Regeneron

Pharma

Director,GlobalPatientSafetySciences

$205–342k Tarrytown, New York, United States; Warren, New Jersey, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Director, Global Patient Safety Sciences at Regeneron. Skills: Patient Safety, Drug development, Regulatory compliance. Lead safety strategy. Ensure optimal support from GPS”

What You'll Achieve.

Deliver safety strategy

Industry & Context.

Pharma
Problems you'll solve

Critical analysis

Eligibility Requirements

4 days per week on site

What They're Looking For.

Must Have

10+ years experience in PV, 5+ years experience in PV, PharmD / PhD / MD degree, Clinical experience in Oncology, Industry experience in Oncology

Nice to Have

Experience with PSURs/DSURs, Experience supporting CSR content

What You'll Do.

Ensure optimal support from GPS

Deliver safety strategy

Manage all aspects of Global Patient Safety

Support safety surveillance

Support signal management

Communicate safety profile

Support benefit risk assessment

Provide safety responses

Prepare safety documents

Review clinical documents

Lead Safety Monitoring Team activities

Represent Global Patient Safety

Identify safety strategies

Develop safety strategies

Plan Global Patient Safety activities

Provide medical review

Develop relevant SOPs

Maintain relevant SOPs

Participate in continuous improvement

Cultivate cross functional relationships

Mentor junior safety scientists

Provide critical analysis

Function as subject matter expert

Communicate safety viewpoints

Communicate safety findings

Recommend risk management

Recommend minimization activities

Utilize GPS safety database

Perform medical case review

Perform simple queries

How You'll Work.

Team & Collaboration

Cross functional teams; Senior management; Alliance partners; CROs

Communication Scope

Safety viewpoints; Safety findings

Process & Methodology

Program team

Full Job Description

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 or Warren, NJ * 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), Indepe

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