Head of US Compliance Risk and Assurance (Senior Director)

Responsibilities

• Develop overall strategy for Stemline’s Compliance Risk Assurance function collaborating closely with the Head of US Compliance/Deputy CCO, Legal and other cross functional stakeholders.
• Lead Healthcare Compliance Risk Assessment
• Lead the design and execution of the US Compliance Risk Assessment process to identify, quantify, and prioritize inherent and residual risks
• Lead Compliance Monitoring and Data Analytics
• Develop annual risk-based monitoring plan to include continuous monitoring, periodic deep dives and targeted testing
• Oversee the implementation and optimization of compliance monitoring systems and tools to help the department transition from manual sampling to data-driven monitoring
• Oversee the execution of effective live and transactional monitoring in accordance with annual plan
• Generate monitoring dashboards and analytics to translate complex monitoring data into business analytics that provide actionable insights to senior leadership regarding control effectiveness and compliance trends
• Serve as the primary liaison for Menarini Global Internal Audit; assist with execution of the end-to-end audit lifecycle
• Manage audits of third party vendors
• Create and maintain Investigations Policy and SOP in line with Menarini Global Policies and local ways of working
• Oversee the administration of the Compliance Hotline; ensure whistleblower anonymity, non-retaliation protections, and meticulous documentation
• Oversee investigations of allegations of misconduct in collaboration with Compliance business partners
• Cook up with Global Menarini Compliance on various whistleblower and speakup initiatives
• Oversee Stemline’s Third Party Risk Management Program
• Oversee Stemline’s application of the Menarini Global third-party due diligence framework and related policies and SOPs
• Develop and maintain a compliance program around Global Trade compliance
• Lead Transparency Reporting
• Lead Sunshine and state transparency reporting ensuring high level of accuracy and timeliness in filings
• Manage Personnel and Resources
• Manage, coach and develop assigned staff
• Manage third party resources
• Effectively collaborate across the Stemline and Menarini Compliance teams and cross-functional business and support function stakeholders

Qualifications

• Bachelor degree is required (other advanced degree or course of study strongly preferred)
• Minimum of 10 years of pharmaceutical or biotechnology industry experience developing, implementing and/or managing risk, monitoring, investigations and/or related functions
• Strong working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry
• Unquestioned ethics, judgment, integrity and courage
• Excellent business acumen and highly effective communication skills
• Strong project management and time management skills
• Excellent technical skills and ability to (i) effectively leverage business processes and technology platforms utilized for risk, monitoring, transparency and third party risk management (ii) apply emerging AI technologies to assigned areas of responsibility; and (iii) work effectively in various business tools such as Excel, Powerpoint, Sharepoint, etc.
• Exceptional ability to interpret data sets as they apply to business activities, identify red flag patterns and partner with stakeholders to develop practical solutions
• Solutions-oriented self-starter with balance of strategic vision and tactical skills; ability to work with limited supervision