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Medical Director – Neurology
Thermo Fisher Scientific. Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Neurology with a strong foundation in clinical trial oversight, regulatory compliance, and safety monitoring. Proficient in medical consultation, data analysis, and effective communication with stakeholders in clinical research settings.
Highest-signal resume keywords
MD Or EquivalentClinical Experience In NeurologyClinical Trial ExperienceUnderstanding Of FDA, ICH, EMA, And GCP GuidelinesWorking Knowledge Of MedDRA
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical OversightSafety MonitoringAdverse Event ReviewData Review And ValidationTherapeutic Expertise In NeurologyClinical DevelopmentPharmacovigilanceBiostatisticsClinical Operations ProceduresProtocol Training
Soft Skills
Decision-MakingProblem-SolvingOrganizational SkillsAnalytical SkillsInterpersonal SkillsInfluencing SkillsTeam-Building SkillsAttention To DetailAbility To Work IndependentlyFlexibility
Tools & Technologies
Safety DatabasesComputer ApplicationsIn-House SoftwareOff-The-Shelf Software
Certifications & Qualifications
Active Medical Licensure
Industry Keywords
Good Clinical PracticeClinical TrialsContract Research OrganizationSerious Adverse EventsRegulatory RequirementsICH GuidelinesClient SOPsPatient Treatment ExperienceNeuromuscular ExperienceComprehensive Background Check
About the role
Key responsibilities & impact- Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
- Attend and present at investigator and sponsor meetings
- Provide medical consultation to clients, investigators, project team members, and associates
- Support business development activities
- Provide medical review and analysis for clinical trial serious adverse events
- Ensure tasks delegated to medical monitors are properly executed
- Adhere to applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies
- Answer study-related medical questions and maintain clear communication with associates and clients
- Provide therapeutic and protocol training on assigned studies
- Assist in writing and/or review of CSR, IND/NDA, ICSR, signal detection, periodic, RMP, REMS, and CTD reports/modules
- Monitor safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and unblinding requests
- Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical situations
- Review adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites
- Perform contractually specified data review and validation, including coding listings and/or full safety data, to assess potential safety concerns
Requirements
What you’ll need- MD or equivalent required
- Candidates should have clinical experience in Neurology and formal training in Neurology (i.e residency and/or fellowship)
- Patient treatment experience comparable to 2 years
- For Senior Medical Director: suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator comparable to 1–2 years; or direct experience in safety/Pharmacovigilance comparable to 2 years
- Preference toward clinical development/medical monitoring experience
- Active medical licensure preferred but not required
- Neuromuscular experience and/or specialization preferred but not required
- Must be legally authorized to work in the United States or Canada without sponsorship
- Must be able to pass a comprehensive background check, including drug screening where applicable
- Therapeutic expertise in Neurology
- Strong decision-making, problem-solving, organizational, and analytical skills
- Excellent oral and written communication skills
- Working knowledge of relevant safety databases, e.g. MedDRA
- Flexibility to travel domestically and internationally
- Ability to work independently, analyze work with attention to detail, and prioritize sensitive complex information
- Proficiency in basic computer applications
- Fluent in spoken and written English
- Excellent interpersonal, influencing, and team-building skills
- Understanding of FDA, ICH, EMA, and GCP guidelines
- Working knowledge of biostatistics, data management, and clinical operations procedures
- Ability to mentor/train other staff
- Ability to access and use in-house and off-the-shelf computer software
- Regular and consistent attendance
- Ability to perform under stress and multitask
Benefits
Comp & perks- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Employee benefits
- Career and development prospects
- Innovative, forward-thinking organization
- Exciting company culture centered on integrity, intensity, involvement, and innovation