Senior Manager, Scientific Excellence, Medical Affairs

Overview

Job title - Sr. Manager, Scientific Excellence, Medical Affairs
Reports to - Director, US Medical Affairs Operational Excellence

The Sr. Manager, Scientific Excellence, Medical Affairs will be responsible for supporting US Medical Affairs scientific communication activities, with a primary focus on congress planning, publication support (specifically ENCOREs), and the development of scientific presentations and slide decks. This position will assist in the execution of the US publication strategy and contribute to the US congress strategy, ensuring alignment with both Global Medical teams and the US Medical Strategy Teams (MST).

Responsibilities

Congress Strategy & Execution:

• Contribute to the US Congress strategy and lead content development for resources intended for key US congresses (i.e., AACR, ASH, SABCS, ASCO) and select regional congresses.
• Support the Medical Affairs booth strategy, including leading meetings, overseeing booth rendering, and coordinating creative content creation like videos and animations.
• Manage planning and coordination for regional congresses and symposia, including Knowledge Bar planning and managing regional displays.

Publication Support (Encores):

• Support the development and execution of the US publication strategy.
• Focus on planning data encores (posters, presentations) tailored for specific congress audiences, including RWE and clinical data.
• Identify new congresses and opportunities for poster presentations to disseminate scientific data.

Scientific Content & Slide Development:

• Provide scientific and PRC (Promotional Review Committee) support for the development of slides for advisory boards and symposia and other engagements as needed.
• Support the PRC review process for slides, surveys, and invitations related to advisory and scientific meetings.
• Collaborate with internal teams to build medical resources, such as videos and animations, for use at congresses and other media platforms.
• Plan and expand collaboration with state societies for dissemination of scientific data and clinical trial listings at conferences and through available digital channels such as newsletters, websites, podcasts etc.

Qualifications

• An advanced life science degree (PhD, PharmD, or MD/DO) is highly preferred
• A Master's level degree in a related discipline may be considered based on relevant experience
• Minimum 3 years in the Pharma/Biotech industry, with experience in a similar role highly preferred
• Oncology experience is highly preferred
• Prior 3rd party medical communication agency experience is preferred
• Substantial expertise in scientific communication strategy and medical education activities is preferred
• Demonstrated ability to support strategic publication planning and the development of medical education materials
• Significant experience with publication development, writing, and management for medical publications is required
• 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.
• 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 an equal opportunity employer. We celebrate diversity and are 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 individuals with disabilities to perform the essential functions.

Base Salary Range of $141,000-$180,000. 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.

ABOUT US

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.