Clinical Research Medical Director (Phase 1)

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt;">Labcorp Drug Development is seeking a <strong>Clinical Research Medical Director (PHASE 1)</strong> 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;</span></p><p style="margin: 0px;"> </p><ul><li style="margin-left: .25in;"><span style="font-size: 12pt;">Act as Principal Investigator/Co-Investigator.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Represents Clinical Pharmacology as the medical expert for early clinical trials.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Acts as consultant with regard to scientific/medical study design.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Evaluate the performance of the medical staff.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Ensure medical coverage for clinical studies.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Establish and maintain close affiliations with the medical community.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Review and evaluate protocols and Investigator Brochures, and provide clinical and scientific support as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Discuss medical design aspects with the monitor/sponsor as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Attend study initiation meetings as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Present protocols at IRB/IEC meetings, as required.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Review relevant data for dose escalation.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Administer test article to the subject, or delegate this to nursing staff where appropriate.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Inform Principal Investigator, IRB and Sponsor as appropriate of relevant events.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Review and sign CRFs at the conclusion of the study.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Sign notes of administrative change and Notes to Study File.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Meet with Monitor at monitor visits</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Review and sign study clinical reports.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Delegate the above as appropriate.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Serves as a member of the Senior Management Group.</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12pt;">MD Degree with postgraduate clinical training</span></li><li><span style="font-size: 12pt; font-family: verdana, geneva;">Relevant sub-specialty fellowship training preferred</span></li><li><span style="font-size: 12pt; font-family: verdana, geneva;">Board Certification history preferred</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 12pt;">5 - 10 years experience in conducting clinical research.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">At least 10 years of progressive and proven leadership responsibilities in a related business environment.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Leadership Competency Level: Business Functional Leader</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt;">Skilled in external client interactions and delivering presentations</span></li></ul>