Head of Field Medical Affairs-US

Overview

Head of Field Medical Affairs-US

Reports to VP, US Medical Affairs

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.

Job Summary: The Head of US Field MSLs & CVELs will lead and manage the US Field Medical Science Liaison team and Clinical Value Evidence Liaison team, ensuring the effective execution of field medical strategies and activities. This role is pivotal in establishing and maintaining scientific relationships with key opinion leaders (KOLs) and healthcare professionals (HCPs) to support the company's medical and scientific objectives.

Responsibilities

Leadership & Management:

• Lead, mentor, and develop a team of Field MSLs and CVELs across the United States.
• Oversee the translation of Medical Affairs strategies into actionable field medical initiatives and ensure successful execution by working with Medical Affairs Strategy team (MST), in alignment with other key internal stakeholders.
• Foster a collaborative and high-performance culture within the team.
• Participate in relevant cross-functional teams and task forces to represent the US Medical Affairs team as needed. Make presentations to colleagues and senior management as needed.
• Provide on-going coaching and talent development of direct reports and entire field medical team through assessment of competency and feedback from peers
• Own the assessment of new hire candidates' scientific and technical expertise as well as develop organizational talent for future leadership positions
• Plan, coordinate and execute monthly virtual national meetings and face to face meetings for field medical teams

Strategic Planning:

• Develop and implement field medical plans and strategies in collaboration with cross-functional teams.
• Identify and advance novel ideas for tactics, resources and training to cross-functional partners; lead or partner cross-functionally on pull through of aligned tactics and resources
• Identify opportunities for cross-functional integration of MSL roles and activities.
• Provide strategic insights and recommendations based on field observations and interactions; create and share trimesterly MSL insights and action reports cross-functionally.

Scientific Engagement:

• Define KOL mapping and engagement strategy for the portfolio of brands in collaboration with MAST
• Establish and maintain relationships with KOLs and HCPs to support scientific exchange and gather insights.
• Ensure the team effectively communicates scientific data and information to external stakeholders.
• Represent the company at scientific conferences, meetings, and other events.

Compliance & Reporting:

• Ensure all field activities comply with regulatory and company policies.
• Monitor and report on field activities, performance metrics, and outcomes.
• Provide regular updates to senior leadership on field medical activities and insights.
• Participates in discussions regarding the creation of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives and for complying with government regulations and company policy. Ensures adherence to policies/procedures
• Provide guidance and counsel to associates and others, as necessary, to ensure that all activities are legally compliant and conducted according to Company policies, procedures and standards
• Performs other responsibilities as requested by management

Qualifications

• Advanced scientific degree (MD, PharmD, PhD) required.
• Minimum of 10-15 years of experience in a field-based medical role, with at least 5 years in a leadership position, ideally leading both teams and team leaders.
• Strong understanding of the pharmaceutical or biotechnology industries.
• Industry experience in oncology required; experience in breast cancer preferred.
• Excellent leadership, communication, and interpersonal skills.
• Ability to travel up to 50% of the time.
• Must have a "roll-up their sleeves" work style understanding both tactical and strategic work are requirements.
• Capable of working within a team structure. Teamwork is a mandatory requirement; excellent collaboration, presentation, and communication skills (both written and oral) required.
• Able to compliantly collaborate with marketing and sales leaders post launch to disseminate critical information.
• Strong organizational skills, attention to detail, ability to prioritize and meet deadlines.
• Excellent problem-solving ability in concert with strong negotiation skills.
• Passionate about making a meaningful difference in a patient or caregivers' life.
• Ability to motivate others.

Preferred Skills:

• Experience in multiple therapeutic areas, including breast cancer and myeloid malignancies.
• Proven track record of successful team management and development.
• Strong analytical and strategic thinking abilities.

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.

Base Salary Range of $325,000-$370,000. Menarini Stemline offers generous compensation and benefits packages including Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, 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.