Associate Director, US Compliance… at MENARINI Group · New York

Associate Director, US Compliance Policy and Training Lead

Location: New York, New York, USA

Company:

0750 Stemline Therapeutics Inc

Contract Type:

Permanent

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.

Reporting the Head of US Compliance and Deputy Chief Compliance Officer, the US Compliance Policy and Training Lead will manage and lead Stemline’s evolving Policy and Training framework. This individual is responsible for navigating within a high-growth, diverse business landscape and has a unique opportunity to shape the future of Stemline’s Compliance function. The successful candidate will blend deep technical expertise with sound judgment to scale Stemline’s compliance policy and training initiatives.

Responsibilities:

Policy Governance

• Develop and maintain Stemline’s Compliance policy governance framework including drafting and maintaining policies and procedures related to policy updates, signing governance and other good policy practices.
• Direct the end-to-end lifecycle of US Compliance policies, including the identification of policy gaps, routine refreshes, and the decommissioning of obsolete guidance.
• Maintain log to capture identified policy and SOP changes resulting from monitoring findings, business feedback, changes in regulations or external environment, etc.
• Develop and oversee digital "home" for policies and ensure policies are mobile-friendly, searchable, and integrated into the daily workflow of the business colleagues
• Lead Policy drafting/editing by capturing feedback from cross functional stakeholders, scheduling meetings to obtain feedback and obtaining necessary signatures on finalized policies
• Develop supplemental policy documents such as reference guides and job aids to aid in policy knowledge and understanding
• Manage Compliance Policy exceptions process
• Maintain Compliance document repository for Policies, Training and other key documents such as committee decks/charters/minutes and Annual Compliance Plan

Training

• Develop and maintain Annual Training and Communications Plan in collaboration with business compliance leads and monitoring/investigations team
• Deploy adult learning principles and utilize AI to develop engaging, relevant and professional trainings for colleagues across the business functions covering a range of compliance topics
• Establish a framework for measuring training effectiveness utilizing training assessments, surveys and and correlation data to measure program efficacy.
• Lead the continuous refresh of training materials to reflect updated laws, guidance, etc.
• Foster a "Speak Up" culture by integrating messaging around the Compliance Hotline and non-retaliation policies into learning and communication touchpoints.
• Oversee the Compliance Learning Management System (LMS) ecosystem, ensuring seamless deployment, meticulous record-keeping in collaboration with QA and Global Compliance Training organization.
• Enhance and maintain employee training matrix to allow for targeted live trainings; coordinate launch of e-learning modules with QA and business stakeholders
• Direct a comprehensive compliance communication strategy utilizing diverse formats —such as "Compliance Minutes," podcasts, micro-learning, and town halls—to keep integrity at the forefront of the corporate conversation.
• Develop and maintain a distinct Compliance Program brand. Create a professional and approachable "voice" for the function that resonates with the corporate culture while fostering a tone of integrity.
• Coordinate training with other functions (QA, IT, HR, etc) and maintain master training calendar
• Develop Compliance program branding to convey professional tone for Compliance function
• Participate in Global Menarini training projects and initiatives as needed

Skills/Knowledge

• Bachelor degree is required (other advanced degree or course of study preferred)
• Minimum of 7 years of pharmaceutical or healthcare industry experience
• Working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry
• Unquestioned ethics, judgment, integrity and courage
• Innovative mindset
• Exceptional communication skills
• Ability to remain flexible, adapt to changing business dynamics and thrive in fast paced environment
• Excellent business acumen, highly effective communication skills and ability to operate effectively within a team and manage expectations of multiple stakeholders
• High level of attention to detail and operational excellence
• Strong project management and time management skills
• Excellent technical skills and ability to work effectively in various business tools such as Excel, Powerpoint, Sharepoint, and Google products as well as systems used to support training, document retention, policies, etc.
• Solutions-oriented self-starter with balance of strategic vision and tactical skills; ability to work with limited supervision

Base Salary Range of $168,985-$210,000. 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.

#LI-Remotee

Base Salary Range of:

168985

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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