Senior Director, Global Medical Affairs, Solid Tumors

Stemline Therapeutics; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior/Executive Director for Global Medical Affairs focusing on Solid Tumors. This pivotal role requires an MD or Ph.D. with extensive experience in clinical development and a track record in oncology. You will shape the pipeline, drive critical studies, and collaborate with cross-functional teams to ensure high-quality execution of clinical trials, playing an integral part in advancing innovative cancer therapies.

Qualifications

• At least 5 years of clinical development experience in the pharmaceutical industry.
• Ability to manage clinical trials from a medical/scientific perspective.
• Experience in Breast Cancer (Oncology).

Responsibilities

• Lead clinical data generation strategy and execution for trials.
• Gather clinical/medical/scientific insights to optimize trial implementation.
• Identify and engage qualified investigators.

Skills

Excellent communication skills

Stakeholder engagement

Understanding of regulatory requirements

Agility in therapeutic areas

Clinical trial management

Education

MD

Ph.D.

Job description

Overview

Senior/Executive Director, Global Medical Affairs, Solid Tumors

Reports to VP, Head of Global Medical Affairs

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.

Responsibilities

This pivotal (Senior/Executive) Director - Solid Tumours Global Medical Affairs role will focus specifically on Solid Tumors and play a critical part in shaping our pipeline strategy and maximizing the lifecycle of our assets.

You will be instrumental in driving our investigator-sponsored / collaborations studies strategy, ensuring the generation of robust data to support both early and late-stage clinical development. You will bring a proactive approach, actively seeking out opportunities and engaging with investigators and sites to foster strong partnerships and gain valuable insights.

Reporting to the Vice President and Head of Global Medical Affairs - Solid Tumors, you will operate at a global level, collaborating cross-functionally with Clinical Development, Clinical Operations, Biostatistics, clinical Pharmacology, Preclinical and Translational Medicine, Regulatory Affairs, Safety, Pharmacovigilance, Access and Commercial teams. Your deep understanding of the solid tumors landscape, coupled with your strategic thinking and proactive engagement style, will be crucial in driving our success.

Responsibilities include, but are not limited to:

• Lead clinical data generation strategy and execution for collaboration and independent research programs/trials.
• Gather clinical/medical/scientific insights to optimize trial implementation.
• Identify and engage qualified investigators with strong recruitment potential.
• Ensure adherence to safety standards and maintain high-quality clinical data.
• Collaborate with cross-functional teams to support successful trial execution.
• Provide clinical/medical expertise to support trial feasibility, ethics approvals, and site selection.
• Ensure compliance with regulatory standards, GCP, and internal policies.
• Act as a scientific/clinical/medical expert in interactions with medical experts.
• Support safety monitoring, pharmacovigilance, and risk mitigation in trials.

Qualifications

Essential Requirements:

• MD., Ph.D. required
• At least 5 years of clinical development experience in the pharmaceutical industry in medical affairs / clinical development
• Demonstrate an understanding of regulatory requirements and policies, procedures, and guidelines pertaining to clinical trials.
• Ability to manage clinical trials from a medical/scientific perspective
• Excellent communication and stakeholder engagement skills
• Agility to work across different therapeutic areas
• Proficiency in English and local language
• Ability to travel
• Experience in Breast Cancer (Oncology)

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

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