Director, Drug Safety Operations

Director, Drug Safety Operations

Location: Alameda, CA or King of Prussia, PA

Summary: Oversee all aspects of drug safety study operations from start-up to close-out. Manage case workload distribution, coordinate multiple safety projects, and liaise with partners and cross-functional teams.

Key Responsibilities:

• Collaborate with stakeholders (Clinical Development, Operations, Data Management, Medical Affairs, Regulatory Affairs) for safety data collection and handling.
• Liaise with Drug Safety vendors and partners to meet global regulatory requirements for SAE reporting.
• Develop/update SOPs for safety data collection in line with regulations and ICH standards.
• Coordinate workload distribution with the Drug Safety Workflow Manager.
• Ensure proper scheduling of case reports in Argus.
• Staff and train the functional area with necessary employees, consultants, and temporary workers.
• Oversee processes and workflows for safety data processing.
• Support Drug Safety Study Team Leads in reviewing protocols, case report forms, and participation in IND Annual Reports.
• Assist with metrics, budget forecasting, and headcount needs.
• Perform additional duties as required.

Supervisory Responsibilities:

• Directly supervise employees.
• Indirectly supervise through subordinate supervisors or a dotted line structure.

Education/Experience:

• BS/BA in a related field with 13+ years of experience, or
• MS/MA with 11+ years of experience, or
• PhD with 8+ years of experience, or
• Equivalent education and experience.

Ideal Experience:

• Required: Drug Safety and Operations experience.
• Preferred: Experience with Argus safety database.

Knowledge/Skills:

• In-depth knowledge of biotech/pharmaceutical practices.
• Strong understanding of international regulations and guidelines for clinical trial and post-marketing safety.
• Excellent problem-solving, organizational, and planning skills.