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Senior Medical Director, Trial Physician – Neurology
Thermo Fisher Scientific. Provide clear medical leadership to study teams and ensure reliable, high-quality study data within time and budget .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial protocol development, medical monitoring, and regulatory compliance, with a strong focus on neuromuscular disease and patient safety. Proven ability to lead cross-functional teams and communicate effectively with stakeholders in a dynamic clinical research environment.
Highest-signal resume keywords
Medical Doctor DegreeClinical Trial Protocol DevelopmentNeuromuscular Disease ExpertiseRegulatory Guidelines UnderstandingPatient Treatment Experience
ATS Keywords
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Hard Skills
Clinical Trial ProtocolsMedical MonitoringData InterpretationAdverse Event ReportingSOPs and GCP ComplianceNDA Submission ProcessStudy Protocol ReviewClinical Document PreparationStudy Data AnalysisMedical Training
Soft Skills
Interpersonal SkillsProactive Problem-SolvingNegotiation SkillsStrong CommunicationCollaboration Skills
Tools & Technologies
In-House SoftwareCommercial Software
Certifications & Qualifications
Board Certification Preferred
Industry Keywords
Clinical DevelopmentPharmaceuticalBiotechCROAutoimmune Disease TreatmentsClinical ResearchInvestigational Review Board (IRB)Health Authority InteractionStudy Executive CommitteesCross-Functional Collaboration
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide clear medical leadership to study teams and ensure reliable, high-quality study data within time and budget
- Create clinical trial protocols using the latest scientific information
- Contribute to site selection and review and approval of study protocols, amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
- Conduct real-time medical monitoring of clinical studies
- Ensure medical validity of primary endpoints and study-subject safety
- Identify, escalate, and correct medical issues in consultation with the Global Medical Indication Lead
- Interpret clinical trial data for regulatory documents, manuscripts, and other publications
- Serve as the medical point of contact for internal and external stakeholders
- Interact with investigators and answer IRB and Health Authority questions
- Prepare and present materials to study executive and independent safety committees when applicable
- Provide medical training to site staff at investigator meetings and CRA training for new indications
- Ensure medical compliance by understanding and applying relevant SOPs and GCP
- Collaborate with cross-functional study team members to clarify medical risks, issues, and results
- Work with a global, client-dedicated biotech organization developing autoimmune disease treatments
- Travel occasionally to domestic and international site locations
Requirements
What you’ll need- Medical Doctor or equivalent degree required
- Board certification(s) preferred
- Specialty education, such as residency/fellowship, required in neurology
- Patient treatment and/or research experience
- 1–3 years of industry experience required in clinical development within a Pharmaceutical, Biotech, or CRO organization
- Neuromuscular disease expertise highly preferred
- Excellent written and spoken English
- Ability to travel
- Understanding and experience with NDA submission process
- Understanding of regulatory guidelines for adverse event reporting
- Interpersonal skills to lead a study team and exercise judgment on issues requiring immediate escalation
- Proactive problem-solving and negotiation skills
- Strong communication and collaboration skills in a cross-functional, matrixed organization
- Must be legally authorized to work in North America without sponsorship
- Must be able to pass a comprehensive background check, including drug screening where applicable
- Must be located in the EST time zone
- Ability to access and use in-house and commercial computer software
- Regular and consistent attendance
- Ability to work independently, multitask, perform under stress, and sustain intense concentration
- Ability to perform the stated physical activities, including occasional lifting and carrying of 15–20 lbs.
Benefits
Comp & perks- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
- Career and development prospects
- Fully remote work arrangement
- 10–20% travel range, including possible international travel