Homeoffice US Medical Excellence & Operations Lead (Associate Director/Director) bei Menarini Group

US Medical Excellence & Operations Lead (Associate Director/Director)

Reports to VP, Head of US Medical Affairs

Opportunity

The US Medical Excellence & Operations Lead will play a critical role in supporting high levels of performance by the US Medical Affairs team and elevating the voice of medical affairs to Menarini Stemline Senior Leadership.  This role will lead the US Medical Excellence & Operations function and may directly oversee members of the operations team.  This role will partner with internal stakeholders, including the US Field Medical Lead, Regional Directors of MSLs, Clinical Value & Evidence team lead and Strategic Operations, and the HQ strategy team, to create a climate in which self-motivated individuals will aspire to higher levels of performance.

The incumbent supports development of the US medical teams with training, change management, communications, best practice measurement of activity and impact. S/he will collaborate with Medical Affairs Leadership to communicate US medical affairs impact to leadership via analytics and insights reporting.  S/he will identify and develop continuous skill and scientific acumen training to enhance scientifically credible, confident, effective, and aligned engagements with the medical community.

Strategic Planning & Operational Leadership

• Develop and lead the strategic roadmap for US Medical Affairs operational excellence, aligned with US strategy and business objectives.
• Design, implement, and maintain standardized operating procedures (SOPs), workflows, and best practices across all core Medical Affairs functions (e.g., Medical Science Liaisons (MSL), Medical Information, Investigator-Initiated Trials (IITs), Grants, Publication Planning).
• Drive continuous improvement initiatives to optimize resource utilization, reduce operational friction, and enhance the quality and impact of scientific engagements.
• Oversee and manage key platforms and technologies critical to Medical Affairs operations (e.g., CRM for MSLs, content management systems, insights aggregation tools & analytics dashboards).
• Conduct benchmarking assessment for US medical affairs as needed
• Monitor industry Medical Affairs best practices and provide recommendations for process improvement, engagement innovation, training delivery and technology needs across field medical excellence topics
• Depending upon experience, may serve as the head of the US Medical Excellence & Operations team, providing direct oversight & management of team members

Performance, Metrics, & Insights

• Establish and monitor key performance indicators (KPIs) and metrics to measure the effectiveness and impact of Medical Affairs activities and operational efficiency.
• Lead the development of standardized reporting and dashboards to provide actionable insights to Medical Affairs leadership for strategic decision-making.
• Conduct operational reviews and gap analyses to identify areas for improvement and implement necessary changes.

Governance & Compliance

• Partner closely with Legal, Regulatory, and Compliance departments to ensure all US Medical Affairs operations, processes, and systems adhere to federal, state, and industry regulations (e.g., FDA, PhRMA Code) and internal company policies.
• Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness
• Manage the training strategy for operational excellence and compliance for the US Medical Affairs team.

Cross-Functional Collaboration & Training

• Act as the primary liaison between US Medical Affairs and cross-functional partners, including Global Medical Excellence, Commercial Operations, R&D, and IT.
• Lead the development and execution of training programs on new processes, technologies, and operational best practices for the US Medical Affairs team.
• Foster a culture of continuous improvement, data-driven decision-making, and high-quality execution within the Medical Affairs organization.
• Identify training needs, including compliance and soft skill training, and facilitate delivery of training to personnel
• Liaise with scientific training content expert(s) in creation of tailored field medical tools/resources to ensure a continuous high standard of scientific acumen for the US medical affairs team

• Advanced medical and/or scientific degree (e.g., MD / DO, PhD, PharmD, PA, RD, MSc, NP) - Doctorate level training highly preferred
• Minimum of 7-10 years of progressive experience within the pharmaceutical or biotech industry, with at least 3 years in Medical Affairs Excellence/Operations or a similar strategic/enabling role.
• Oncology experience preferred
• Strategic Thinking: Ability to translate high-level business goals into practical, executable operational plans.
• Leadership & Influence: Exceptional ability to lead complex projects, influence stakeholders at all levels, and drive organizational change without direct reporting authority.
• Analytical Rigor: Proficient in data analysis, reporting, and utilizing metrics to drive improvements.
• Communication: Excellent verbal, written, and presentation skills.
• Detail-Oriented: Meticulous attention to detail with an unwavering focus on quality and compliance.
• Incumbent must have track record of working well in a dynamic environment and enjoy working with different stakeholders (clinical, pre-clinical, external customers, etc.)
• Knowledge and understanding of clinical priorities for different healthcare professionals including physicians, nurses, pharmacist, researchers and research associates
• Stellar record of being successful in fast-paced, dynamic environment, self-motivated, works with limited supervision
• Must have a “roll-up their sleeves” work style understanding both tactical and strategic work are requirements.
• Capability to work independently or in a team structure and, to adjust effectively to work within new structures, processes, requirements, or cultures.
• Teamwork is a mandatory requirement; excellent collaboration, presentation, and communication skills (both written and oral) required.
• Demonstrated budget and resource management skills
• Remote Position with Travel 20-30% as needed

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

Base Salary Range of $165,000-$255,000.  Menarini Stemline offers generous compensation and benefits packages,  including Short- and Long-Term Incentive Programs,  Fidelity 401(k) (with 6% company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

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.