Director, Clinical Operations - AAV
Rocket Pharmaceuticals
June 30, 2026
Remote friendly (Cranbury, NJ)
United States
Operations
Position Summary:
Director, Clinical Operations – AAV (reports to VP, Clinical Operations) provides strategic oversight and operational execution of the Clinical Operations function for AAV programs in the Rocket portfolio, including planning, initiating, supervising, and completing clinical research studies for rare genetic diseases.
Responsibilities:
- Single point of accountability for Clinical Operations strategy and execution of deliverables within study budgets/timelines/quality standards in AAV Global Program Teams (GPTs); share risks/opportunities; collaborate and communicate with team members and GPH/PM.
- Provide operational and strategic input during clinical trial planning: clinical planning tools, protocol review, CRF development/review, operational manuals, oversight of study-specific eTMF plans, training materials, trial plans (monitoring, risk mitigation, communication), and budget planning.
- Oversee clinical monitoring and site activities to ensure GCP and regulatory compliance; manage site qualification, initiation, interim monitoring, and closeout; participate in visits as needed.
- Manage CRO-related monitoring trip reports process and ensure resolution of CRO action items.
- Provide trial status updates and potential issues/mitigation to AAV leadership and Head of Clinical Operations.
- Manage clinical vendors (CROs, labs, imaging vendors); ensure compliance; oversee RFP, contract/budget preparation, negotiations, and vendor oversight across the trial lifecycle.
- Develop study-specific communication pathways/processes for site logistics (contracts, support materials/training, IRB/EC process).
- Direct cross-functional Study Operations teams; ensure appropriate dissemination of study information and oversee relevant meetings.
- Lead quality review and reconciliation of study documents; oversee site regulatory documents/packages review; develop/oversee site budgets and investigator/vendor payment processes.
- Support Clinical Operations leadership initiatives (process streamlining, SOP development, mentoring and developing Clinical Trial Managers/Clinical Research Associates).
- Lead cross-functional review/escalation of clinical data listings for completeness/accuracy.
- Ensure study teams and sites have proper study management tools.
- Coordinate with CQA for inspection readiness; manage audit/inspection follow-up, commitments, CAPA implementation.
- Represent Clinical Operations in regulatory agency inspections.
Qualifications:
- Bachelor’s degree in health care/life sciences or related field (preferred).
- 12+ years clinical trial experience in pharma/biotech/CROs/healthcare research; 8+ years managing clinical trial programs (start-up through close-out), preferably global; manage Clinical Trial Managers and Clinical Research Associates.
- Gene therapy and rare/orphan disease experience (highly desired).
- Regulatory filings (NDA/BLA/MAA) and health authority inspections (highly desired).
- Deep knowledge of Clinical Development process and global regulatory/compliance requirements (ICH/GCP, 21 CFR, and applicable regulations).
- Advanced project management skills (schedule, budget, communication, resources, quality); experience developing SOPs/procedures/policies.
- Strong stakeholder relationship management; lead cross-functional teams in a matrix environment.
- Medidata RAVE and Veeva CTMS, eTMF & QMS experience (highly desired).
- Proficient in MS Office; SharePoint; global experience.
- Travel: ~10–20%.
Compensation/Benefits:
- Expected salary range: $196,000–$261,000.
- Total rewards may include bonuses, medical/dental/vision, life insurance, 401(k) with company match and generous vesting, paid vacation/holidays, global shutdown days (between Christmas and New Year’s), wellness resources/employee support; equity awards for eligible positions.
Director, Clinical Operations – AAV (reports to VP, Clinical Operations) provides strategic oversight and operational execution of the Clinical Operations function for AAV programs in the Rocket portfolio, including planning, initiating, supervising, and completing clinical research studies for rare genetic diseases.
Responsibilities:
- Single point of accountability for Clinical Operations strategy and execution of deliverables within study budgets/timelines/quality standards in AAV Global Program Teams (GPTs); share risks/opportunities; collaborate and communicate with team members and GPH/PM.
- Provide operational and strategic input during clinical trial planning: clinical planning tools, protocol review, CRF development/review, operational manuals, oversight of study-specific eTMF plans, training materials, trial plans (monitoring, risk mitigation, communication), and budget planning.
- Oversee clinical monitoring and site activities to ensure GCP and regulatory compliance; manage site qualification, initiation, interim monitoring, and closeout; participate in visits as needed.
- Manage CRO-related monitoring trip reports process and ensure resolution of CRO action items.
- Provide trial status updates and potential issues/mitigation to AAV leadership and Head of Clinical Operations.
- Manage clinical vendors (CROs, labs, imaging vendors); ensure compliance; oversee RFP, contract/budget preparation, negotiations, and vendor oversight across the trial lifecycle.
- Develop study-specific communication pathways/processes for site logistics (contracts, support materials/training, IRB/EC process).
- Direct cross-functional Study Operations teams; ensure appropriate dissemination of study information and oversee relevant meetings.
- Lead quality review and reconciliation of study documents; oversee site regulatory documents/packages review; develop/oversee site budgets and investigator/vendor payment processes.
- Support Clinical Operations leadership initiatives (process streamlining, SOP development, mentoring and developing Clinical Trial Managers/Clinical Research Associates).
- Lead cross-functional review/escalation of clinical data listings for completeness/accuracy.
- Ensure study teams and sites have proper study management tools.
- Coordinate with CQA for inspection readiness; manage audit/inspection follow-up, commitments, CAPA implementation.
- Represent Clinical Operations in regulatory agency inspections.
Qualifications:
- Bachelor’s degree in health care/life sciences or related field (preferred).
- 12+ years clinical trial experience in pharma/biotech/CROs/healthcare research; 8+ years managing clinical trial programs (start-up through close-out), preferably global; manage Clinical Trial Managers and Clinical Research Associates.
- Gene therapy and rare/orphan disease experience (highly desired).
- Regulatory filings (NDA/BLA/MAA) and health authority inspections (highly desired).
- Deep knowledge of Clinical Development process and global regulatory/compliance requirements (ICH/GCP, 21 CFR, and applicable regulations).
- Advanced project management skills (schedule, budget, communication, resources, quality); experience developing SOPs/procedures/policies.
- Strong stakeholder relationship management; lead cross-functional teams in a matrix environment.
- Medidata RAVE and Veeva CTMS, eTMF & QMS experience (highly desired).
- Proficient in MS Office; SharePoint; global experience.
- Travel: ~10–20%.
Compensation/Benefits:
- Expected salary range: $196,000–$261,000.
- Total rewards may include bonuses, medical/dental/vision, life insurance, 401(k) with company match and generous vesting, paid vacation/holidays, global shutdown days (between Christmas and New Year’s), wellness resources/employee support; equity awards for eligible positions.