Associate Director, Clinical Operations
4D Molecular Therapeutics
September 01, 2026
On-site
United States
Clinical Research and Development
General Summary:
The Associate Director, Clinical Operations will be responsible for implementation, execution, and oversight of all clinical trials within a clinical program, ensuring assigned trials are executed on time, within budget, and in compliance with GCP and applicable guidelines/regulations.
Major Duties & Responsibilities:
- Partner with Director of Clinical Operations to develop and manage clinical programs.
- Provide operational leadership for clinical trial planning, execution, interpretation, and data collection (timelines, budgets, risks, mitigation).
- Mentor Clinical Trial Managers (CTMs) and junior staff on study documents, vendor/study management, implementation, issue resolution, timelines, budgeting, and resourcing.
- Oversee day-to-day Clinical Trial Operations and Clinical Data Management activities.
- Collaborate with Finance/Business Operations on budgeting, re-forecasts, clinical vendor outsourcing strategy, vendor selection, and vendor governance.
- Ensure trials are always inspection-ready and managed by a cross-functional Study Execution Team (SET).
- Serve as Clinical Operations SME on product cross-functional core teams (as needed).
- Partner with Quality and Regulatory Affairs/Clinical Sciences for inspection readiness and regulatory submissions (e.g., ClinicalTrials.gov).
- Coordinate clinical SOP development/maintenance and review of cross-functional SOPs and documents.
- Support protocol/amendment and study document development and operational execution.
- Participate in CRO/site/vendor selection; provide surveillance of progress and trigger contingency plans as needed.
Qualifications:
- BS/BA in Life Science or related discipline required; advanced degree preferred.
- 9+ years clinical development experience with 3+ years managerial experience (or 4+ years with MS/MA).
- Ophthalmology/Retina experience required; clinical trial execution across all phases.
Skills (required/preferred):
- Recruit/retain/organize/motivate clinical operations personnel.
- Communicate priorities and advocate for budgets/resources.
- Develop/manage functional and trial-specific budgets.
- Knowledge of FDA/ICH/GCP and medical terminology; strong communication/presentation and writing skills.
Travel: Anticipate 20% or as trial needs demand.
The Associate Director, Clinical Operations will be responsible for implementation, execution, and oversight of all clinical trials within a clinical program, ensuring assigned trials are executed on time, within budget, and in compliance with GCP and applicable guidelines/regulations.
Major Duties & Responsibilities:
- Partner with Director of Clinical Operations to develop and manage clinical programs.
- Provide operational leadership for clinical trial planning, execution, interpretation, and data collection (timelines, budgets, risks, mitigation).
- Mentor Clinical Trial Managers (CTMs) and junior staff on study documents, vendor/study management, implementation, issue resolution, timelines, budgeting, and resourcing.
- Oversee day-to-day Clinical Trial Operations and Clinical Data Management activities.
- Collaborate with Finance/Business Operations on budgeting, re-forecasts, clinical vendor outsourcing strategy, vendor selection, and vendor governance.
- Ensure trials are always inspection-ready and managed by a cross-functional Study Execution Team (SET).
- Serve as Clinical Operations SME on product cross-functional core teams (as needed).
- Partner with Quality and Regulatory Affairs/Clinical Sciences for inspection readiness and regulatory submissions (e.g., ClinicalTrials.gov).
- Coordinate clinical SOP development/maintenance and review of cross-functional SOPs and documents.
- Support protocol/amendment and study document development and operational execution.
- Participate in CRO/site/vendor selection; provide surveillance of progress and trigger contingency plans as needed.
Qualifications:
- BS/BA in Life Science or related discipline required; advanced degree preferred.
- 9+ years clinical development experience with 3+ years managerial experience (or 4+ years with MS/MA).
- Ophthalmology/Retina experience required; clinical trial execution across all phases.
Skills (required/preferred):
- Recruit/retain/organize/motivate clinical operations personnel.
- Communicate priorities and advocate for budgets/resources.
- Develop/manage functional and trial-specific budgets.
- Knowledge of FDA/ICH/GCP and medical terminology; strong communication/presentation and writing skills.
Travel: Anticipate 20% or as trial needs demand.