Thermo Fisher Scientific

Medical Director – Clinical Trial Physician, Rheumatology

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: North Carolina • United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Provides clear medical leadership in the Study team
  • working in close collaboration with the other members of this cross functional team
  • Provide medical leadership to the study teams, including creating clinical trial protocols
  • 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
  • ensure medical validity of each individual primary endpoint as well study subject safety
  • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
  • Collaborate with the cross functional study team members

Requirements

  • Medical Doctor or equivalent degree required
  • Board certification(s) are preferred
  • Specialty education(e.g. residency/fellowship) required in rheumatology
  • This should be accompanied by patient treatment and/or research experience
  • 1-3 years of industry experience preferred
  • Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization
  • Excellent English, both written and spoken is a must
  • Shown understanding and experience with NDA submission process
  • Shown understanding of regulatory guidelines for adverse event reporting
  • Proven interpersonal skills enabling to lead a study team
  • Pro-active problem solver with negotiation skills
  • Strong communication skills
Benefits
  • competitive remuneration
  • annual incentive plan bonus
  • healthcare
  • range of employee benefits
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial protocolssite selectionClinical Study Reports (CSRs)Informed Consent Forms (ICFs)Case Report Forms (CRFs)protocol deviation decisionsprimary endpoint validationstudy complianceSOPsGCP
Soft Skills
medical leadershipcollaborationinterpersonal skillsproblem solvingnegotiation skillscommunication skills
Certifications
Medical DoctorBoard certificationspecialty education