Senior Director, Head of US Compliance Risk Assurance

MENARINI Group•New York, NY

1d•$215,000 - $268,551•Remote

About The Position

The Head of US Compliance Risk and Assurance leads Stemline’s compliance risk assessment, monitoring, investigations, transparency, and third-party risk activities. Reporting directly to the Chief Compliance Officer, Oncology, this senior leadership role develops and scales the US Compliance Risk Assurance function in a high-growth business and contributes as a leader within Menarini’s Global Compliance organization. The role collaborates closely with the Head of US Compliance/Deputy CCO, Legal, and cross-functional stakeholders. The position sets the strategy for healthcare compliance risk assessment and data-driven monitoring; oversees monitoring systems, plans, execution, dashboards, and analytics; and serves as the primary liaison to Menarini Global Internal Audit. It leads investigations policies and processes, hotline administration, misconduct investigations, and coordination on whistleblower initiatives. The role also oversees third-party due diligence and global trade compliance, leads Sunshine and state transparency reporting, and manages and develops assigned staff and third-party resources.

Requirements

Bachelor’s degree required.
Minimum of 10 years of pharmaceutical or biotechnology industry experience developing, implementing, and/or managing risk, monitoring, investigations, or related functions.
Ability to mentor and retain a high-performing team of compliance professionals and foster continuous learning and professional accountability.
Strong working knowledge of laws, regulations, and industry guidance affecting the pharmaceutical industry.
Unquestioned ethics, judgment, integrity, and courage.
Ability to remain flexible, adapt to changing business dynamics, and thrive in a fast-paced environment.
Excellent business acumen and highly effective communication skills.
Strong project management and time management skills.
Ability to collaborate and engage stakeholders across all levels of the organization.
Excellent technical skills and ability to leverage business processes and technology platforms for risk, monitoring, transparency, and third-party risk management; apply emerging AI technologies to assigned areas; and work with tools such as Excel, PowerPoint, and SharePoint.
Exceptional ability to interpret data sets in relation to business activities, identify red-flag patterns, and partner with stakeholders to develop practical solutions.
Solutions-oriented self-starter with strategic vision and tactical skills, able to work with limited supervision.

Nice To Haves

An advanced degree or other course of study is strongly preferred.

Responsibilities

Develop the overall strategy for Stemline’s Compliance Risk Assurance function in collaboration with the Head of US Compliance/Deputy CCO, Legal, and cross-functional stakeholders.
Lead the design and execution of the US Compliance Risk Assessment process to identify, quantify, and prioritize inherent and residual risks.
Develop an annual risk-based monitoring plan that includes continuous monitoring, periodic deep dives, and targeted testing.
Oversee implementation and optimization of compliance monitoring systems and tools to shift from manual sampling to data-driven monitoring.
Oversee live and transactional monitoring in accordance with the annual plan.
Generate monitoring dashboards and analytics that provide senior leadership with actionable insights into control effectiveness and compliance trends.
Serve as the primary liaison for Menarini Global Internal Audit and assist with the end-to-end audit lifecycle.
Manage audits of third-party vendors.
Create and maintain investigations policies and SOPs aligned with Menarini Global Policies and local ways of working.
Oversee the Compliance Hotline, including whistleblower anonymity, non-retaliation protections, and meticulous documentation.
Oversee investigations of alleged misconduct in collaboration with Compliance business partners.
Coordinate with Global Menarini Compliance on whistleblower and speak-up initiatives.
Oversee Stemline’s Third Party Risk Management Program and its application of Menarini’s global third-party due diligence framework, policies, and SOPs.
Develop and maintain a compliance program for Global Trade compliance.
Lead Sunshine and state transparency reporting, ensuring accurate and timely filings, and serve as the subject matter expert on transparency reporting requirements.
Manage, coach, and develop assigned staff and manage third-party resources.
Collaborate across Stemline and Menarini Compliance teams and with cross-functional business and support-function stakeholders.