New · posted Nov 1
Regeneron · Biotechnology
Senior Director, Global Patient Safety - Rare Disease
- Tarrytown, NY +2 more
- Hybrid
- Full-time
- Director
The role
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.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
What you need
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.
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.
What you'll do
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 ICSRs, 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
Pay and benefits
$242,000 – $403,300 a year
Employer provided$242,000.00 - $403,300.00
Annual bonuses and incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Tarrytown, NY +2 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Warren, NJ · Cambridge, MA
More jobs in Tarrytown, NY +2 moreWorking conditions
When & where
- Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
- 4 days per week on site
- 25% Travel may be required
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% above the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in New York9 roles publishing pay
Director roles in the US90 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $242,000 | — | $403,300 |
| New York (middle half) | $273,500 | $273,500 | $273,500 |
| All US (middle half) | $218,875 | $264,000 | $281,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 162 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Clinical trial conduct5
- Quality systems and risk3
- Documentation and SOPs2
- GMP and compliance1
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Regeneron on Regulatory Jobs
- 163
- Open roles
- 140
- Distinct roles
- 11
- Locations
By discipline
- Clinical69 42%
- Quality67 41%
- Regulatory27 17%
By level
- Associate & Specialist53 33%
- Director49 30%
- Manager46 28%
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Senior Director, Global Patient Safety - Rare Disease at Regeneron
Open until filled. $242K–$403K a year, employer provided.