Regeneron
Manager,ClinicalScientist,Hematology
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“Manager, Clinical Scientist, Hematology at Regeneron. Skills: Clinical study design, Clinical data interpretation, Hematology. Lead development of clinical studies. Evaluate clinical studies”
Industry & Context.
Resolves novel problems
4 days per week on site
What They're Looking For.
Must Have
Bachelor's Degree, 3 years pharmaceutical clinical drug development experience, Basic knowledge of oncology or hematology, Proven leadership in global clinical trials, Proficient knowledge of clinical development process, Proficient knowledge of regulatory requirements, Proficient knowledge of ICH/GCP guidelines
Nice to Have
Advanced degree in life science/healthcare preferred, Proven track in clinical trial process improvements
What You'll Do.
Lead development of clinical studies
Evaluate clinical studies
Plan clinical studies
Execute clinical studies
Ensure scientific integrity of study data
Contribute to candidate development projects
Collaborate with Medical Director
Provide scientific expertise
Design clinical studies
Deliver on clinical studies
Contribute to program team meetings
Represent function in collaborative activities
Develop understanding of therapeutic disease area
Develop understanding of drug candidate
Apply scientific expertise to studies
Support initiation of clinical research
Support execution of clinical research
Assist with development of Expanded Synopsis
Author clinically relevant sections
Review scientific portions of protocols
Assist with documents related to trials
Author documents related to trials
Review documents related to trials
Maintain compliance with guidelines
Contribute to preparations for meetings
Present data to external investigators
Present data to internal collaborators
How You'll Work.
Team & Collaboration
Clinical Study Team; Global Clinical sub-team; Cross-functional team; Collaborative activities
Communication Scope
Clear messages; Presentation skills
Process & Methodology
Clinical program execution
Full Job Description
**Build our future together:** At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Clinical Scientist, Hematology department. You will lead in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads 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. The Manager reports to either Senior Manager, Associate Director or Director, Clinical Sciences and collaborates closely with Medical Director (MD) to provide scientific expertise necessary to design and deliver on clinical studies and programs. **When & where:** * Location: Tarrytown, NY, Warren, NJ * Hybrid; 4 days per week on site **Discover your role:** * Member of the Clinical Study Team and Global Clinical sub-team; Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments * Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape * Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets * Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments * Assists with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support development of
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