Senior Manager, Global Patient Safety Sciences - Oncology

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); Presencial; USD 151.000 - 246.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager for Global Patient Safety to drive safety strategies for clinical and post‑marketing programs. You will lead signal detection, evaluation and the preparation of DSUR/PSUR/RMP documents while coordinating with RSOC and IDMC teams.

The role emphasizes data aggregation, safety interpretation, benefit‑risk assessment and proactive process improvements in a fast‑growing, science‑driven environment.

Formación

• Minimum a Master's, PhD, or PharmD.
• 7+ years of relevant risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH guidelines for pharmacovigilance in trials and post‑marketing.
• Ability to work with a safety system database for medical case review and queries.
• Proactive, self‑disciplined with ability to meet deliverables and prioritize.
• Effective verbal and written safety communication.

Responsabilidades

• Complete signal detection activities per the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and responses.
• Prepare and deliver SMT presentations; join study teams for compounds.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross‑functional teams (RSOC, IDMC, etc.).
• Contribute to SOPs, WIs and related process improvements.

Conocimientos

Signal detection

Safety signal evaluation

Safety documentation

Presentation skills

Cross-functional collaboration

Process improvement

Educación

Master's/PhD/PharmD

Descripción del empleo

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 Manager to join our Patient Safety team. The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post‑marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit‑risk assessment. 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 or Warren, NJ 4 days per week on site

Discover your role

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• Represent GPS on cross‑functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

This role requires

• Minimum a Master's, PhD, or PharmD
• Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post‑marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple queries
• Able to be proactive and self‑disciplined, you can meet deliverables, and effectively use your time and prioritize
• Ability to effectively communicate (verbal and written) safety findings

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.

Salary Range (annually) $150,500.00 - $245,500.00

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.

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace 2020, Forbes JUST companies in 2020, among others.