Menu +

Medical Director

Job Description:

The Medical Director will ensure the medical and scientific integrity of clinical trials conducted by Company in an assigned therapeutic area.


Responsibilities:

  • Develop Clinical Development Plan (CDP) and act as the clinical lead for protocols and supportive activities to meet the CDP objectives
  • Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
  • Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
  • Design, develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III
  • Oversee and manage the development process for protocols
  • Participate in the design for investigator brochures and case report forms
  • Interact with principal investigators and opinion leaders to facilitate clinical trials research
  • Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
  • Establish and review protocols, investigator brochures, study reports and other documents
  • Play a key role in the delivery of high quality clinical data
  • Serve as liaison to the commercial team on medical issues
  • Acts to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
  • Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
  • Participate in clinical study report conceptualization, development and writing for global regulatory submissions
  • Prepare and monitor budgets
  • Provide effective management of human resources – recruitment, performance management, succession planning, talent management, etc.


Requirements:

  • MD, board certified preferred in oncology
  • Requires at least 5 years’ clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution
  • Relevant clinical research experience in academic settings will be reviewed in light of clinical development experience


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesAbility to handle multiple projects simultaneously in a fast-paced environment


If you are interested, please submit your resume by email to careers@corcept.com

built@zoomedia
You are now leaving this website. If you would like to continue, click Continue.
Cancel Continue