Senior Director, US Risk Management & Product Safety (REMS)

Band

Level 6

Job Description Summary

Location: East Hanover NJ

#LI-Hybrid

Relocation Support: Novartis is unable to offer relocation support - please only apply if this location is accessible to you

Join Novartis in a pivotal leadership role where patient safety and innovation intersect. As Senior Director US Risk Management & Product Safety you will lead the US safety strategy for a portfolio of complex high-profile medicines overseeing REMS design product safety governance FDA engagement and risk management execution.

This is a rare opportunity to influence how breakthrough therapies reach patients safely while partnering with senior leaders to shape the future of risk management across the US healthcare landscape.

Job Description

Major accountabilities:

1. REMS Strategy & Leadership

- Lead the US REMS Safety Strategy ensuring alignment with FDA requirements global risk management plans and evolving patient safety priorities.

- Drive development approval and launch of innovative commerciallyfeasibleREMS programs including restricted distribution prescriber/pharmacy certification and patient enrollment systems.

- Provide US input into Risk Management Plans (RMPs) and REMS assessments; ensuring the implementation of recommendations and continuous optimization of risk minimization measures.

2. REMS Operational Oversight

- Manage REMS vendor performance (including call centers specialty pharmacies prescriber certification platforms) to ensure compliance high quality training and robust data integrity.

- Oversee execution of REMS commitments and risk mitigation activities.

3. US Product Safety Strategy

- Oversee US safety related labeling (USPI Medication Guides REMS safety language) and overseetimelyaccuratesubmission of US aggregate reports (e.g. PADERs PBRERs).

- Serve as the primary contact for US product safety inquiries escalations and Health Authority requests.

4. Regulatory Compliance & Quality Oversight

-Maintainreadiness for inspections and audits; manage findings corrective actions and CAPAs to closure.

- Keep current with evolving regulatory requirements and provide insights to support REMS and safety risk management strategy.

-Participatein FDA interactions REMS negotiations advisory boards and industry forums.

Essential Requirements:

- Bachelors degreein Health Care / Life Sciences required; advanced degree preferred (PharmD PhD or MD).

- 10 years of PV leadership experience including risk management planning and operational execution.

- Minimum of 8 years pharmaceutical industry experience is required.

- Strong knowledge of FDA REMS requirements US pharmacovigilance regulations and audit/inspection management.

- Proven leadership communication influencing and decision-making capability.

- Strong executive presence and ability to manage multiple high-priority initiatives.

-Expertiseleading large-scale strategic initiatives related to drug development and regulatory requirements.

- Deep understanding of risk management principles and best practices for REMS implementation.

Desirable Skills:

- Familiarity with safety databases REMS platforms and data analytics tools.

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $204400 and $379600 per year.

The final salary offered isdeterminedbased on factors like relevant skills andexperience andmay be reviewed periodically. Novartis may change the published salary range based on company and market factors. Compensation includesa performance-based cashincentiveand eligibility for annual equity awards.

US-based eligible employees receive a comprehensive benefits package including health life disability benefits 401(k) with companymatch and generous time off.

Join Novartis and play a defining role in advancing patient safety and regulatory excellence in the United now to be part of a purpose-driven organization reimaginingmedicinefor patients worldwide.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$204400.00 - $379600.00

Skills Desired

Clinical Research Clinical Trials Functional Teams (Inactive) Leadership Medical Strategy (Inactive) Process Safety Management Regulatory Compliance Risk Management Safety Science