Exec Dir Global Patient Safety - Ophthalmology
Reporting to the Head of Global Patient Safety (GPS), the Global Patient Safety Therapeutic Area (TA) Head provides PV and RM expertise, leadership, and mentorship of team members within the TA matrix and direct management of relevant GPS personnel within the TA. The TA Head is accountable for all drug safety deliverables (medical & scientific drug safety and PV operational) that support products within the assigned portfolio. The TA Head is the single voice of GPS to the corporation for the assigned product portfolio. This position requires ability to work with and influence colleagues in a matrix environment and with senior management and is a key member of the Patient Safety Leadership Team. The TA Head has a major impact on drug development and commercialization decisions, strategies and operations, in all relevant territories globally.
In this role, a typical day might include the following:
- Independently ensures 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
- Primary point of contact for business lines outside the GPS department for all PV-related activities for the TA, and in times of absence or unavailability assigns a deputy TA Lead
- Provide Matrix Leadership for all GPS Department individuals who support the TA, mentoring and developing competencies for TA members and other GPS staff involved with the TA
- Directly manages individuals within the TA in accordance with corporate personnel management policy and contributes feedback on matrix members of the TA teams to their direct managers
- Maintains Therapeutic Area expertise, product portfolio-specific expertise and ongoing assessment of therapeutic areas, competitive drugs and therapies and applicable regulations
- Identifies potential operational issues impacting the execution of strategic development plans for the GPS department and advises on appropriate mitigation plans, leading the implementation of these if required.
- Provides consultative and administrative leadership to Head of the Department (GPS)
- Works collaboratively, and through effective communication, to progress selected Department (GPS) projects toward successful completion
- Interacts with other business leaders and external authorities/entities to gain alignment and commitment, applies understanding and knowledge outside area of expertise
- Responsible for oversight, strategic planning and management of TA operational and safety science activities and performance.
- Provides direction and strategy on process improvements, individual and team interactions and overall TA effectiveness.
- Plays a key strategic role in orchestrating the management of safety information across the Regeneron development and commercial portfolio for the TA
- Consistently works with situations that have company-wide reach, or significant impact on business results
- Decisions will result in the short-term success of the function, and will influence the long-term success of the business overall
- Works with numerous other functions at Regeneron on cross-functional issues that includes issues beyond Global Patient Safety
- Can provide long-term strategic direction and business solutions for GPS functional areas, helping to establish priorities and identify accountabilities for overall results
- Oversees the management of ICSRs and aggregate data analysis and presentation for the TA
- Leads signal detection and management activities for the TA
- Plans and proposes appropriate risk mitigation for identified safety hazards
- Drives alignment of stakeholder thinking on benefit/risk and to address related uncertainties relating to the assigned product portfolio
- Ensures drug safety decisions are made, recorded and actioned according to regulatory and company standards
- Refers important drug safety topics for risk/management decision to the appropriate company governance committee, and prepares for advisory committees / oral explanations / major regulatory meetings
- Foster communication and collaboration with other TA heads, through participation on the GPS Department Leadership team.
- to standardize best practices
- on handling challenges with regard to daily activities
- Contributes to the design, and supports implementation, of state-of-the-art PV systems and processes across the Global Patient Safety Department
Performance of the TA
- Reviews and responds to measures of performance (including metrics, KPI, feedback from stakeholders) and drives process enhancements
- Collaborates with the GPS Department Quality and Compliance group, and with Regulatory QA, to ensure that deviations are investigated through root cause analysis and remedial action is taken to address deficiencies
- Ensures direct reports complete assigned training in accordance with corporate policy and works with the GPS Department Quality and Compliance group to ensure that the TA is inspection-ready at all times
- Completes all assigned training in accordance with the requirements of the job
- Maintains current knowledge of US and international pharmacovigilance requirements relating to signal management, risk/benefit assessment and risk management
- Actively participates in continuous improvement activities within both the TA and the GPS organization
This role might be for you if:
- Preferred M.D. Degree. Board Certification or equivalent in relevant clinical specialty, or MBA, is an advantage.
- More than 10 years total experience in PV and/or relevant medical field or equivalent, including a preferred minimum 5 years of international pharmaceutical activities (such as Research & Development, Medical affairs)
- Hands on experience in Ophthalmology safety including leading NDA/BLA/MAA submission activities
- Ophthalmology clinical experience a plus
- At least 8 years supervisory experience managing direct reports or in a matrix organization with proven proficiency in organizational and planning capabilities
- 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)
- Ability to lead safety assessment and risk management strategies and influence corporate thinking
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.