Director, Global Patient Safety Sciences - General Medicine

BioSpace; Cambridge (MA); On-site; USD 205,000 - 342,000; Full time

Job summary

Regeneron is seeking a Director of Global Patient Safety to lead safety strategy for assigned assets and to serve as the GPS representative on cross-functional programs. This role requires influencing stakeholders in a matrix environment and coordination with external partners to drive pharmacovigilance across development and commercialization.

The position focuses on safety surveillance, signal management, regulatory communications, and the development of safety documents while mentoring a

Qualifications

• 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.

Responsibilities

• 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 ICRS, 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.

Skills

PV leadership

Cross-functional leadership

Regulatory knowledge

Safety strategy

Education

PharmD

PhD

MD

Job description

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 Regenerons 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

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 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 ICRS, 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

#MDJOBSPS #GDPSJobs

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.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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

If you have any questions, please speak with your recruiter.