Regeneron Pharmaceuticals, Inc
Manager, Clinical Scientist, Hematology
Regeneron Pharmaceuticals, Inc, Baltimore, Maryland, United States,
The Manager, Clinical Sciences, Hematology leads in the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager 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 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.
As a Manager, a typical day may include the following: 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 author/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
This role may be for you if: Possess demonstrated knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrate solid medical writing skills 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 Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways
To be considered for this position, you must have a minimum of Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking ≥ a minimum of 3 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements. We need an individual with demonstrated 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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As a Manager, a typical day may include the following: 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 author/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
This role may be for you if: Possess demonstrated knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrate solid medical writing skills 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 Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways
To be considered for this position, you must have a minimum of Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking ≥ a minimum of 3 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements. We need an individual with demonstrated 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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