Head of US Compliance and Deputy Chief Compliance Officer

Menarini Group•, NY

71d•$263,001 - $360,926•Remote

About The Position

The Head of US Compliance and Deputy Chief Compliance Officer (Executive Director) reports to the Chief Compliance Officer, Oncology. Menarini Group is an Italian pharmaceutical company with a long history, focused on high-quality therapeutics, ethics, innovation, people-centricity, and environmental sustainability. The Group has a global presence and has entered the US oncology market through the acquisition of Stemline Therapeutics. Menarini has a strong commitment to oncology, with investments in pipeline compounds and strategic acquisitions to enhance its portfolio. This role offers a unique opportunity to support the US business while acting as a leader within Menarini’s Global Compliance organization, blending technical expertise with sound judgment to scale the compliance program.

Requirements

Bachelor degree is required (a JD or other advanced degree or course of study strongly preferred).
Minimum of 12 years of broad compliance experience in the pharmaceutical or biotechnology industry.
At least 5 years in a senior leadership position.
Exceptional working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry.
Ability to mentor and retain a high-performing team of compliance professionals, fostering a culture of continuous learning and professional accountability.
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 written and oral communication skills.
Strategic vision combined with hands-on, solutions-oriented approach.
Ability to work collaboratively by engaging stakeholders across all levels of the organization.
Strong technical skills with working knowledge of business processes and technology platforms utilized for transparency reporting, fair market value assessments, and e-learning.
Working knowledge of emerging AI technologies.
Working knowledge of business tools such as Excel, Powerpoint, etc.
Solutions-oriented self-starter with a balance of strategic vision and tactical skills.
Ability to work with limited supervision.

Responsibilities

Direct the design, implementation, and evolution of a comprehensive US Compliance Program, ensuring alignment with OIG and DOJ guidelines.
Proactively plan for emerging trends in compliance, anticipating their impact on Company processes and controls.
Serve as a strategic advisor to Commercial, Medical Affairs, Patient Advocacy, R&D, and other teams to enable innovation while proactively addressing compliance risks.
Partner with cross-functional stakeholders to understand changing business practices, identify risks, and adapt Compliance program elements to address emerging risks.
Chair the US Compliance Committee and provide regular updates to the Chief Compliance Officer, Oncology on program effectiveness, risk profiles, and mitigation strategies.
Lead the strategic development and implementation of a practical and business-oriented compliance training and communication program.
Lead the development and maintenance of a US policy framework designed to establish clear, comprehensive, and effective policies and procedures.
Oversee initiatives to enhance policy accessibility.
Establish effective business processes and controls to ensure compliance with legal and regulatory obligations and undertake a continuous improvement process to identify and remediate program gaps.
Set an appropriate tone of integrity and raise awareness of compliance as a collective responsibility through effective engagement, training, auditing, and monitoring.
Partner with Head of Compliance Risk and Assurance to identify monitoring needs, provide support for live monitoring, and pull through monitoring results/analytics to business stakeholders.
Provide planning and inputs for risk assessments.
Support annual transparency reporting.
Support internal investigations.
Partner with business stakeholders in connection with the preparation of an annual compliance work plan.
Support various enterprise-wide initiatives led by Menarini’s Global Compliance function.
Manage, coach, and develop assigned staff and third-party resources.