Senior Director Global Patient Safety

BioSpace; Dublin (OH); Hybride; USD 144 000 - 240 000; Plein temps

Avantages offerts par ce poste

Annual bonuses or other incentiveplans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental,‑)

Résumé du poste

Regeneron is seeking a Senior Director to join the Global Patient Safety team, supporting assigned compounds in a hybrid setting. You will lead safety strategy while collaborating with cross-functional teams to advance life-changing medicines for patients worldwide.

You will chair safety meetings, oversee risk management plans, and influence senior management across internal and external partners. A senior pharmacovigilance background is required.

Qualifications

• Five or more years relevant pharmacovigilance and/or medical experience with a listed degree.
• Ten or more 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.

Responsabilités

• 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, Regenerons 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.
• You influence collaboratively across internal and external matrix teams, including senior management.

Connaissances

Pharmacovigilance

Medical experience

Influence across matrix teams

Clinical development

Therapeutic area knowledge

Formation

Nursing/PhD/MD degree

Description du poste

Build Our Future Together

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.

When & Where

Multiple locations are being considered for this role (Hybrid)

Discover Your Role

• 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, Regenerons 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.
• You influence collaboratively across internal and external matrix teams, including senior management.

This Role Requires

• 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.

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
• 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. If you have any questions, please speak with your recruiter.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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.

Salary Range (annually)

143,900.00 - 240,100.00