The Executive Director of GPS (Global Patient Safety) Risk Management is a key senior leadership position responsible for drug safety risk management planning and will drive all aspects of planning, operations, and processes globally to ensure the successful delivery of risk management pharmacovigilance (PV) requirements of Regeneron’s worldwide portfolio.
This global role will represent and manage internal and external relationships related to risk management and will work cross-functionally, serving as a key planning lead, working in coordination with all areas of GPS, along with Regeneron stakeholders and pharmacovigilance (PV) vendors.
This function oversees the achievement of GPS’s Risk Management planning and will set strategic goals, effectiveness and track progress toward these goals. The role is accountable for all elements of planning, overseeing status reporting, managing risks and issues, collaborating with stakeholders, developing operational methodologies, and proactively communicating with stakeholders on the delivery of Risk Management in support of the portfolio.
In this role, a typical day might include:
- In this critical leadership role, you will be responsible for providing oversight for Risk Management planning and pivotal risk management implementation and operations activities globally across the entire product lifecycle for Regeneron medicines and compounds.
- Key responsibilities include executing against the Risk Management strategies (e.g., US REMS, EU risk minimization measures as determined by GPS stakeholders and provide planning in support of the global portfolio.
- Establish and maintain Risk Management planning and processes to ensure compliance with global regulations related to assessments working in close collaboration across GPS areas, Regeneron stakeholders and vendors.
- Responsible to ensure Risk Management robustness and provides tracking and key performance metrics for GPS.
- Ensure the risk assessment processes are continuously improved to reflect best practices, regulatory trends, and guidelines working across with GPS, and Regeneron stakeholders.
- Serve as the in-house Risk Management operations expert and provide subject matter expertise on the implementation and delivery of risk management programs globally as required.
This role might be for you if:
- 15+ years' experience in risk management operations, including risk management planning and leadership experience in the pharmaceutical industry required.
- 8+ years of leading a matrix role that encompasses working across all areas of an organization and people management experience.
- Preferred minimum of 5 years of international pharmaceutical activities
- Strong leadership capabilities and presence, influencing skills, interpersonal, verbal, and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously.
- Proven expertise leading large-scale, strategic initiatives related to drug development, risk management/pharmacovigilance (PV) operations and global regulatory requirements.
- Preferred advanced life sciences degree: MPH, PharmD is an advantage.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)