Executive Director, Global Patient Safety Sciences Delivery

BioSpace; Kuah; On-site; MYR 813,000 - 1,359,000; Full time

Job summary

Regeneron is seeking an Executive Director to join the Patient Safety team in Dublin. This role leads Safety Sciences operations, drives standardization across TAs, and oversees risk-related activities and governance processes.

You will manage a high-performing team and partner cross-functionally with Clinical, Regulatory, and Biostats leaders. Ideal candidates have extensive PV leadership experience, a strong track record in safety operations, and the ability to shape strategy and training

Qualifications

• Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty, MBA is an advantage.
• 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required
• 6+ years of leading a team and people management experience
• Preferred experience with oversight of operations within a global patient safety organization
• Strong attention to detail and ability to optimize Safety operations processes and ensure high-quality, compliant execution across activities
• Strong leadership, interpersonal, verbal and written communication skills and workload planning abilities

Responsibilities

• Define strategy to standardize and ensure consistent execution across products and TAs.
• Oversee training programs including standardized curricula, proficiency matrix, and knowledge repository.
• Enable GCC to operate more efficiently and scale with business demands.
• Develop innovative approaches that integrate new technologies, including AI.
• Ensure compliance and quality management of Safety Sciences Operations activities with SOPs and monitoring tools.
• Coordinate signal detection and management across TAs, SMT, SSP and SER.
• Support high-quality, timely benefit-risk assessments for periodic safety reports (DSURs/PSURs) and contribute to safety documents.
• Set and oversee a framework for aggregate safety data analysis.

Skills

Leadership

People management

Communication

Cross-functional collaboration

Attention to detail

Education

MD/DO/PhD/PharmD

Board Certification

MBA (advantage)

Job description

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team. The Executive Director, Global Patient Safety Sciences Delivery serves as the key point of contact for all Safety Sciences operations and risk-related responsibilities across all Therapeutic Areas (TAs). This role is responsible for driving consistency across the portfolio for standard activities performed by the Safety Scientists (e.g., data transformation, safety surveillance, SMT preparation, early draft of aggregate reports, signal evaluations, label enhancement justifications). This role is also responsible for the processes and written procedures that underpin the safety governance, and other fundamental processes within Safety Sciences. This role requires the ability to work cross-functionally, partnering with the Safety Sciences TAHs and other leaders. They will serve as a member of the GPS Leadership Team (GPS LT). The Executive Director, Global Patient Safety Sciences Delivery is also responsible for the development and management of their team. 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: Dublin, Ireland
• Travel: As needed

Discover Your Role

• Define the strategy to ensure standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs through development of common practices, processes, templates
• Oversee relevant training programs for GPS Safety Sciences, including a standardized training curriculum, proficiency matrix, and knowledge management repository
• Enable the Global Capability Center (GCC) to operate more efficiency and scale with the demands of the business
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI

Operational Delivery Oversight

• Ensure compliance and quality management of Safety Sciences Operations activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools
• Oversee all aspects of signal detection coordination and signal management process across all TAs, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER)
• Coordinate and support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required
• Set and oversee the framework for aggregate safety data analysis to ensure effective coordination and delivery

Cross-Functional Partnership

• Serve as strategic point of contact to enable SS operational delivery in partnership with TAHs and GPS Leads
• Partner with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management)

Talent Development & Organizational Leadership

• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
• Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

This Role Requires

• Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty, MBA is an advantage.
• 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required
• 6+ years of leading a team and people management experience
• Preferred experience with oversight of operations within a global patient safety organization
• Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities
• Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

172,500.00 - 288,300.00