Associate Director, Clinical Trial Patient Safety

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Assist the Clinical Trial Patient Safety organization in assessing and ensuring the quality of clinical trial patient safety data.

• Spearhead global surveillance of clinical trial patient safety data, which includes organization, resource allocation, and ongoing enhancements.

• Oversee designated operational areas, compound-related clinical studies, and associated systems to guarantee compliant and timely monitoring of adverse events.

• Establish, track, assess, and convey workload forecasts and operational metrics.

• Facilitate training initiatives, knowledge acquisition, and professional development of staff.

• Foster and maintain an environment that attracts, cultivates, and retains scientific talent.

• Plan and execute talent management strategies.

• Support strategic planning and the development of the department.

• Develop and engage in special projects and initiatives related to CTPS.

• Implement ICH, FDA, and EMA regulations and guidelines pertaining to drug safety responsibilities and global reporting standards.

• Collaborate with therapeutic-area physicians and medical monitors to oversee safety reviews at the compound-study level.

• Supervise safety reports, IRB/IEC safety concerns, narratives, issue management, document management systems, and centralized data assessments.

• Relay and escalate pertinent study and team information to clinical team members and management.

• Comprehend, execute, and enhance department SOPs and new regulatory requirements.

• Maintain communication with clinical, medical, regulatory, compliance, and pharmacovigilance counterparts.

• Manage a team of 5 to 10 individuals.

⛳️ Requirements

• A Bachelor’s degree in a healthcare-related field, such as Life Science, Pharmacy, Nursing, healthcare profession, or biomedical disciplines.

• A graduate degree is preferred.

• A minimum of 10 years of experience in clinical research within the pharmaceutical sector.

• Experience in project management involving cross-functional projects.

• Comprehensive understanding of the drug development process, which includes clinical trial execution, scientific strategy, operations management, regulatory submission requirements, product launch, and post-marketing support.

• Proven experience in clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations.

• Familiarity with tools, standards, and methodologies for effectively evaluating drug safety.

• Experience in a multidisciplinary, matrix team environment and adeptness in managing change.

• Strong leadership and communication skills, including the ability to convey project goals, issues, risks, and other project-related information.

• Excellent judgment in resolving conflicts and negotiations constructively while fostering effective working relationships.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.