Director, Clinical Scientist, Hematology

ResponsibilitiesResponsible for design and execution of assigned clinical study/activities and works closely with clinical team members to execute activities associated with study conduct.Develop studies in accordance with current Stemline Menarini policies and procedures.Possesses scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.Contributes/ leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholdersPerforms clinical/medical data review, including clinical safety monitoring and activities and procedures that ensure patient safetyProficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategiesPromotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/programCollaborate cross-functionally to develop Synopsis/Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.Ensures prompt, quality communications with sites regarding protocol clarification and procedural queriesAuthor/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)May lead or support trial level activities for one or more trials with the necessary supervision.Collaborate and liaise with external partners (e.g., KOLs).Seek out and enact best practices with instruction.Provide regular and timely updates to manager/management as requested.Conduct literature review.May prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publicationsDevelop site and CRA training materials and present these at SIVs and Investigator meetings.Review clinical narratives.Collaborate cross-functionally to monitor clinical data for specific trends.Contribute to the development of Data Review Plan in collaboration with Data Management.Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming and may participate in UAT.Submit clinical documents to TMF.Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.QualificationsBasic Life Science degree or equivalent and 10 years of industry or relevant experience with 5+ years as clinical scientistAdvanced degree (e.g. MS, PhD, PharmD) or equivalent experience, preferredHaematology oncology experience, requiredBasic to intermediate knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolutionIntermediate problem solving and critical thinking skills.Understanding of the pharmaceutical industry and the clinical development processClinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publicationAdaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)Knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.Good interpersonal relationship building/maintenance Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Menarini Stemline is an equal opportunity employer. We celebrate diversity and are 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.

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