Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA). They are 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. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management.
In this role, a typical day might include:
This Senior Director position is directly responsible for all aspects of GPS activities for assigned compounds of Ophthalmology 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 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 of General Medicines (GM)
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 ICSRs, 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 might be for you if have:
Strong knowledge of Ophthalmology
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.
Familiarity with development of therapies in Ophthalmology therapy area
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.
To be considered for this opportunity, you must have the following:
Board Certified MD/PhD with clinical experience in Ophthalmology or Hematology
5+ years of total relevant experience in PV and/or relevant medical field with a MD degree
10+ years of total relevant experience in PV 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)
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.