Associate Director, Global Patient Safety - Ophthalmology

Regeneron UK Limited; Uxbridge; Hybrid; GBP 120,000 - 170,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron is seeking an Associate Director for Global Patient Safety in the Uxbridge area. The role focuses on safety data aggregation, review, and interpretation to support benefit-risk assessments across clinical development and post-marketing phases.

Ideal candidates have extensive pharmacovigilance experience, strong leadership skills, and the ability to guide cross-functional teams in safety evaluations and regulatory submissions. The position is based on-site in the UK, with some travel.

Qualifications

• Master's, PhD, or PharmD required or preferred for leadership in pharmacovigilance.
• Strong background in risk management and safety signal handling.
• Experience applying FDA/EU/ICH pharmacovigilance guidelines.

Responsibilities

• Lead signal detection and evaluation in line with safety surveillance plans.
• Prepare safety documents (DSUR, PSUR, and RMP) and respond to health authorities.
• Present at SMT meetings and collaborate with cross-functional teams.
• Mentor and advise on pharmacovigilance activities for assigned compounds.
• Contribute to SOP and process improvement initiatives.

Skills

Risk management

Pharmacovigilance

Safety assessments

Communication skills

Project management

Regulatory knowledge

Education

Master's degree

PhD

PharmD

Tools

Safety database

Job description

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 & Working Hours

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

Responsibilities

• 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
• 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 & Inclusive Culture Statement

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.

Salary and Compensation

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 bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

Additional Benefit Information

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Recruitment Process & Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position.

About Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

On-site Expectations

For that reason, many roles are required to be performed on-site.

Regeneron Philosophy

Please be advised that at Regeneron, we believe we do our best work when we are together.

Does this sound like you?

Does this sound like you?