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Medical Director, CRU
2 months ago
We are seeking a highly experienced and skilled Medical Director to join our team at ProSciento, Inc. As a key member of our leadership team, you will be responsible for overseeing the clinical aspects of our human trials and ensuring the safe, reliable, and successful conduct of clinical drug research.
Key Responsibilities- Evaluate Clinical Trials: Assess proposed clinical trials for scientific value, ethical considerations, and feasibility in conjunction with our clinical management team.
- Plan and Manage Clinical Resources: Assess and plan future clinical human resource and process needs, and manage and oversee clinical aspects of human trials at ProSciento.
- Lead Clinical Operations: Serve as Principal Investigator for clinical studies at ProSciento, oversee and manage other PI colleagues and clinical personnel, including Sub Investigators.
- Develop and Implement Policies: Develop and implement policies for interface between clients and clinical activities, and provide primary oversight of clinical resources.
- Supervise and Train Clinical Staff: Maintain and oversee training program for all clinical staff, and evaluate clinical training needs for ProSciento and for studies.
- Communicate with Sponsors: Maintain communications with sponsors during the conduct of the clinical trials.
- Medical Degree and Experience: Medical degree and/or equivalent, with 5 years related experience in a director or supervisory role.
- Regulatory Knowledge: Experience with current standards of Good Clinical Practice and familiarity in working with FDA, DEA, ICH, state, and other regulations relevant to the conduct of clinical drug research.
- Leadership Skills: Proven leadership skills, with ability to foster team building, positive communication, and corporate culture within the medical team.
- Certifications and Licenses: Current unrestricted license to practice medicine in the State of California, Advanced Cardiac Life Support (ACLS) certification, and Columbia-Suicide Severity Rating Scale (C-SSRS) training.
- Language Skills: Ability to read, analyze, and interpret complex documents, and create written documentation and/or articles assimilating scientific data into comprehensive formats.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
