Medical Director, Clinical Development Hematology

Stemline Therapeutics, Inc. • New York, NY • 1h ago

Company:0750 Stemline Therapeutics IncContract Type:PermanentJoin us in shaping the future of Menarini - with passion, integrity, and a deep commitment to people. About Menarini Group - Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. For more than 135 years, we have worked to improve patients lives across a broad range of therapeutic areas through our dedication to science, integrity, and care for people. With a strong foundation in scientific excellence and a purpose-driven culture, Menarini offers diverse career opportunities for professionals eager to make a meaningful impact on global health. Position Title: Medical Director, Clinical Development, Hematology Reports To: Vice President, Global Clinical Sciences, Hematology Overview: The Medical Director, Clinical Development, Hematology will lead the clinical direction, planning, execution, and interpretation of clinical trials of one or more Heme-oncology clinical development programs, in close collaboration with the Alliance partner. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. The (Senior) Clinical Development Director will be focused primarily on Clinical development of the Menarini-Stemline Hematology Portfolio. Responsibilities: Participates or leads and demonstrates ownership of the design and implementation of multiple clinical development protocols within the hematology clinical program of an asset in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Menarini-Stemlines customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Menarini-Stemline study staff.Has the overall responsibility for monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols for which they are responsible.Responsible, in collaboration with the clinical scientist, for analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.May oversee the work of Medical and/or Scientific Directors and or Clinical Scientists working on the same or related programs.May serve on or lead Clinical Strategy Teams, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.In the role of CST Lead, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development teams.May 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.May acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Oncology Development, Regulatory, Medical Affairs, Commercial and other functions in

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