Director, Clinical Scientist, Hematology

Overview

The Director Clinical Scientist role provides scientific expertise necessary to design and deliver clinical studies. This role will provide clinical expertise and leadership in support of new product development and marketed products for the team.

We are seeking a Director to join our Hematological Malignancies Clinical Development department. The Director, Clinical Scientist will contribute to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director may participate in and/or lead in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development.

Director reports to the VP, Global Clinical Sciences and collaborates closely with Medical Directors in Clinical Development to provide scientific expertise necessary to design and deliver on clinical studies and/or programs.

As a Clinical Scientist Director, a typical day may include the following:

Functioning as lead Clinical Scientist for assigned protocol(s) and/or may function as delegate of Therapeutic area Lead Clinical Scientist. May contribute or lead protocol/program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments;
Member of the Clinical Study Team.

Domestic and international travel may be required (approximately 10-20%)

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• 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
• Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis;
  Identifies risks and designs mitigation strategies
• 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.

• 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
• Basic to intermediate knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
• Intermediate problem solving and critical thinking skills.
• Understanding of the pharmaceutical industry and the clinical development process
• Clinical training and/or…