Associate Director, Global Patient Safety - Ophthalmology in Uxbridge

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety team. The Associate Director of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessments. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Uxbridge, UK
• 3 days per week on site
• 25% Travel may be required

Discover your role:

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Resource for medical review of assigned compounds
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

This role requires:

• Minimum a Master's, PhD, or PharmD (Terminal Degree preferred)
• 10+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple queries
• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritise
• Ability to effectively communicate (verbal and written) safety findings
• Provide a background that includes: Master's, PhD, or PharmD
• Clinical experience and/or industry experience in the TA of interest is a plus

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture.