Director, Global Patient Safety Sciences - Oncology
Location: Tarrytown
Posted on: June 23, 2025
|
|
|
Job Description:
The Global Patient Safety (GPS) Lead role (Director of GPS)
serves as the first point of contact (POC) for all safety related
issues for the compound(s) [asset(s)] assigned within a given
therapeutic area (TA), and is the GPS representative on the cross
functional strategic program team (SPT) 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 strategy. This position requires the ability to work
with and influence colleagues in a matrix environment within and
external to GPS including senior management. The GPS Director joins
Regenerons industry leading scientific organization, and has a
direct impact on drug development, operations, and
commercialization in all relevant global territories. In this role,
a typical day might include: This Director position is directly
responsible for all aspects of Global Patient Safety 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.) Leads cross-functional Safety
Monitoring Team (SMT) activities Represent Global Patient Safety
for assigned compounds on cross-functional teams, including
Regenerons Safety Oversight Committee (RSOC), Independent Data
Monitoring Committees (IDMC), Strategic Program Team (SPT) and
other teams with members external to Regeneron (alliance partners,
CROs) Proactively identify and develop safety strategies and
planning for non-compound specific Global Patient Safety 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 This role might be for you
if can/have: 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. 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. To be considered for this opportunity, you must
have the following: Minimum 10 years of total relevant experience
in PV and/or relevant medical field or equivalent of 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). 5 years of total relevant experience in PV and/or
relevant medical field with PharmD / PhD / MD degree required.
Clinical experience and/or industry experience in Oncology is a
plus GDPSJobs Does this sound like you? Apply now to take your
first step towards living the Regeneron Way! We have an inclusive
and diverse culture that provides comprehensive benefits, which
often include (depending on location) health and wellness programs,
fitness centers, 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. 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. Salary Range (annually) $202,000.00
- $336,600.00
Keywords: , Elizabeth , Director, Global Patient Safety Sciences - Oncology, Science, Research & Development , Tarrytown, New Jersey
