Medical Director, Clinical Development, Hematologic Malignancies

Medical Director, Clinical Development, Hematologic Malignancies

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.

Responsibilities include:

• 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 include:

• 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.