Manager, Clinical Scientist, Hematology
Regeneron
Clinical Scientist, Hematology Manager
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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.
Location: Tarrytown, NY, Warren, NJ
Hybrid; 4 days per week on site
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 regulatory documents; may perform quality review
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Contributes to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority). Presents data and information to external investigators (SIV) and internal collaborators
Proven ability to influence within team and may influence across functionally
Exhibit strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills
This role requires:
Bachelor's Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
? A minimum of 3 years of pharmaceutical clinical drug development experience
You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements
Proven leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Resolves novel problems requiring creative application of advanced skill, training, and education
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