What are the responsibilities and job description for the Senior Director of Clinical Research position at Jobleads-US?
Company Overview
Regeneron is a leading biotechnology company dedicated to harnessing the power of biology to bring innovative treatments to patients. Our commitment to innovation, collaboration, and excellence has enabled us to develop life-changing medicines that improve the lives of millions of people worldwide.
Job Summary
The Associate Director Clinical Scientist plays a critical role in the development, evaluation, planning, and execution of clinical studies. This position requires a strong scientific background, excellent leadership skills, and the ability to work effectively in a matrix environment. The successful candidate will lead cross-functional teams, contribute to program team meetings, and maintain a proficient understanding of therapeutic disease areas and drug candidates.
Key Responsibilities
* Develop and execute clinical study plans, including study design, protocol development, and data management* Collaborate with internal stakeholders to ensure scientific integrity and interpretation of study data* Contribute to program team meetings, scientific advisory boards, and data/safety monitoring meetings* Maintain a proficient understanding of therapeutic disease areas and drug candidates, including underlying disease biology, clinical manifestations, and therapeutic standard practice* Propose, design, and complete clinical research and development studies for early and/or late-stage assets* Author and/or review documents related to trials, such as medical monitoring plans, SAPs, informed consents, and clinical components of Clinical Study Reports* Perform quality review and/or approval of clinical trial documentation* Present data and information to external investigators and internal collaborators
Required Skills and Qualifications
* Bachelor's Degree or Advanced degree in life science/healthcare (PhD/MD/PharmD/MSc)* 10 years of pharmaceutical clinical drug development experience* Strong cross-functional management, interpersonal, and problem-solving skills* Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and medical writing skills* Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines*
Regeneron is a leading biotechnology company dedicated to harnessing the power of biology to bring innovative treatments to patients. Our commitment to innovation, collaboration, and excellence has enabled us to develop life-changing medicines that improve the lives of millions of people worldwide.
Job Summary
The Associate Director Clinical Scientist plays a critical role in the development, evaluation, planning, and execution of clinical studies. This position requires a strong scientific background, excellent leadership skills, and the ability to work effectively in a matrix environment. The successful candidate will lead cross-functional teams, contribute to program team meetings, and maintain a proficient understanding of therapeutic disease areas and drug candidates.
Key Responsibilities
* Develop and execute clinical study plans, including study design, protocol development, and data management* Collaborate with internal stakeholders to ensure scientific integrity and interpretation of study data* Contribute to program team meetings, scientific advisory boards, and data/safety monitoring meetings* Maintain a proficient understanding of therapeutic disease areas and drug candidates, including underlying disease biology, clinical manifestations, and therapeutic standard practice* Propose, design, and complete clinical research and development studies for early and/or late-stage assets* Author and/or review documents related to trials, such as medical monitoring plans, SAPs, informed consents, and clinical components of Clinical Study Reports* Perform quality review and/or approval of clinical trial documentation* Present data and information to external investigators and internal collaborators
Required Skills and Qualifications
* Bachelor's Degree or Advanced degree in life science/healthcare (PhD/MD/PharmD/MSc)* 10 years of pharmaceutical clinical drug development experience* Strong cross-functional management, interpersonal, and problem-solving skills* Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and medical writing skills* Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines*
