Medical Director – Clinical Trial Physician, Pediatrics
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Provides clear medical leadership in the Study team
- 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
- 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
- Medical point of contact for all internal and external stakeholders
- 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
Requirements
- Medical Doctor or equivalent degree required
- Board certification(s) are preferred
- Specialty education(e.g. residency/fellowship) required in pediatrics
- 1-3 years of industry experience required
- Experience should be in clinical development or medical monitoring in a Pharmaceutical, Biotech or CRO organization
- Pediatricians with expertise in Pediatric Neurology, Rheumatology or Rare Disease are highly preferred.
- Excellent English, both written and spoken is a must, as well as ability to travel
- 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, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgment in which issues need to be escalated immediately
- Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization
- Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties.
- A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and actions.
Benefits
- We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial protocolsmedical monitoringclinical study reportsinformed consent formscase report formsregulatory documentsNDA submission processadverse event reportingpediatric neurologyrheumatology
Soft skills
interpersonal skillsleadershipproblem solvingnegotiation skillscommunication skillscollaborationjudgmentcultural sensitivitytransparencydecision making
Certifications
Medical DoctorBoard certificationspecialty education