Medical Director, CRU

4 weeks ago

Chula Vista, California, United States ProSciento, Inc Full time
Job Summary

ProSciento, Inc is seeking a highly skilled Medical Director, CRU to lead our clinical research efforts. The successful candidate will be responsible for ensuring the safe, reliable, and successful conduct of clinical drug research through the direction and coordination of activities and functions of the medical department.

Key Responsibilities
  • Evaluate proposed clinical trials for scientific value, ethical considerations, and feasibility in conjunction with the clinical management team.
  • Assess and plan future clinical human resource and process needs.
  • Manage and oversee clinical aspects of human trials at ProSciento.
  • Serve as Principal Investigator for clinical studies at ProSciento and oversee and manage other PI colleagues and clinical personnel including Sub Investigators.
  • Support protocol development, study report development, and preparation as needed.
  • Interface with pharmacy staff on study needs and conduct.
  • Act as liaison between clinical operations and project management.
  • Evaluate clinical training needs for ProSciento and for studies.
  • Develop appropriate clinical training curriculum in conjunction with quality assurance and clinical operation departments.
  • Maintain and oversee training program for all clinical staff.
  • Maintain communications with sponsors during the conduct of the clinical trials.
  • Develop and implement policies for interface between clients and clinical activities.
  • Provide primary oversight of clinical resources, determining physician and clinical resource needs and utilization within the clinic.
  • Supervise the conduct of clinical trials for accuracy and efficacy in accordance to the highest clinical research standards (GCP/ICH) standards, clinical standards, and to all applicable FDA regulations.
  • Provide leadership, foster team building, positive communication, and corporate culture within the medical team.
  • Responsibility for employee health assessments.
  • Participate in business development and client liaison activities.
Requirements
  • Medical degree and/or equivalent.
  • 5 years related experience in a director or supervisory role.
  • Experience with technical, clinical, regulatory, and managerial aspects of clinical drug research and as a principal/sub-investigator with various drug studies.
  • 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.
Preferred Qualifications
  • Current unrestricted license to practice medicine in the State of California.
  • Advanced Cardiac Life Support (ACLS) certification.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) training is required and will be provided by the company.
  • GCP training is required and will be provided by the company.
What We Offer

ProSciento, Inc offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

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