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Worldwide Clinical Trials

Senior Medical Director, Medical Affairs

Worldwide Clinical Trials

. Medically manage assigned clinical trials as Medical Monitor .

Posted 10/16/2026full-timeRemote • North Carolina • United StatesSenior💰 $175,000 - $348,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in medical monitoring and clinical trial management, with a strong focus on regulatory compliance, therapeutic knowledge, and effective communication. Proven ability to mentor medical staff and contribute to business development efforts through proposal generation and client interactions.

Highest-signal resume keywords
Medical Degree6-8 Years In CRO, Pharma, Or Biotech IndustryMedical MonitoringGCP KnowledgeSAE-Related Medical Review

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills
Medical MonitoringClinical Trial ManagementTherapeutic KnowledgeProposal GenerationSAE-Related Medical ReviewRegulatory ComplianceStudy Protocol DevelopmentFinal Study Report ReviewClient-Focused White PapersElectronic Safety Database
Soft Skills
Excellent Communication SkillsExcellent Organizational SkillsExcellent Time Management SkillsExcellent Presentation SkillsCollaboration
Tools & Technologies
WordExcelAccessElectronic Safety Database
Industry Keywords
CROPharmaBiotechGCPRegulatory RequirementsClinical DevelopmentSerious Adverse EventsMedical MonitorTherapeutic AdvancesMarketplace Developments

About the role

Key responsibilities & impact
  • Medically manage assigned clinical trials as Medical Monitor
  • Serve as Global Lead Medical Monitor for pan-regional and/or global trials
  • Collaborate with Medical & Safety project team members to process Serious Adverse Events
  • Provide therapeutic and protocol-specific training to project teams
  • Contribute medical input to clinical development programs, study protocols, research papers, and client-focused white papers
  • Provide after-hours medical support for assigned projects
  • Support Business Development through proposal generation, feasibility assessments, proposal/contract review, and sponsor meetings
  • Review or assist with final study reports and other study documentation
  • Maintain competence in assigned projects, therapeutic advances, and marketplace developments
  • Interact with other functional areas to ensure successful project execution and client satisfaction
  • Identify, document, and resolve out-of-scope work
  • Assist with departmental revenue targets and other senior-management-directed activities
  • Maintain compliance with ethical, legal, and regulatory standards
  • Mentor other medical staff and support department and company leadership
  • Maintain clinical and therapeutic acumen through scholarly programs and lectures
  • Perform SAE-related medical review in the electronic safety database
  • Perform other duties as assigned

Requirements

What you’ll need
  • Medical Degree from an accredited institution of Medical Education
  • 6-8 years in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role
  • Valid passport and ability to travel if required
  • Excellent computer skills (Word, Excel, Access)
  • Excellent spoken and written English skills
  • Excellent organizational and time management skills
  • Excellent communication skills
  • Excellent presentation skills
  • Working knowledge of GCPs and regulatory requirements relating to clinical development and safety
  • Competence with SAE-related medical review in WORLDWIDE's electronic safety database

Benefits

Comp & perks
  • Competitive benefits package depending on location
  • Transparent compensation and pay equity
  • Opportunity to work in an inclusive and equitable workplace