Senior Director: Global Patient Safety Solutions Partner

BioSpace; New Jersey; On-site; USD 216,000 - 360,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Regeneron seeks a Senior Director, GPS Business Solution Lead to align GPS priorities with Digital & Technology, delivering on Argus, PIVIT, SRP and related safety platforms at scale.

You will partner with GPS leadership, IT, and Information Security to shape safety technology roadmaps, ensuring regulatory compliance and delivery excellence across platforms.

Qualifications

• Bachelor's degree in a related field; Masters preferred.
• 15+ years in enterprise Global Patient Safety or regulatory technology platforms.
• Experience leading a multi-disciplinary team of Directors and Managers with budget and vendor accountability.

Responsibilities

• Define GPS Platform Strategy & Ownership, aligning with GPS priorities and enterprise roadmap.
• Provide Delivery Oversight & Team Leadership across the safety platform portfolio; manage backlogs and releases.
• Ensure Data Governance & Regulatory Compliance for safety data and reporting.
• Foster Cross‑Functional & Vendor Partnerships to align roadmaps with enterprise standards.
• Engage Executives & Stakeholders with clear, strategic updates and governance discussions.

Skills

Budget & Vendor Management

Stakeholder Management

Team Leadership

Strategic Planning

Executive Communication

Regulatory IT Knowledge

Education

Bachelor's degree in Computer Science, Information Systems, Business Administration, or a related field

Masters degree preferred

Tools

Oracle Argus Safety

ICSR / Safety Platforms

Job description

The Senior Director, GPS Business Solution Lead will serve as the key interface between GPS business leadership and Digital & Technology, orchestrating D&T capabilities to deliver on Regeneron's Global Patient Safety (GPS) objectives and priorities across platforms, including Argus (safety), PIVIT, Signal Management, aRMM/ARMM, and SRP. This role owns the platform strategy and roadmap, prioritizing investment in partnership with the business, and will lead a team of Directors delivering delivery governance and regulatory‑compliant operations across the safety technology portfolio. The Business Solution Lead will partner closely with GPS business leadership, Enterprise IT, and Information Security to ensure safety systems support Regeneron's Global Patient Safety obligations and global regulatory commitments.

This role reports to the Executive Director, Global Development IT and will collaborate closely with GPS business leadership and Enterprise IT partners to shape the safety technology roadmap and ensure delivery excellence across the platform portfolio.

Where and When

This is an on‑site position 4 days/week, primarily based at our Sleepy Hollow, NY or Warren, NJ office. If eligible, we can offer relocation benefits; we cannot offer a fully remote option.

Key Responsibilities

• GPS Platform Strategy & Ownership Partner with senior GPS leadership, to align technology and capabilities to deliver on Global Patient Safety objectives and enterprise priorities. Own and prioritize, in partnership with the business, the multi‑year platform strategy and roadmap for Argus (safety), PIVIT, Signal Management, aRMM/ARMM, and SRP, translating Global Patient Safety and regulatory priorities into a funded, prioritized delivery plan. Own the organizational design of the GPS Business Solution function, including structure, role allocation, and resourcing across Directors and Managers assigned to the domain. Establish governance frameworks, standards, and validation practices for GPS platform delivery, ensuring consistency across teams and vendor engagements. Own budget, forecast, and vendor contract accountability for the GPS platform portfolio, including software licensing and services agreements.
• Delivery Oversight & Team Leadership Serve as the escalation and quality‑assurance point for planning, prioritization, and execution of safety platform initiatives led by direct reports. Oversee product backlog, incident management, and release governance across the GPS platform portfolio, ensuring consistent reporting of value delivered against plan. Coach and develop Directors and Managers, ensuring delivery commitments are met and domain capabilities continue to mature. Manage steering committee meetings, working groups, and issue/release management for upgrades to existing safety platforms.
• Data Governance & Regulatory Compliance Partner with GPS business leadership, Regulatory Affairs, and Quality organizations to ensure safety platforms meet GxP validation, data integrity, and audit‑readiness standards. Own data classification, access, and quality standards for safety‑related data, ensuring compliance with global safety reporting obligations (e.g., FDA, EMA). Maintain oversight of case processing, signal detection, and risk management workflows to ensure platforms support timely and accurate regulatory reporting.
• Cross‑Functional & Vendor Partnership Partner with Enterprise IT, Enterprise Architecture, and Information Security to align safety platform investments with enterprise standards and security requirements. Build and maintain relationships with key platform vendors to clarify demands, resolve conflicts, and align technology roadmaps to business needs. Represent GPS technology priorities in enterprise architecture and governance forums, ensuring alignment with enterprise‑wide standards.
• Executive & Stakeholder Engagement Serve as the primary point of contact for senior GPS and IT leadership on matters requiring negotiation of complex or ambiguous issues. Build relationships with key GPS business leaders to clarify demands, resolve conflicts, and align technology roadmaps with pharmacovigilance priorities. Monitor industry trends in drug safety technology and regulatory reporting, bringing forward innovative approaches to senior leadership. Prepare and deliver executive‑level materials on the health and roadmap of the GPS platform portfolio for governance forums and senior leadership.

Qualifications And Requirements

Education & Experience Bachelors degree in Computer Science, Information Systems, Business Administration, or a related field (Masters degree preferred).

15+ years of progressive industry/relevant professional experience, including significant experience managing enterprise‑scale Global Patient Safety, drug safety, or regulatory technology platforms.

Experience in the biotech, pharma, or life sciences industry strongly preferred.

Proven experience leading a multi‑disciplinary team of Directors and Managers, including budget and vendor contract accountability for a major function.

Technical Expertise

Deep expertise in patient safety and drug safety systems (e.g., Oracle Argus Safety, signal management, and risk management platforms).

Experience with global safety reporting standards and regulatory requirements (e.g., E2B, ICSR, FDA, EMA).

Strong knowledge of GxP validation practices and solution delivery life cycle management.

Experience managing technology capability identification, selection, and implementation across multiple simultaneous safety platform initiatives.

Skills & Competencies

Proven track record of budget and vendor management for a department or major function.

Strong stakeholder management and negotiation skills, with experience influencing senior management internally and externally.

Demonstrated ability to grow, motivate, and develop teams, coaching Directors and Managers through career milestones and progression.

Strategic mindset with the ability to define organizational structure and set long‑term goals and objectives for a major function.

Exceptional executive communication skills, with experience engaging senior/executive leadership on sensitive or ambiguous matters.

Certifications (Preferred)

PMP or equivalent project/program management certification.

ITIL or SAFe Agile certification.

Equal Opportunity

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.

Salary and Benefits

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.

Recruitment Process

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)

$216,100.00 - $360,200.00