Associate Director, Global Patient Safety - Ophthalmology

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Paid time off

Global wellness programs

401(k) company match

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director in Global Patient Safety (GPS) to lead safety strategies for molecules in development and post‑marketing. The role involves safety data aggregation, risk assessment, and preparation of safety reports while collaborating with cross‑functional teams across regions.

The candidate should have 10+ years in risk management within pharma/biotech, with deep experience in regulatory guidelines and safety systems. On‑site work at multiple U.S.

Qualifications

• Minimum a Master’s, PhD, or PharmD (terminal degree preferred).
• 10+ years of risk management experience in pharma/biotech or health authority.
• 8–10+ years of risk management or relevant clinical experience in pharma/biotech/health authority.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance in clinical trial and post‑marketing settings.
• Ability to work with a safety system database for medical case review and basic queries.

Responsibilities

• Perform signal detection activities in line with the safety surveillance plan.
• Evaluate signals and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and respond to inquiries.
• Deliver presentations at SMT meetings and participate in study team meetings.
• Engage in risk management activities and contribute to SOPs and supporting documents.

Skills

Safety risk management

Signal detection

FDA/EU/ICH guidelines

Clinical safety experience

Communication (written)

Education

Master's degree / PhD / PharmD

Tools

Safety database

Job description

Associate Director, Global Patient Safety - Ophthalmology

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

• Location: Tarrytown, United States of America, Basking Ridge, United States of America and 5 other locations
• Location: Warren, United States of America, Tarrytown, United States of America and 1 other locations

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Showing slide 1 of 4 (group 1 of 2)

Stay connected