Overview

Head of US Compliance and Deputy Chief Compliance Officer (Executive 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 and Deputy CCO leads Stemline’s US Compliance program and serves as the primary strategic partner to Stemline’s US business. This senior leadership role is responsible for navigating the compliance needs of a high-growth, diverse business landscape. The role provides a unique opportunity to support the US business while 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

• Leverage knowledge of industry guidance, laws, codes and best practices to direct the design, implementation, and evolution of a comprehensive US Compliance Program, ensuring alignment with the OIG and DOJ guidelines

• Proactively plan for emerging trends in compliance, anticipating the impact of these trends 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 to empower Company personnel to manage risk with clarity, integrity and sound judgement

• Lead the development and maintenance of a US policy framework designed to establish clear, comprehensive and effective policies and procedures to aid the business in efficient decision making. Oversee initiatives to enhance policy accessibility

• Establish effective business processes and controls to ensure the Company is complying with its legal and regulatory obligations and undertake a continuous improvement process to timely identify and remediate any program gaps

• Set an appropriate tone of integrity and raise awareness of compliance as a collective responsibility of all Company personnel through effective engagement, training, auditing, and monitoring

• Partner with Head of Compliance Risk and Assurance to (i) identify monitoring needs, provide support for live monitoring and pull through monitoring results/analytics to business stakeholders; (ii) conduct planning and inputs for risk assessments; (iii) support annual transparency reporting; and (iv) 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

Qualifications

• 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 with 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 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: (i) business processes and technology platforms utilized for transparency reporting, fair market value assessments, and e-learning; (ii) emerging AI technologies; and (iii) business tools such as Excel, Powerpoint, etc.

• Solutions-oriented self-starter with balance of strategic vision and tactical skills; ability to work with limited supervision

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $263,001-$360,926. 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.