Associate Director, Clinical Operations
4D Molecular Therapeutics
June 24, 2026
Remote friendly (United States)
United States
Clinical Research and Development
GENERAL SUMMARY:
The Associate Director, Clinical Operations will implement, execute, and oversee clinical trials within a clinical program, coordinating with cross-functional teams to ensure trials are executed on time, within budget, and in compliance with GCP and applicable regulations.
MAJOR DUTIES & RESPONSIBILITIES:
- Partner with Director of Clinical Operations to develop/manage clinical programs aligned with corporate objectives and timelines.
- Provide operational leadership for trial planning, execution, data collection interpretation; develop/monitor timelines, budgets, risks, and mitigation plans.
- Guide/mentor Clinical Trial Managers (CTMs) and junior team members on study documents, vendor/study management, implementation, issue resolution, timelines, budgeting, and resourcing.
- Oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management.
- Collaborate with Finance/Business Operations on budget planning, quarterly reviews/re-forecasts; design/oversee vendor outsourcing strategy; support vendor selection and governance.
- Ensure trials are inspection ready; ensure active management by a cross-functional Study Execution Team (SET).
- Serve as Clinical Operations SME on product cross-functional core teams.
- Partner with Quality for inspection readiness.
- Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions (e.g., ClinicalTrials.gov) and compliance.
- Address escalated study issues with CTMs and senior management; coordinate risk mitigation.
- Coordinate development/maintenance of clinical SOPs and contribute to cross-functional SOPs.
- Support protocol/amendment and study document/plans development and operational execution.
- Participate in CRO/site/vendor selection; ensure delegated responsibilities and partner alignment; monitor progress and trigger contingency plans.
- Contribute to Clinical Operations processes/procedures and manage clinical resources for effective trial implementation.
QUALIFICATIONS:
Education:
- B.S./B.A. in Life Science or related discipline required.
- Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
- Clinical Research certification preferred (not required).
Experience:
- B.S./B.A.: 9+ years clinical development experience with 3+ years managerial experience; or M.A./M.S.: 4+ years.
- Late-phase trial experience required; clinical trial execution across all phases.
Other Skills/Requirements:
- Recruit/retain/organize/motivate clinical operations personnel.
- Communicate priorities/updates; advocate for budgets/resources.
- Manage programs with corporate-wide impact; develop/manage budgets.
- Self-motivated; prioritize large workload; attention to detail.
- Strong interpersonal skills; partner across functions.
- Thorough FDA/ICH/GCP knowledge; medical terminology; ability to write and present complex information.
- Flexible/adaptable to changing needs.
Travel: Anticipate 20%.
Base salary range: $179,000 - $196,000.
The Associate Director, Clinical Operations will implement, execute, and oversee clinical trials within a clinical program, coordinating with cross-functional teams to ensure trials are executed on time, within budget, and in compliance with GCP and applicable regulations.
MAJOR DUTIES & RESPONSIBILITIES:
- Partner with Director of Clinical Operations to develop/manage clinical programs aligned with corporate objectives and timelines.
- Provide operational leadership for trial planning, execution, data collection interpretation; develop/monitor timelines, budgets, risks, and mitigation plans.
- Guide/mentor Clinical Trial Managers (CTMs) and junior team members on study documents, vendor/study management, implementation, issue resolution, timelines, budgeting, and resourcing.
- Oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management.
- Collaborate with Finance/Business Operations on budget planning, quarterly reviews/re-forecasts; design/oversee vendor outsourcing strategy; support vendor selection and governance.
- Ensure trials are inspection ready; ensure active management by a cross-functional Study Execution Team (SET).
- Serve as Clinical Operations SME on product cross-functional core teams.
- Partner with Quality for inspection readiness.
- Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions (e.g., ClinicalTrials.gov) and compliance.
- Address escalated study issues with CTMs and senior management; coordinate risk mitigation.
- Coordinate development/maintenance of clinical SOPs and contribute to cross-functional SOPs.
- Support protocol/amendment and study document/plans development and operational execution.
- Participate in CRO/site/vendor selection; ensure delegated responsibilities and partner alignment; monitor progress and trigger contingency plans.
- Contribute to Clinical Operations processes/procedures and manage clinical resources for effective trial implementation.
QUALIFICATIONS:
Education:
- B.S./B.A. in Life Science or related discipline required.
- Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
- Clinical Research certification preferred (not required).
Experience:
- B.S./B.A.: 9+ years clinical development experience with 3+ years managerial experience; or M.A./M.S.: 4+ years.
- Late-phase trial experience required; clinical trial execution across all phases.
Other Skills/Requirements:
- Recruit/retain/organize/motivate clinical operations personnel.
- Communicate priorities/updates; advocate for budgets/resources.
- Manage programs with corporate-wide impact; develop/manage budgets.
- Self-motivated; prioritize large workload; attention to detail.
- Strong interpersonal skills; partner across functions.
- Thorough FDA/ICH/GCP knowledge; medical terminology; ability to write and present complex information.
- Flexible/adaptable to changing needs.
Travel: Anticipate 20%.
Base salary range: $179,000 - $196,000.