Director, Clinical Scientist, Hematology

MENARINI Group•New York, NY

21h•$218,000 - $255,000

About The Position

The Director, Clinical Scientist provides scientific expertise and leadership to design and deliver clinical studies in support of new product development and marketed products. The role contributes to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data for a clinical development program. The Director may participate in or lead work in a matrix environment as part of a cross-functional team and may contribute to candidate development projects across early- and late-phase development. This position is part of the Hematological Malignancies Clinical Development department and collaborates closely with Medical Directors in Clinical Development. It may serve as lead Clinical Scientist for assigned protocols or as a delegate of the Therapeutic Area Lead Clinical Scientist. The role may contribute to or lead protocol and program team meetings, scientific advisory boards, study steering committees, and data and safety monitoring meetings, represent the function in cross-departmental activities, and serve as a member of the Clinical Study Team. The position is classified as a corporate office position. Domestic and international travel may be required, approximately 10–20%.

Requirements

Basic life science degree or equivalent and 10 years of industry or relevant experience, including at least 5 years as a clinical scientist.
Hematology oncology experience.
Basic to intermediate knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and evolving treatment guidelines.
Intermediate problem-solving and critical-thinking skills.
Understanding of the pharmaceutical industry and clinical development process.
Clinical training and/or applicable clinical research experience, with understanding of running a clinical trial from concept and study idea through publication.
Adaptability and flexibility to manage multiple demands and shifting priorities and meet day-to-day challenges with confidence and professionalism.
Intermediate skills in Microsoft Word, Excel, and PowerPoint, and data review tools such as patient profiles and report-generating tools.
Knowledge of worldwide regulatory and safety requirements relevant to drug development, research projects, and/or market support.
Good interpersonal relationship-building and maintenance skills.

Nice To Haves

Advanced degree (e.g., MS, PhD, or PharmD) or equivalent experience.

Responsibilities

Design and execute assigned clinical studies and activities, working closely with clinical team members on study conduct.
Develop studies in accordance with current Stemline Menarini policies and procedures.
Propose, design, and execute clinical research and development studies for early- and/or late-stage assets, and communicate strategy proposals grounded in supporting literature.
Contribute to or lead planning and prepare information for external and stakeholder meetings, including investigator meetings, governance meetings, data monitoring committees, and regulatory authority meetings; present data to external investigators and internal stakeholders.
Perform clinical and medical data review, including clinical safety monitoring and activities and procedures that ensure patient safety.
Understand how program objectives and design affect data analysis, identify risks, and design mitigation strategies.
Promote consistent first-line medical and clinical data review techniques across studies and programs; review clinical data review plans and author medical monitoring plans for assigned studies or programs.
Collaborate cross-functionally to develop synopsis, protocol, and informed consent documents and amendments, and present them to governance committees and early clinical development team meetings as required.
Ensure prompt, high-quality communications with sites regarding protocol clarification and procedural queries.
Author or review clinical contributions to clinical study reports and clinical sections of regulatory documents, including Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, and responses to health authorities, ethics committees, and institutional review boards; contribute to regulatory submissions.
Lead or support trial-level activities for one or more trials with appropriate supervision.
Collaborate and liaise with external partners, including key opinion leaders.
Seek out and implement best practices with instruction, and provide regular, timely updates to management as requested.
Conduct literature reviews.
Prepare and present data externally through abstracts, posters, symposium and conference presentations, and journal publications, as applicable.
Develop site and CRA training materials and present them at site initiation visits and investigator meetings.
Review clinical narratives.
Collaborate cross-functionally to monitor clinical data for specific trends.
Contribute to data review plan development with Data Management.
Ensure CRF design supports protocol-aligned data collection in collaboration with Data Management and Programming, and may participate in user acceptance testing.
Submit clinical documents to the trial master file.
Ensure prompt, high-quality responses to institutional review boards, ethics review committees, independent data monitoring committees, and similar bodies.