Associate Director, Global Patient Safety - Ophthalmology

Regeneron Pharmaceuticals • Warren, MA

2d • Onsite

About The Position

Regeneron is seeking an Associate Director to join its Global Patient Safety team. This scientific role contributes to safety strategies for molecules in clinical development and post-marketing phases. The position involves aggregating, reviewing, and analyzing safety data to support appropriate safety interpretation and benefit-risk assessments. The work location is Tarrytown, NY; Warren, NJ; or Cambridge, MA, with four days per week on site. Travel of up to 25% may be required.

Requirements

• At least a Master's, PhD, or PharmD; a terminal degree is preferred.
• At least 10 years of relevant risk management experience in the pharmaceutical or biotechnology industry or at a health authority.
• Previous safety or relevant clinical experience in the pharmaceutical industry; typically, at least 8–10+ years of risk management or relevant clinical experience in the pharmaceutical or biotechnology industry or at a health authority.
• Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance in clinical trial and post-marketing environments.
• Ability to use a safety system database for medical case review and simple queries.
• Ability to work proactively and with self-discipline, meet deliverables, manage time effectively, and prioritize.
• Ability to communicate safety findings effectively, verbally and in writing.

Nice To Haves

• Clinical and/or industry experience in the therapeutic area of interest.

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plans.
• Evaluate identified signals and author safety evaluation reports.
• Manage preparation and review of safety documents, including DSURs, PSURs, RMPs, and responses 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 for assigned compounds, as appropriate.
• Represent Global Patient Safety on cross-functional teams, potentially including the Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and teams with external members.
• Provide medical review support for assigned compounds.
• Participate in process improvement initiatives, including development and maintenance of relevant SOPs, work instructions, and supporting documents.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability insurance, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Director