Executive Director, Global Patient Safety Sciences - Rare Disease

The Executive Director, Global Patient Safety Sciences, Rare Disease is the first point of contact for all Rare Disease strategy-related responsibilities across clinical, and post-marketed drugs in the portfolio. As the product subject matter expert (SME) and Therapeutic Area Head (TAH) for the Rare Disease portfolio, this role defines the product safety strategy, establishes the medical safety opinion, and provides the safety scientific POV across both GPS and non-GPS interactions.

In addition, the position acts as a trusted advisor to senior management regarding safety strategies/processes while developing organizational objectives and, importantly, understanding the impact of decisions across functional areas. The ED Global Patient Safety Sciences Rare Disease is responsible for the development of their team, which is comprised of GPS Leads.

They will serve as a member of the GPS Leadership Team (GPS LT).

• Contribute senior-level safety expertise to clinical projects across assigned therapeutic area

• Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds and serves as point of escalation for ICSR causality assessments

• Provide oversight for safety signal evaluations & deliver clinical interpretation of emerging safety issues

• Review benefit-risk assessments (e.g., HHAs) written by Safety Sciences Delivery and recommendations for the product safety profile as appropriate for the stage of the asset lifecycle for safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs)

• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI

• Influence cross-functional leaders to align priorities and drive enterprise results

• Approve and provide medical oversight for Risk Management Plans (RMPs)

• Approve responses to medical & clinical health authority queries as needed

• Oversee cross-functional Safety Monitoring Team (SMT) activities

• Represent GPS at cross-functional governance meetings including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with other parties external to Regeneron (e.g., collaborators)

• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines

• Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

• Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty preferred; MBA is an advantage

• 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required

• 6+ years of leading a team and people management experience, added benefit if in a matrixed environment

• Preferred 1-3 years of international pharmaceutical activities

• Proven track record in developing a deep understanding of the products’ safety profile, supported by in-depth product knowledge to inform safety assessments, risk evaluations, and decision-making

• Experience with oversight of strategy within a global patient safety organization

• Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.

In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together.

For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.