Associate Director, Third-Party Compliance

Company: 0750 Stemline Therapeutics Inc

Contract Type:

Join us in shaping the future of Menarini - with passion, integrity, and a deep commitment to people.

About Menarini Group - Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. For more than 135 years, we have worked to improve patients’ lives across a broad range of therapeutic areas through our dedication to science, integrity, and care for people. With a strong foundation in scientific excellence and a purpose-driven culture, Menarini offers diverse career opportunities for professionals eager to make a meaningful impact on global health.

Stemline Therapeutics, Inc. is seeking an Associate Director of Third Party Compliance to join our growing team. The position will report directly to the Senior Director of US Compliance Risk Assurance to lead the operational execution and continuous improvement of Stemline’s third-party risk management framework. This position will support the Compliance Risk

Assurance group in building and maintaining an effective compliance program through implementation of effective risk control measures.

Responsibilities:

Third-Party Risk Strategy and Oversight

• Own and continuously refine the U.S. Third-Party Risk Management strategy and governance ensuring alignment with global compliance standards and evolving regulatory expectations.
• Serve as the primary compliance advisor on high-risk third-party engagements, conducting appropriate diligence, evaluating red flags, driving risk mitigation strategies, coordinating remediation steps with Legal and business stakeholders, and securing executive approvals to executive leadership

HCP Engagement Systems & Operational Support

• Lead the support the cross-functional evaluation, rollout and post-implementation support of a global HCP engagement platform in close partnership with IT and key business stakeholders.

• Lead change management efforts, deliver end-user training, and serve as the operational subject matter expert for HCP engagement workflows.

Transparency & Regulatory Reporting

• Provide strategic governance and operational oversight for HCP US State and Federal transparency reporting.
• Direct vendor management activities to ensure accurate, timely preparation, validation, and submission of state and federal transparency reports (e.g., CMS Open Payments).
• Implement data integrity checks across all reporting feeds, collaborating with business owners to resolve spend disputes and reconciliation discrepancies.
• Maintain CMS audit readiness by developing, refining, and executing comprehensive compliance audit plans.
• Develop and present regular transparency and third-party risk metrics, audit findings, and compliance dashboards to the U.S. and Global Compliance Committees and executive stakeholders.

Special Projects: Carry out additional risk and compliance responsibilities as assigned.

Skills/Knowledge:

• Bachelor’s degree is required Advanced degree (J.D., MBA, or MS) or compliance certification (e.g., CCEP, CFE) is preferred).
• Minimum of 7+ years in U.S. healthcare compliance, ethics, or legal, with at least 3–5 years focused specifically on third-party risk, transparency (Open Payments), and HCP engagement governance
• Executive presence, ability to work effectively in a matrix organization and effective vendor management is essential.
• Possess strong working knowledge of pharmaceutical or biotechnology industry regulatory requirements, i.e., Anti-Kickback Statute, Food Drug & Cosmetic Act (FDCA), the Pharmaceutical Research and Manufacturers of America (PhRMA) Code, the Physician Payment Sunshine Act (Open Payments) and the various State transparency laws
• Excellent analytical skills and ability to synthesize large data sets
• Strong communication skills and the ability to effectively collaborate with key stakeholders
• Excellent organization and time management skills with ability to handle multiple responsibilities simultaneously
• High degree of self-motivation and ability to execute responsibilities with minimal supervision

Base Salary Range of $178,550 - $216,000. Menarini Stemline offers generous compensation and benefits packages, including Short and Long-Term Incentive Programs, Fidelity 401(k) (with company match of 6%), PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

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.

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.

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Base Salary Range of:

Menarini Stemline offers generous compensation and benefits packages, including Fidelity 401(k) (with company match), Healthcare insurance, 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.

The Company

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.

Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey.

In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.

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.

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