Vice President, Global Medical Affairs

CTI Clinical Trial and Consulting Services

Vice President overseeing global medical affairs and clinical trials at CTI. Leading strategy and execution for drug development and consulting engagements.

Posted 7/7/2026full-timeCovington • Kentucky • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide executive medical oversight across global clinical trials (Phases I-IV)
Oversee medical monitoring activities including development and review of Medical Monitoring Plans
Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs), and other clinical parameters included in medical data review processes
Partner with Pharmacovigilance, Regulatory, and Quality Assurance teams to ensure compliance with global regulations
Serve as medical expert interacting with investigators, sponsors, and regulatory authorities
Support study design, protocol development, and feasibility assessments
Lead and contribute to RFP responses, including strategy, content, and medical positioning
Participate in bid defense meetings, client presentations, and capabilities discussions
Partner with Commercial/Sales teams to identify growth opportunities and expand client relationships
Provide strategic medical input to win new business and increase revenue
Represent the organization at industry events, conferences, and client meetings
Provide medical leadership for consulting engagements and drug development programs
Oversee development of clinical documents including protocols, CSRs, regulatory submissions, and publications
Serve as subject matter expert for advisory boards and client engagements
Ensure scientific integrity across all deliverables
Develop and execute Medical Affairs strategy aligned with company growth objectives
Oversee departmental budgeting, forecasting, and resource allocation
Ensure development and maintenance of SOPs and implementation of best practices, creating an environment of continuous improvement
Drive process improvements to enhance quality, efficiency, and client satisfaction
Oversee administrative policies and processes associated with managing the Medical Affairs function, ensuring team members meet foundational expectations of their role
Attract, develop and retain team members
Coach and mentor Medical Directors, and Medical Affairs staff, and others as needed
Drive performance management, succession planning, and team capability building
Provide training and ongoing education for internal teams

Requirements

What you’ll need

10 years of progressive experience in the CRO, pharmaceutical or biotech industry
Significant clinical research experience including medical monitoring
Deep scientific, regulatory, clinical trial or drug development experience
Thorough knowledge of relevant FDA and other international health authorities’ regulations and guidelines, including directly interacting with such authorities, and GCP and ICH guidelines
Demonstrated involvement in business development, RFPS, and bid defenses
Medical Doctor (MD) degree
Preferred experience: Prior leadership experience in a CRO environment
Experience across multiple therapeutic areas
Strong network within pharmaceutical and biotech sponsors
Board Certification

Benefits

Comp & perks

Generous health benefits
Vacation packages
Hybrid work from home opportunities
Paid parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Medical MonitoringClinical Trial ManagementProtocol DevelopmentSafety Data ReviewRegulatory SubmissionsSOP DevelopmentProcess ImprovementBudgeting and ForecastingFeasibility AssessmentsAdvisory Board Expertise

Soft Skills

Team LeadershipCoaching and MentoringClient Relationship ManagementStrategic ThinkingCommunication Skills

Certifications

Medical Doctor (MD)Board Certification