Director of Clinical Drug Safety & Physician

Shape the future of drug safety with expert leadership across global development and post-market phases.

R&D Partners is seeking a Director of Clinical Drug Safety & Physician to provide strategic safety leadership across multiple programs or therapeutic areas. This role is pivotal in ensuring the safety profile of assigned products throughout their lifecycle, from pre- to post-marketing surveillance, in compliance with global health authority regulations.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead global safety strategy for program teams, ensuring data-driven review and assessment.
• Oversee safety signal detection and benefit-risk assessments for assigned products.
• Represent global safety at cross-functional meetings on development projects and studies.
• Collaborate with cross-functional teams (e.g., Biostatistics, Clinical, Regulatory Affairs) to develop risk management strategies for safety signals.
• Provide senior medical safety leadership in governance forums, including Safety Review Committees and Data Monitoring Committees.
• Author and update aggregate safety reports, regulatory safety submissions, and safety sections of filings.
• Participate in the development of safety-related data collection standards for clinical studies.
• Confirm regulatory submission assessments and approve SUSARs before submission.
• Provide medical review of Serious Adverse Event reports to ensure timely regulatory submissions.
• Ensure compliance with global pharmacovigilance regulations (e.g., CIOMS, EMA, FDA, ICH).
• Contribute to safety process improvements and best practices across the organization.
• Participate in regulatory inspections and internal audits.

Key Skills and Requirements:

• Medical Degree (MD or MD-PhD) required.
• Minimum **10 years of industry experience** in clinical safety with leadership responsibilities.
• Strong understanding of global pharmacovigilance principles, regulatory requirements, and MedDRA coding.
• Expertise in signal detection, evaluation, and aggregate data analysis in clinical trials.
• Excellent analytical and critical thinking skills for evaluating complex medical data.
• Strong communication and collaboration skills to interact effectively with cross-functional teams.
• Proven ability to prioritize and deliver results within aggressive timelines.
• Experience authoring safety-related documents, including protocols, IBs, ICFs, and RMPs.

For more information, please contact William Tyler.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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