General Summary
The Associate Director, Clinical Operations will oversee implementation, execution, and oversight of clinical trials within a clinical program to ensure trials are on time, within budget, and compliant with GCP and applicable guidelines/regulations.
Major Duties & Responsibilities
- Partner with Director of Clinical Operations to develop/manage clinical programs aligned to corporate objectives and timelines.
- Provide operational leadership for trial planning, execution, and interpretation; develop/monitor timelines, budgets, risks, and mitigation plans.
- Mentor Clinical Trial Managers (CTMs) and junior staff on study documents, vendor/study management, implementation, issue resolution, timelines, budgeting, and resourcing.
- Independently oversee day-to-day Clinical Trial Operations and Clinical Data Management.
- Collaborate with Finance/Business Operations on budgeting, re-forecasts, clinical vendor outsourcing strategy, vendor selection, and vendor governance.
- Ensure trials are inspection ready; ensure active management via cross-functional Study Execution Team (SET).
- Serve as Clinical Operations SME on product core teams; partner with Quality for inspection readiness.
- Collaborate with Regulatory Affairs/Clinical Sciences on regulatory submissions (e.g., ClinicalTrials.gov).
- Lead/escalate issue resolution and risk mitigation; coordinate clinical SOP development and review of protocols/amendments.
- Participate in CRO/site/vendor selection and maintain partner alignment; trigger contingency plans as needed.
Qualifications
- B.S./B.A. in Life Science or related (required); advanced degree preferred.
- Clinical research certification preferred (not required).
- B.S./B.A.: 9+ years clinical development with 3+ years management, or M.A./M.S.: 4+ years.
- Ophthalmology/Retina experience required.
- Experience executing clinical trials across all phases.
Skills (Required/Preferred)
- Recruit/retain/organize/lead clinical operations personnel; communicate priorities and resource needs.
- Manage budgets; self-motivated, detail-oriented; strong interpersonal and communication skills.
- Knowledge of FDA/ICH/GCP and medical terminology; flexibility/adaptability; ability to write and present complex information.
Travel
- Anticipate 20% (or as trial needs demand).
Compensation
- Base salary compensation range: $179,000β$196,000.