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)
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-marketing 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, you can 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
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. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective…