Senior Director, Global Patient Safety - Rare Disease

Regeneron; New Jersey; On-site; USD 210,000 - 260,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Senior Director in Global Patient Safety (Rare Disease) to lead safety strategy across assigned compounds, including DSURs/PSURs and regulatory interactions.

You will chair SMTs, collaborate with RSOC/IDMC/SPT, and mentor a diverse team of safety professionals. The role requires deep pharmacovigilance expertise, strategic thinking, and the ability to influence across matrixed teams.

Qualifications

• 5+ years total relevant experience in PV/medical field with PharmD/PhD/MD.
• 15+ years total relevant experience in PV/medical field or equivalent in lieu industry experience in drug safety including DSURs/PSURs/RMPs.
• Experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices.
• Ability to apply and provide critical analysis of FDA, EU and ICH guidelines governing pharmacovigilance activities.
• Function as a subject matter expert internal and external to GPS for assigned compounds.
• Thorough understanding of drug development and safety surveillance.
• Proven ability to lead and develop a diverse team of safety professionals.
• Ability to communicate safety viewpoints across organizational levels and recommend risk minimization.

Responsibilities

• Lead GPS safety strategy for assigned compounds and ensure optimal support within GPS.
• Oversee safety surveillance, signal management, and regulatory responses for safety profiles.
• Chair the Safety Management Team and represent GPS on cross-functional teams (RSOC, IDMC, SPT).
• Mentor junior safety scientists and contribute to SOPs and guides.
• Collaborate with stakeholders to deliver robust safety profiles and risk management.

Skills

PV leadership

Safety surveillance

DSUR/PSUR

Cross-functional leadership

FDA/EU/ICH guidelines

Education

PharmD/PhD/MD

Tools

GPS safety database

Job description

Senior Director, Global Patient Safety - Rare Disease

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
• 4 days per week on site
• 25% Travel may be required

Discover your role:

• Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA).
• This position is directly responsible for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.)
• The GPS Lead is the GPS representative on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound.
• The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety profile and the safety strategy.
• Assigned compounds will include a variety obesity/metabolism products in various stages of development.
• This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management.
• Leads cross-functional Safety Monitoring Team (SMT) activities Represent GPS for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs)
• Serves as delegate as needed for GPS Therapeutic Area Head, General Medicine
• Proactively identify and develop safety strategies and planning for non-compound specific GPS activities (mechanism of action etc.)
• Act as a resource for medical review for complex ICARS, and other data sources of assigned compounds
• Actively participate in the development and maintenance of relevant SOPs, working practices and guides
• Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists

This role requires:

• 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree
• 15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content)
• Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices
• Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest.
• Thorough understanding of drug development and context as applicable to safety surveillance activities
• A proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment.
• An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities.
• Ability to utilize GPS safety database for purposes of medical case review and simple queries.

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, 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. 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.

• Location: Warren, United States of America, Tarrytown, United States of America and 1 other locations
• Location: Tarrytown, United States of America, Basking Ridge, United States of America and 5 other locations
• Location: Cambridge, United States of America, Tarrytown, United States of America and 1 other locations

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one‑way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

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