Director, Global Patient Safety Sciences - Oncology

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Híbrido; USD 205.000 - 342.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Director of Global Patient Safety to lead safety strategy for assigned compounds and act as GPS representative on strategic teams. The role requires extensive PV experience and collaboration across internal and external partners.

You will guide safety surveillance, signal management, and regulatory communications (DSURs/PSURs), mentor engineers, and contribute to SOPs. Hybrid work with on-site requirements is expected in multiple locations.

Formación

• Minimum 10+ years total experience in PV or related medical field.
• 5+ years PV experience with PharmD/PhD/MD.
• Oncology experience is a plus.

Responsabilidades

• Lead safety strategy for Global Patient Safety (GPS) for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC, SPT) and collaborate with external partners.
• Develop and maintain safety documents (DSURs, PSURs, development RMPs).
• Mentor junior safety scientists and contribute to SOPs and best practices.

Conocimientos

Pharmacovigilance

Safety strategy

Regulatory compliance

Educación

PharmD / PhD / MD

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 Director to join our Patient Safety team. 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 Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories. 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 Hybrid; 4 days per week on site

Discover your role:

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 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). 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 ICsRSs, 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. 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.

This role requires:

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.

Does this sound like you?

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.

Salary Range (annually) $205,000.00 - $341,600.00

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 for Innovators in 2020, and Forbes JUST companies in 2020, among others.