Vice President, Global Medical Affairs

What You'll Do

• 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.

What You'll Bring

• 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.
• Prior leadership experience in a CRO environment.
• Experience across multiple therapeutic areas.
• Strong network within pharmaceutical and biotech sponsors.
• Board Certification.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

For more information, visit www.ctifacts.com.

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Equal Opportunity Employer/Veterans/Disabled