Clinical Research Nephrology Medical Director

Kelly Science & Clinical is seeking a Nephrology Medical Director for a fulltime, contract position with a large CRO client. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.Remote Position: Central or East time zone preferred Fulltime: 40 hours/weekContract: Long term opportunity, at least 2 years with potential to convert or continue as contractDue to continued growth, our client is now looking to appoint a Medical Director in Nephrologist, to join their team . This role can be office-based or home based.The Clinical Research Medical Director will be responsible for providing clinical study development and medical support for clinical trials and safety evaluation within the Pharmacovigilance department.Essential Functions:Provide medical leadership to the study teams , including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection , contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trialsReal time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction of issues in consultation with the Global Medical Indication LeadInterpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication LeadMedical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indicationsEnsure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCPClosely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties Education & QualificationsMD/DOStrong medical knowledge, proven clinical experience managing Nephrology patients in hospital practiceMust be Board Eligible or Board Certified in NephrologySignificant experience within pharmaceutical industry as a Medical Director for sponsor or CRO clinical studies Is fluent in spoken and written EnglishSolid understanding of regulatory guidelines for adverse event reportingStrong communication & presentation skills and is a strong team player 9375910 Morrisville, NC, US Scientific Doctorate/PhD Full Time, Temporary Manager (Manager/Supervisor) Remote Biotechnology/Pharmaceuticals First Shift (Day)