Medical Director, Clinical Development, Hematologic Malignancies

This is a critical, hands-on corporate office role requiring deep expertise in hematologic malignancies, including AML and MDS. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of work location.

About the role

The Medical Director, Clinical Development, Hematologic Malignancies will serve as a Medical Monitor for post-marketing studies, focusing on the day-to-day medical oversight of complex combination and basket trials. Responsibilities include ensuring study integrity through rigorous eligibility reviews and real-time data interpretation.

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.
• 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.
• Serve 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.
• Participate in or lead clinical development contributions to due diligence or other business development activities.
• Contribute to partnership with Discovery colleagues to design and implement clinical translational strategies.
• Stay abreast of professional information and technology through conferences, medical literature, and training to augment expertise in the therapeutic area.
• Represent Menarini-Stemline at key external meetings.

Requirements

• 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.
• Excellent oral and written English communication skills, including presentation skills.
• Ability to exercise judgment and address complex problems, creating solutions for one or more projects.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team.
• Ability 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.

Pay

Base Salary Range of $289,000-$342,000.

Benefits

• 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.
• Pre-tax FSA/HSA programs.

About the Company

Founded in 1886 in Naples, Menarini is an Italian pharmaceutical company with nearly 135 years of history, headquartered in Florence. The Menarini Group operates in 70 countries, with products sold in 140 locations worldwide. Its workforce of around 18,000 employees produces over 500 million packs of drugs annually across 18 manufacturing sites, including a biotech plant for monoclonal antibodies.

Menarini has a strong commitment to oncology, with a pipeline of five investigational compounds for hematological and solid tumors. The acquisition of Stemline Therapeutics in 2020 strengthened its oncology portfolio, adding commercial and clinical-stage assets such as Tagraxofusp, a first-in-class targeted therapy for blastic plasmacytoid dendritic cell neoplasm (BPDCN). Menarini also holds rights to commercialize Selinexor in Europe, Latin America, and other regions, and Elacestrant for hormone receptor-positive advanced breast cancer.