Associate Director, Clinical Research-Department of Neurosurgery-GMP

Associate Director, Clinical Research-Department of Neurosurgery-GMP

Job No: 539033
Work Type: Full Time
Location: Main Campus (Gainesville, FL)
Categories: Office/Administrative/Fiscal Support, Grant or Research Administration
Department:  - MD-NEUROLOGICAL SURGERY

Classification

Title:

Associate Director, Clinical Research

Classification

Minimum 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.

• 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. 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.

• 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

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.

• 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

For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.

The University of Florida is an Equal Employment Opportunity Employer.

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

Yes

16 March 2026

(Use the "Apply for this Job" box below)./539033

The University of Florida is an Equal Employment Opportunity Employer.

The University of Florida is a public institution and is subject to all requirements under Florida Sunshine and Public Record laws. If an accommodation due to a disability is needed to apply for this position, please call 352‑392‑2477 or the Florida Relay System at 800‑955‑8771 (TDD) or visit Accessibility at UF.