Sr. Director Global Patient Safety - Hematology
- Regeneron Pharmaceuticals, Inc.
- Basking Ridge, New Jersey
- Start date
- Mar 23, 2023
- Administration, Clinical, Manufacturing & Production
- Required Education
- Position Type
- Full time
- Pharm Country, Best Places to Work
Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head for Hematology, the Senior Director, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the Hematology (including Hematologic Oncology) 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, as well as the delegate and back-up for the TAH within Hematology and the GPS Leadership Team. The GPS Lead owns the safety strategy and ensures the efficient 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 the following:
·Being 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.)
·Leading the 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 and back-up as needed for GPS Therapeutic Area Head, Hematology
·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 encouraging cross functional relationships and mentoring junior safety scientists
This role might be for you if:
·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 proven experience in Hematology including Hematologic Oncology.
·Familiarity with development of therapies, including oncology therapies.
·Comfortable and effective in serving as delegate and back-up to the Therapeutic Area Head.
·A proven track record to lead and develop a diverse team of Safety Professionals in a constructive, goal-oriented environment.
·An ability to work across organizational levels, optimally 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.
·MD, PhD, and/ or PharmDDoes 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.
Salary Range (annually)$203,600.00 - $339,300.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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