| Medical Director at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=670600&uid= From: Rubel Khan, Tek Inspirations [email protected] Reply to: [email protected] Title: Medical Director Location: Remote Visa : USC MOI : Skype Must have skill for Medical Director/Clinical Trial Physician with Immunology or Neurology or Nephrology: Current/recent experience in Biotech/Pharma companies Be Board Certified or eligible to be Board Certified Board certified physician Feedback on rejected candidates: Does not have relevant field (i.e. immunology, rheumatology) Lack of subspecialty training in immunology or related field (i.e. rheum, derm) No pharma industry experience Clinical development experience is too limited with very small biotechs companies Education & Qualifications: MD or equivalent degree and strong medical knowledge, proven clinical experience managing Neurology patients in hospital practice Significant experience within pharmaceutical industry, clinical trials or pharmaceutical medicine is beneficial Is fluent in spoken and written English Solid understanding of regulatory guidelines for adverse event reporting Strong communication & presentation skills and is a strong team player At PPD as part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development program, ensuring you reach your potential. 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 trials Real 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 Lead Interpret 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 Lead Medical 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 indications Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties Keywords: Maryland http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=670600&uid= |
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| 09:07 AM 22-Sep-23 |