Senior Director, Global Patient Safety - Rare Disease

Regeneron Pharmaceuticals, Inc.; Cambridge (MA); Híbrido; USD 242.000 - 403.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Senior Director to join the Global Patient Safety team. You will lead GPS strategy for assigned compounds, shape safety profiles, and ensure safety surveillance across development stages, with significant cross-functional collaboration.

The role requires senior leadership, expertise in PSURs/DSURs, and the ability to influence in a matrixed environment. Travel up to 25% and on-site work four days a week in multiple locations.

Qualificações

• Total PV experience of 5+ years in PV or related medical field.
• 15+ years total relevant PV/medical field experience or equivalent in drug safety.
• Experience with PSURs/DSURs/(d) RMPS; or in clinical development with safety achievements.
• Experience in TA with advanced therapies such as gene therapy in pharmacovigilance.

Responsabilidades

• Lead safety strategy for assigned compounds and ensure cross-functional GPS support.
• Represent GPS on cross-functional teams (RSOC, IDMC, SPT) and SMT chairmanship.
• Mentor safety scientists and drive continuous improvement within GPS and TA.
• Ensure regulatory communications and safety documentation are accurate and timely.

Conhecimentos

PV experience

Leadership

Cross-functional collaboration

Regulatory knowledge

Safety strategy

Formação

PharmD / PhD / MD

Ferramentas

GPS safety database

Descrição da vaga

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.

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 IC's, 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.

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) $242,000.00 - $403,300.00