Global Medical Affairs Excellence and Project Management Lead (Director) presso Menarini Group

The Global Medical Affairs Excellence & Project Management Lead (Director) will be a key leader within Global Medical Affairs (GMA), responsible for driving operational excellence, strategic planning execution, and developing robust governance and processes. This role will involve partnering with GMA leadership and cross-functional teams to enhance capabilities, optimise operations, and ensure compliant and effective execution of strategic initiatives across the portfolio. The incumbent will act as a key thought partner and trusted advisor to the Head of Medical Affairs and the leadership team.

• Operational Planning & Execution:
• Partner with the Medical Affairs leadership team to develop GMA strategic initiatives and lead the execution of GMA tactical plans.
• Ensure initiatives being led by, or impacting, GMA are appropriately surfaced, prioritized, resourced, and executed.
• Identify, prioritize, and advance Global/Regional Medical Affairs initiatives and key execution deliverables across the portfolio; monitor progress and communicate updates.
• Coordinate and optimise the quarterly/annual planning processes.
• Support the Head of Medical Affairs in the oversight of strategic planning and setting metrics.
• Operational Excellence & Process Improvement:
• Oversight of GMA operational excellence and quality key performance indicators (KPIs).
• Analyse and assess GMA capabilities, processes, and systems to identify gaps within GMA to maximise value, operational efficiency, and compliance aligned with strategic priorities.
• Work with GMA operational leadership to identify, manage, and coordinate the GMA LT cross-functional process-improvement and business initiatives.
• Identifies, optimises, and codifies key GMA departmental processes.
• Identify best practices across Medical Affairs functions globally and identify areas that can be improved.
• Lead or participate in the development of planning tools, templates, processes to support Medical Affairs.
• Governance & Compliance:
• Key role in the establishment of a Global Medical Affairs organization, along with global and regional department policies and practices.
• Develops and works to continually improve Medical Affairs’ governance and infrastructure, including development of SOPs, best practices, as well as training and workshops of MA associates.
• Accountable for MA Compliance initiatives, policy interpretations, risk mitigation, trainings, and corrective actions, in collaboration with compliance and clinical QA functions.
• Partner and collaborate with various line functions such as Legal and Compliance to simplify business processes and minimise risk of non-compliance.
• Leadership & Collaboration:
• Collaborate across key line functions to build fully integrated MA plans.
• Work with the GMA leadership team to identify key cross-functional interdependencies and optimise those working relationships and routines.
• Drives effective communications and execution within GMA and with key stakeholders across the organisation.
• Act as representative for the Head of Global Medical Affairs in appropriate meetings to gather information, provide input and facilitate efficient decision making.
• Ensures communications, processes and resources aligned across organizations.
• Work with GMA leadership to manage and set the Global Medical Affairs leadership team agendas, ensure effective meeting facilitation, action management and follow up.
• Ensure distillation of key metrics, achievements, issues, risks, mitigation plans are on the LT’s radar screen.
• Manage the compilation of Medical Affairs department goals and track performance against goals.
• Financial & Resource Management:
• Lead budget planning for Global Medical Affairs and supportive functions
• Collaborate with individual functional teams to coordinate development of budgets for medical plans, brand plans, and tactical plans.
• Provide medical input and management of budgets for MA programs, including clinical grants and medical education support activities.
• Support the Head of Medical Affairs in the oversight of budgeting.
• Be involved in the regular GMA finance-related GMA processes, such as workforce/headcount and space planning activities, to identify trends and actions from data review and discussion.

• Bachelor’s Degree in a science related area is a minimum; MSc, MBA, or doctoral degree is preferable.
• Minimum of 10 years of experience in direct project management, working in Medical Affairs, Drug Development or Clinical Research.
• Demonstrated ability in strategic planning, resource management and budget reporting.
• Demonstrated success working in a fast-paced, matrixed, growing organization; successful in partnering with multiple internal & external stakeholders.
• Possesses an understanding of drug development process and clinical trials, with basic knowledge of oncology and/or hematology preferred.
• Understanding of Medical Affairs projects (e.g. clinical trials, medical brand plan preparation) preferred.

• Proficient at multitasking on multiple ongoing projects, with agility to course adjust/modify, and remain highly detailed oriented with timely deliverables.
• Able to operationally function and communicate in a global, cross-functional, matrix organization across various teams.
• Able to adapt behavior to situation, to influence outcomes without direct authority and to hold oneself and others accountable for commitments in a productive, collaborative and assertive manner.
• Excellent written, oral communication and strong organizational skills.
• Demonstrated internal and external customer focus orientation & credibility.
• Computer and systems literate; strong knowledge of MS Office, including Word, Excel, PowerPoint, and Outlook.
• Experience in planning systems and project management tools (e.g. MS project).
• Demonstrated ability to present complex issues to upper-level management and contribute to executive level presentations and discussions.
• Excellent and demonstrated interpersonal skills: ability to understand and respond to multiple external and internal customers’ demands, manage and handle conflict constructively required.
• Strong ability to toggle quickly between strategy and details.
• Ability to handle confidential information with discretion.
• Self-starter who identifies and helps solve problems and is comfortable with ambiguity

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 $215,000-$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.