lead development and execution of CMC strategies across cell therapy and RNA-LNP modalities in alignment with departmental and institutional priorities.
• Participate in and contribute to strategic planning for advanced therapy development programs.
• Evaluate program effectiveness and drive continuous improvement in CMC processes, infrastructure, and policies.
• Monitor emerging trends in advanced manufacturing and regulatory guidance and integrate relevant advancements into CMC planning.

Process Development & Manufacturing Innovation

• Lead adoption of automated and closed-system technologies to enhance reproducibility, scalability, and GMP compliance of cell-based therapeutic products.
• Oversee phase-appropriate process development activities from pre-clinical through late-stage clinical trials.
• Direct efficient transfer of discoveries from academic laboratories into GMP-compliant manufacturing environments.

Technology Transfer, Manufacturing Readiness & Validation

• Oversee manufacturing readiness assessments, technology transfers, and validation planning for clinical and research manufacturing activities.
• Establish, monitor, and report KPIs for process development, technology transfer, and manufacturing performance.
• Coordinate cross-functional activities to ensure compliant, timely, and efficient manufacturing operations.
• Lead the material vendors selection in compliance with regulations.

Regulatory, Quality & Clinical Integration

• Lead collaboration with Quality, Regulatory, and Clinical teams to ensure CMC deliverables support IND/IDE submissions and regulatory inspections.
• Oversee preparation for regulatory audits and ensure ongoing compliance with university, state, and federal requirements.
• Integrate evolving regulatory expectations and industry best practices into CMC execution. 10% – Team Leadership & Operations.
• Manage day-to-day operations of assigned CMC functional areas, including supervision of professional, technical, and support staff.
• Recruit, mentor, and retain a diverse, multidisciplinary CMC team.
• Establish performance goals, provide coaching and feedback, and foster a collaborative, inclusive, and mission-driven work environment.

Institutional Engagement & External Collaboration

• Lead development of strategic partnerships related to advanced therapy development and translational manufacturing.
• Represent the institution on internal committees and in external collaborations related to CMC and advanced therapeutics.
• Contribute to efforts that position the institution as a regional and national resource for advanced therapeutic development.
• Actively engage potential internal and external clients seeking GMP manufacturing services.

Salary commensurate with experience

• Experience in clinical nursing, nursing management, and clinical research in Neuro-Oncology.
• Experience in managing and coordinating a complex team of clinical research professionals in Oncology.
• EPIC Experience
• Critical thinking skills
• Previous nursing leadership and management experience required
• Nursing experience in oncology or neurology required
• Possess excellent communication and interpersonal skills
• Working knowledge of software programs Word, Excel, PowerPoint, Redcap, and Oncore

Application must be submitted by 11:55 p.m. (ET) of the posting end date.