Head of US Compliance Risk and Assurance (Senior Director)

Overview

Head of US Compliance Risk and Assurance (Sr. Director)

Reports to Chief Compliance Officer, Oncology

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.

Opportunity

Reporting directly to the Chief Compliance Officer, Oncology, 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.

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. Specific responsibilities include:

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

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
• 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

Base Salary Range of $215,000-$268,551. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.