Associate Director, Clinical Operations
About the role
The Associate Director, Clinical Operations will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech.
Essential Functions And Responsibilities
- Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials.
- Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
- Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.
- Manage, mentor, and support direct reports, fostering professional development and team performance.
- Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection.
- Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.
- Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.
- Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).
- Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
- Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.
- Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.
- Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.
- Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.
Benefits
- Annual bonus program
- Incentive stock option plan
- 401k plan with flat non-elective employer contribution
- Comprehensive medical insurance with 90-100% employer-paid premiums
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Generous holiday schedule; includes summer and winter company shutdown
- Relocation assistance
Schedule
Monday to Friday
Work Location
On site (San Diego, CA)
Additional Compensation
Annual targeted bonus %
Work Authorization
United States (Required)
Base Salary Range
Ranging from $175,000 to $200,000
Additional Information
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.