Job Summary 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. Location participate in clinical study team meetings for assigned compounds Participate in other risk management activities as appropriate for assigned compounds 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 Requirements Minimum a Master's, PhD, or PharmD (Terminal Degree preferred) Offers 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-marking environments Ability to work with a safety system database for purposes of medical case review and simple querie Able to be proactive and self-disciplined, able to meet deliverables, and effectively use your time and prioritize 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 EEO
Associate Director, Global Patient Safety - Ophthalmology employer: Regeneron UK Limited
Regeneron UK Limited is an exceptional employer, offering a dynamic and collaborative work culture in Uxbridge that fosters innovation and professional growth. With a strong emphasis on employee development, you will have the opportunity to lead impactful projects in Global Patient Safety while working alongside talented cross-functional teams. The company's commitment to science-driven excellence and patient safety makes it a rewarding place for those looking to make a meaningful difference in the field of rare diseases.
