Clinical Research Director
4 days ago
Job Summary:
We are seeking a highly skilled Clinical Research Director to oversee the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program. The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to work effectively in a team environment.
Key Responsibilities:
* Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program
* Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy
* Manages design & implementation of study protocols for clinical development program in support of the overall Product Development Plan, based on medical & scientific principles, knowledge of compliance & regulatory requirements, customers, markets, business operations, & emerging issues
* Oversees project-related education of investigators, study site personnel, & study staff
* Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
* Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables
* Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
Requirements:
* Medical Doctor (M.D. degree with relevant therapeutic specialty in an academic or hospital environment
* Ability to run a clinical research study with appropriate supervision
* Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred
* Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable
* Ability to interact externally and internally to support global scientific and business strategy
* Must possess excellent oral and written English communication skills
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