| Classification Title: | Associate Director Clinical Research |
|---|
| Classification Minimum Requirements: | Masters degree in appropriate area of specialization and four years of appropriate experience; or a bachelors degree in appropriate areas of specialization and six years of experience. |
|---|
| Job Description: | 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.
|
|---|
| Expected Salary: | Salary commensurate with experience |
|---|
| Required Qualifications: | Masters degree in appropriate area of specialization and four years of appropriate experience; or a bachelors degree in appropriate areas of specialization and six years of experience. |
|---|
| Preferred: | - 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
|
|---|
| Special Instructions to Applicants: | 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. |
|---|
| Health Assessment Required: | Yes |
|---|
Required Experience:
Director
Classification Title:Associate Director Clinical ResearchClassification Minimum Requirements:Masters degree in appropriate area of specialization and four years of appropriate experience; or a bachelors degree in appropriate areas of specialization and six years of experience.Job Description:Strateg...
| Classification Title: | Associate Director Clinical Research |
|---|
| Classification Minimum Requirements: | Masters degree in appropriate area of specialization and four years of appropriate experience; or a bachelors degree in appropriate areas of specialization and six years of experience. |
|---|
| Job Description: | 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.
|
|---|
| Expected Salary: | Salary commensurate with experience |
|---|
| Required Qualifications: | Masters degree in appropriate area of specialization and four years of appropriate experience; or a bachelors degree in appropriate areas of specialization and six years of experience. |
|---|
| Preferred: | - 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
|
|---|
| Special Instructions to Applicants: | 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. |
|---|
| Health Assessment Required: | Yes |
|---|
Required Experience:
Director
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Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
