Associate Director, Global Patient Safety - Ophthalmology

Regeneron; Kentucky; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety (GPS) to play a key scientific role in safety strategies for molecules in clinical development and post-marketing stages.

You will aggregate, review, and analyze safety data to support interpretation and benefit-risk assessments, contributing to a fast-growing, science-driven organization that helps patients worldwide.

Qualifications

• Master's, PhD, or PharmD (terminal degree) required.
• 10+ years of relevant risk management experience in pharma/biotech.
• 8–10+ years of risk management or clinical experience in pharma/biotech.
• Knowledge of FDA/EU/ICH pharmacovigilance guidelines.
• Experience with safety systems databases for medical review and queries.
• Strong communication of safety findings (verbal and written).

Responsibilities

• Conduct signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare/review DSUR, PSUR, and risk management plans; respond to authorities.
• Present at SMT meetings and participate in clinical study team meetings.
• Engage in cross-functional teams (RSOC, IDMC) as needed.
• Provide medical review for assigned compounds and contribute to SOPs and supporting docs.

Skills

Risk management

Safety evaluation

Communication skills

Clinical/pharma experience

Education

Master's degree

PhD

PharmD

Tools

Safety database systems

Job description

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: Tarrytown, NY, Warren, NJ or Cambridge, MA

4 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? 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 bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.