Head of US Compliance Risk and Assurance (Senior Director)

Menarini Group•, NY

71d•$215,000 - $268,551

About The Position

The Head of US Compliance Risk And Assurance serves as the lead for Stemline’s Risk Assessment, Monitoring, Investigations and Transparency Compliance activities. This senior leadership role is responsible for navigating the risk assurance needs of a high-growth, diverse business landscape and has a unique opportunity to shape the future of Stemline’s US Compliance function while also acting as a leader within Menarini’s Global Compliance organization. The successful candidate will blend deep technical expertise with sound judgment to scale Stemline’s compliance program.

Requirements

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
Ability to mentor and retain a high-performing team of compliance professionals, fostering a culture of continuous learning and professional accountability
Strong working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry
Unquestioned ethics, judgment, integrity and courage
Ability to remain flexible, adapt to changing business dynamics and thrive in fast paced environment
Excellent business acumen and highly effective communication skills
Strong project management and time management skills
Ability to work collaboratively by engaging stakeholders across all levels of the organization
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

Nice To Haves

other advanced degree or course of study strongly preferred

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
Lead Investigations Systems and Processes
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
Coordinate 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
Transparency Reporting
Lead Sunshine and state transparency reporting ensuring high level of accuracy and timeliness in filings
Act as the subject matter expert around transparency reporting requirements
Management of 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