Hybrid Senior Director, Global Patient Safety Strategy

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

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.