Senior Director Global Patient Safety

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director to join our Global Patient Safety team, supporting our assigned compounds in a hybrid setting. In this role, you will lead safety strategy while collaborating with cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Lead assigned-compound safety activities: surveillance, signal management, lifecycle-appropriate safety communication, benefit-risk assessment and regulatory responses.
• Oversee Development Safety Update Reports, Periodic Safety Update Reports, development Risk Management Plans and Risk Management Plans.
• Review Investigator Brochures, protocols and clinical study reports.
• Chair the Safety Management/Monitoring Team as the first safety contact, coordinating internal support and representing Global Patient Safety cross-functionally.
• Represent safety on the Strategic Program Team, Regeneron's Safety Oversight Committee, Independent Data Monitoring Committees and partner/contract research organisation teams.
• Deputise for the Therapeutic Area Head and develop non-compound safety strategies, including mechanism-of-action planning.
• Provide complex Individual Case Safety Report medical-review expertise and review other compound data sources.
• Develop standard operating procedures, working practices and guides through continuous improvement, cross-functional relationships and junior safety scientist mentoring.
• Influence collaboratively across internal and external matrix teams, including senior management.

Requirements

• Nursing, PharmD, PhD or MD degree.
• Five-plus years' relevant pharmacovigilance and/or medical experience with a listed degree.
• Ten-plus years' relevant pharmacovigilance/medical experience, or equivalent in lieu of PharmD/PhD/MD, including significant drug-safety reporting and risk-management experience.
• Alternatively, clinical-development experience with demonstrated safety achievements, such as integrated safety summary support or clinical study report content responsibility.
• Ability to influence colleagues across matrix teams, including senior management.
• Clinical and/or industry experience in the relevant therapeutic area is a plus.

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.

Pay

For jobs in Canada: this posting is for an existing position. Salary Range (annually) $242,000.00 - $403,300.00. 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.

Schedule

Multiple locations are being considered for this role (Hybrid). Regeneron believes they do their best work when together; 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.