Director, Clinical Scientist – Hematology Oncology

Menarini Group; New York (NY); In loco; USD 218.000 - 255.000; Tempo pieno

Descrizione del lavoro

Menarini Stemline is seeking a Director, Clinical Scientist to provide scientific leadership in designing and executing hematology oncology clinical studies. The role leads cross-functional teams, reviews safety data, and collaborates with external partners to advance a development program.

Domestic and international travel may be required. The position demands a strong clinical development background, advanced degree, and extensive experience in early to late-stage assets, with oversight of

Competenze

• Basic Life Science degree or equivalent and 10 years of industry or relevant experience with 5+ years as clinical scientist
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience, preferred
• Haematology oncology experience, required
• Understanding of the pharmaceutical industry and the clinical development process
• Clinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publication
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools

Mansioni

• Responsible 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 stakeholders
• Performs clinical/medical data review, including clinical safety monitoring and activities and procedures that ensure patient safety
• Promotes 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/program
• Collaborate 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 queries
• Author/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 publications
• Develop 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.

Conoscenze

Haematology oncology experience

Interpersonal skills

Data review tools

MS Word/Excel/PowerPoint

Regulatory knowledge

Clinical data review

Formazione

Basic Life Science degree

Advanced degree (MS/PhD/PharmD)

Strumenti

Data review tools

Descrizione del lavoro

Menarini Stemline is seeking a Director, Clinical Scientist to provide scientific leadership in designing and executing hematology oncology clinical studies. The role leads cross-functional teams, reviews safety data, and collaborates with external partners to advance a development program.

Domestic and international travel may be required. The position demands a strong clinical development background, advanced degree, and extensive experience in early to late-stage assets, with oversight of