Clinical Research Medical Director (Phase 1)
Labcorp Drug Development is seeking a Clinical Research Medical Director (PHASE 1) to join our Clinical Pharmacology team based in Dallas TX. Reporting to the Vice President, Clinical Pharmacology, the incumbent will be responsible for providing medical direction for the conduct of early clinical trials. Additionally, the Medical Director will be responsible for supporting the development activities of proposed and ongoing projects in their area of expertise, as well as medical monitoring for assigned clinical studies. Key responsibilities and duties to include;
- Act as Principal Investigator/Co-Investigator.
- Represents Clinical Pharmacology as the medical expert for early clinical trials.
- Acts as consultant with regard to scientific/medical study design.
- Evaluate the performance of the medical staff.
- Ensure medical coverage for clinical studies.
- Establish and maintain close affiliations with the medical community.
- Review and evaluate protocols and Investigator Brochures, and provide clinical and scientific support as needed.
- Discuss medical design aspects with the monitor/sponsor as needed.
- Attend study initiation meetings as needed.
- Present protocols at IRB/IEC meetings, as required.
- Perform pre-study physical examinations and review vital signs, medical histories, ECGs, and lab data to ensure volunteers are medically and mentally fit upon entering the study.
- Perform on-study and post-study physical examinations and review adverse events, vital signs, ECGs, and lab data to ensure that the physical and mental well being of volunteers is undiminished at the end of the study.
- Review relevant data for dose escalation.
- Administer test article to the subject, or delegate this to nursing staff where appropriate.
- Inform Principal Investigator, IRB and Sponsor as appropriate of relevant events.
- Review and sign CRFs at the conclusion of the study.
- Sign notes of administrative change and Notes to Study File.
- Meet with Monitor at monitor visits
- Review and sign study clinical reports.
- Delegate the above as appropriate.
- Serves as a member of the Senior Management Group.
- MD Degree with postgraduate clinical training
- Relevant sub-specialty fellowship training preferred
- Board Certification history preferred
- 5 - 10 years experience in conducting clinical research.
- At least 10 years of progressive and proven leadership responsibilities in a related business environment.
- Leadership Competency Level: Business Functional Leader
- Skilled in external client interactions and delivering presentations
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