Medical Director, Clinical Development, Hematologic Malignancies

Overview

The Medical Director, Clinical Development, Hematologic Malignancies will serve as a Medical Monitor for post-marketing studies. This is a critical, hands-on role requiring deep expertise in hematologic malignancies, including AML and MDS. The successful candidate will focus on the day-to-day medical oversight of complex combination and basket trials, ensuring study integrity through rigorous eligibility reviews and real-time data interpretation.

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.

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Responsibilities

• Serve as the Lead Medical Monitor; provide medical oversight, perform real-time eligibility reviews, and address investigator inquiries for post-marketing trials.

• Contribute to the practical design, implementation, and long-term strategy of clinical protocols. Translate scientific objectives into operational study designs for complex trials, identifying optimal development pathways, expansion opportunities, and competitive positioning to maximize the asset's clinical value.

• Contribute to the Clinical Review process; conduct continuous review and interpretation of accumulating safety/efficacy data and manage SAE reporting in compliance with global regulations.

• Contribute to the medical contribution to and provide clinical oversight for INDs, NDAs/BLAs, Investigator Brochures (IBs), and Clinical Study Reports (CSRs).

• Partner with Clinical Operations to hit enrollment targets and Discovery teams to design translational strategies; act as the clinical lead for Business Development/due diligence activities.

• Act as the primary liaison for Key Opinion Leaders (KOLs) and investigators; represent the company at major congresses (ASH, ASCO, EHA).

• Ensure all trial activities strictly adhere to GCP, ICH guidelines, and internal SOPs.

• Manage the assessment and reporting of Serious Adverse Events (SAEs) in compliance with global regulations.

• Act as the clinical expert for the study, ensuring sites adhere to the medical and scientific nuances of the protocol.

• Collaborate with Clinical Scientists on the analysis and reporting of scientific content.

• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific, clinical and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes to partnership with Discovery colleagues to design and implementation of clinical translational strategies.

• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Menarini-Stemline at key external meetings.

Qualifications

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship (in heme-onc) is desirable.

• Minimum of 3 years of industry experience. Preferred 5+ years Oncology experience in Biotech/Pharma industry.

• Clinical trial experience with relevant classes of agents in the pharmaceutical industry, academia, or equivalent.

• Ability to run a complex clinical research program independently.

• Ability to support a global scientific and business strategy.

• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.

• Must possess excellent oral and written English communication skills, including presentation skills

• Ability to exercise judgment and address complex problems and create solutions for one or more projects.

• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.

• Proven ability in establishing and maintaining cross-functional relationships with a wide range of internal and external stakeholders

• Critical thinking skills with unique problem-solving abilities for new and novel obstacles

• Excellent strategic planning abilities

• Willingness to travel

• Strong analytical skills, especially regarding understanding and interpreting scientific and clinical research and literature, are essential

Base Salary Range of $289,000-$342,000. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, 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.

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 license 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.

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.