Vice President, Global Medical Affairs

Responsibilities

• 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

• 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