Thermo Fisher Scientific

Associate Medical Director, Pulmonology

Thermo Fisher Scientific

full-time

Posted on:

Origin:  • 🇮🇹 Italy

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Job Level

Lead

Tech Stack

Google Cloud PlatformUnity

About the role

  • Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information
  • Contribute to site selection; 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
  • Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint and study subject safety; identify medical issues early
  • Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
  • Serve as chief liaison between sponsor and all PPD internal departments during all study phases
  • Educate investigator sites by delivering protocol specific lab procedures presentation and demonstration during investigator meetings
  • Medical point of contact for all internal and external stakeholders: interact with investigators, answer questions of IRBs and Health Authorities, prepare and present material to study executive and independent safety committee; medical training of site staff and CRA training in new indications
  • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
  • Closely collaborate with cross functional study team members to communicate medical risks, issues, and results

Requirements

  • MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Pulmonology patients in hospital practice
  • Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
  • Is fluent in spoken and written English
  • Shown understanding and experience with NDA submission process
  • Shown understanding of regulatory guidelines for adverse event reporting
  • Strong communication & presentation skills and is a strong teammate
  • Knowledge of relevant SOPs and GCP