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Sr. Manager/Associate Director, Global Collaborative Studies, Hematology

Stemline Therapeutics, Inc.

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At a glance

Compensation
No compensation found
Location
NEW YORK, NY
Work Authorization
Not specified

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Job overview

As a Senior Manager on the Global Medical Affairs team, this role manages a subset of externally sponsored research studies in the hematology portfolio through submission, feasibility assessment, contracting, execution, and results dissemination. It serves as the primary study contact for internal and external stakeholders, ensures research follows applicable procedures and regulations, and supports the Senior Director by overseeing delegated systems and processes.

Skills & qualifications

RequiredNice to have

Skills

Clinical Research ManagementHematology Oncology ResearchGlobal Study ManagementCFRICH GCPContracting StandardsGDPRData PrivacyIndependent WorkCross-Functional CollaborationCritical ThinkingPrioritizationInfluenceEnglish CommunicationPresentation SkillsDatabase SkillsCybergrantsMicrosoft Office

Qualifications

Bachelor's Degree or Equivalent5+ Years Relevant Experience

Full job description

Overview:As a Senior Manager working on the Global Medical Affairs team, you will be accountable for the management of a subset of the Menarinis haematology portfolio of high-impact externally sponsored research (ESR) studies through the full lifecycle of each projectfrom initial submission and feasibility assessment through contracting, execution, and results dissemination. ESR studies encompass independent (e.g. investigator-initiated studies/trials etc.) and collaborative interventional and non-interventional studies. As the primary point of contact for each study, this is a highly collaborative role, providing study, project, and program support to internal stakeholders, cross-functional departments, and external sponsor teams. This role is responsible for ensuring that ESR program adheres to all applicable SOPs, laws, regulations, and best practices in the execution of our research program. The Senior Manager supports the Senior Director by overseeing delegated systems and processes critical to the function of the ESR team. This role requires thorough understanding of the various aspects of externally sponsored research and ability to independently resolve arising challenges, judiciously escalating issues that require attention of leadership. Responsibilities: Personally drives execution of a subset of studies in the portfolio, including Managing startup (protocol review, contracting, financial set-up, document collection, drug supply set-up, and study activation), study execution, close-out, and dissemination of resultsMonitoring and managing individual study budgets Monitoring and tracking activities and key milestones on individual studies throughout their lifecycle, summarizing this information for any relevant reporting, cross-functional communication, and stakeholder awarenessDeveloping and maintaining relationships with external collaborators, including healthcare professionals, healthcare organizations, research organizations, site staff, and other supporting rolesEscalating issues proactively, recommending and implementing innovative processes to address and improve identified difficultiesLeads the operational management of the Menarini Medical Affairs Research Committee (MARC) and related governance meetings, including logistics, material preparation, minutes, and tracking of action itemsServes as the team's subject matter expert and lead for the Cybergrants portal. Qualifications: Bachelors degree or equivalent, preferably in life sciences or healthcare fieldMinimum of 5 years of relevant experience in academic clinical research setting and/or pharmaceutical/biotech industry, preferably in medical affairs research operationsExperience managing independent or collaborative research in Haematology/Oncology or a related fieldGlobal (e.g. US, EU, LATAM, APAC, etc.) experience in the planning, launching, maintenance and closure of interventional and non-interventional studies, including relevant knowledge of CFR, ICH GCP, contracting standards, and GDPR/data privacy requirementsProven ability to work independently in a virtual, cross-functional, and geographically diverse environment.Demonstrated resourcefulness and critical thinking skills, with a solution-oriented mindset and effective use of available tools and data.Skilled in prioritizing competing demands, managing urgent and high-impact tasks, and escalating appropriately to leadership and key stakeholders.Effective at building influence across functional boundaries and navigating complex, evolving matrixed organizationsMust possess excellent oral and written English communication skills, including presentation skillsBasic technical and electronic skills, such as databases [e.g.: cybergrant], systems, and Microsoft Office computer programs Please note: This position is classified as a corporate office position. In accordance with the New York state employer convenience rule, Stemline will withhold New York state income taxes for all

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