Reporting to the Head of Global Patient Safety(GPS), the GPS Therapeutic Area (TA) Head provides Pharmacovigilance (PV) and RM expertise, leadership, and mentorship to team members and direct management of relevant GPS personnel. This role is the single voice of GPS to the corporation for the assigned product portfolio and is accountable for all drug safety deliverables (medical & scientific drug safety and PV operational) that support products.
As Global Patient Safety Therapeutic Area Head, a typical day might include:
•Ensuring all drug safety deliverables (including ICSRs, aggregate reports, RSI, NDA/BLA safety-related submission documentation, risk management plans, REMS) required to satisfy regulatory obligations and support business clinical development strategies globally meet standards of quality and timeliness.
•Serving as primary point of contact for business lines outside the department for all PV-related activities for the TA, and in times of absence or unavailability assigns a deputy TA Lead.
•Responsible for oversight, planning and management of TA operational and safety science activities and performance.
•Providing direction and strategy on process improvements, individual and team interactions and overall TA efficiency.
This role might be for you if:
•You have excellent communication and leadership skills.
•You have an outstanding ability and skills to lead through ambiguity and work effectively with senior management and cross functional partners.
•You are very comfortable working within a highly matrixed environment and influencing across functional areas outside of direct line management.
To be considered for this position you must have an advanced degree, M.D. Degree preferred. Board Certification or equivalent in relevant clinical specialty a plus but not required. An MBA is a plus but not required. Fifteen plus years total experience in PV and/or relevant medical field or equivalent, including a preferred minimum five years of international pharmaceutical activities (such as Research & Development, Medical affairs). Hands on experience in oncology safety including leading NDA/BLA/MAA submission activities. Oncology or infectious disease clinical experience a plus. At least eight years of people management experience. Experience with the methodologies and tools used in a modern PV department (including case processing, safety databases, analytics, signal detection and management, and risk management).
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.