Associate Director, Clinical Research-Department of Neurosurgery-GMP

University of Florida•Gainesville, FL

About The Position

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.

Requirements

Master's degree in appropriate area of specialization and four years of appropriate experience; or a bachelor's degree in appropriate areas of specialization and six years of experience.

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.