Director, Clinical Safety

This position is posted by Jobgether on behalf of MCRA. We are currently looking for a Director, Clinical Safety in District of Columbia (USA).

As a Director of Clinical Safety, you will play a critical leadership role in overseeing safety-related operations across multiple clinical trials. This position requires in-depth collaboration with cross-functional teams to ensure high-quality execution of safety reviews, CEC and DSMB processes, and medical monitoring. The role combines scientific insight, regulatory expertise, and strategic oversight to help deliver compliant, patient-centric clinical solutions. Ideal candidates thrive in fast-paced, evolving environments, and bring both strong communication skills and a deep understanding of safety governance in clinical research.

Accountabilities:

• Lead and manage the Safety team, serving as the primary point of escalation for all safety-related issues across clinical trials.
• Oversee execution of Clinical Event Committees (CEC), Data Safety Monitoring Boards (DSMB), and Medical Monitor reviews, ensuring consistency and regulatory compliance.
• Develop and review charters, safety narratives, and supporting documentation aligned with Good Clinical Practice (GCP), ICH, and protocol-specific procedures.
• Coordinate closely with internal stakeholders — project management, regulatory, biostatistics, and data management teams — to ensure timely preparation of meeting materials.
• Recruit and manage independent medical experts to serve on safety oversight committees.
• Provide clinical and operational support to the business development team during client engagements and proposals.
• Monitor project timelines and reporting metrics related to safety activities.
• Deliver process training to internal staff and contribute to continuous improvement initiatives.

• Bachelor's degree in a health sciences discipline.
• Minimum 5 years of experience in clinical trial management, with at least 3 years focused on safety meetings and oversight.
• Strong knowledge of GCP, FDA regulations, and clinical project management best practices.
• Experience using Electronic Data Capture (EDC) systems and clinical trial management platforms.
• Proficient in MS Office applications; excellent communication and documentation skills.
• Ability to manage multiple projects, teams, and stakeholders effectively.
• Availability for 1–3 evening meetings per week depending on client scheduling.
• Proven ability to collaborate cross-functionally and maintain professional relationships with clients and committee members.

• Competitive salary package aligned with experience and responsibilities.
• Flexible work arrangements, including remote-friendly structure.
• Health, dental, and vision insurance coverage.
• Opportunity to work at the forefront of medical device and life sciences innovation.
• Global exposure with diverse client projects across therapeutic areas.
• Ongoing learning and development in regulatory and clinical operations.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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