Role Description
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:
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Third-Party Risk Strategy and Oversight:
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Own and continuously refine the U.S. Third-Party Risk Management strategy and governance ensuring alignment with global compliance standards and evolving regulatory expectations.
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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.
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HCP Engagement Systems & Operational Support:
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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.
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Lead change management efforts, deliver end-user training, and serve as the operational subject matter expert for HCP engagement workflows.
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Transparency & Regulatory Reporting:
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Provide strategic governance and operational oversight for HCP US State and Federal transparency reporting.
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Direct vendor management activities to ensure accurate, timely preparation, validation, and submission of state and federal transparency reports (e.g., CMS Open Payments).
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Implement data integrity checks across all reporting feeds, collaborating with business owners to resolve spend disputes and reconciliation discrepancies.
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Maintain CMS audit readiness by developing, refining, and executing comprehensive compliance audit plans.
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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.
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Special Projects:
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Carry out additional risk and compliance responsibilities as assigned.
Qualifications
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Bachelor’s degree is required.
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Advanced degree (J.D., MBA, or MS) or compliance certification (e.g., CCEP, CFE) is preferred.
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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.
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Executive presence, ability to work effectively in a matrix organization and effective vendor management is essential.
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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.
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Excellent analytical skills and ability to synthesize large data sets.
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Strong communication skills and the ability to effectively collaborate with key stakeholders.
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Excellent organization and time management skills with ability to handle multiple responsibilities simultaneously.
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High degree of self-motivation and ability to execute responsibilities with minimal supervision.
Benefits
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Base Salary Range of $178,550 - $216,000.
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Generous compensation and benefits packages, including:
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Short and Long-Term Incentive Programs.
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Fidelity 401(k) (with company match of 6%).
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PPO and HDHP insurance plans.
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Company paid Basic Life & AD&D insurance.
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Pre-tax FSA/HSA programs.
Company Description
Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. Founded in 1886 in Naples, Menarini moved to Florence in 1915 where the Group’s headquarters are still located today. The company is present in 70 countries and its products are sold in 140 locations around the world.
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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.
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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.