Essential Functions:

• Provide direct medical monitoring or medical safety oversight of CRO medical monitors.
• Provide clinical input on protocols, IBs, ICFs, INDs, safety reports, monitoring plans, review forms, data edit checks, and data quality planning.
• Provide protocol-specific training to the study team and Investigators.
• Advise the study team on medical issues during risk assessment and mitigation, ensuring quality, compliance, and study participant safety.
• Work with the study team to ensure protocol adherence and data integrity.
• Ensure high-quality data by verifying patient population and adequacy of clinical assessments.
• Review and interpret clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the Clinical Operations and Data Management groups, and make recommendations and determinations as appropriate and required to help ensure the protection of study participants.
•  Responsible for the preparation, analysis, and presentation of safety data as part of the Internal Safety Team (IST) and to the Data Safety Monitoring Board (DSMB).
• Ensure compliance with regulatory reporting requirements for safety reporting in conjunction with Regulatory Affairs.
• Represent Vaxcyte externally to trial site Investigators and administrators.
• Comply with Vaxcyte’s SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Collaborate on topline data reporting and clinical study reports.
• Support the study team in issue resolution, study closeout, audit responses, and inspection readiness.
• Co-author abstracts, posters, presentations, and publications.
• Develop and maintain strong, collaborative relationships with the broader Vaxcyte organization.

Requirements:

• MD (active medical license is preferred) with both early and late-stage drug development experience desired. Minimum of 3 years of industry experience required.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies are desirable.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Strong analytical, problem-solving skills, and strategic planning skills required.
• Must be accurate, detailed and committed to high quality standards and proactive in finding solutions to achieve successful outcomes.
• Highly capable of following organizational plans, goal setting, resource management, contingency planning, coordinating and collaborating with others.
• The ideal candidate will be a results-driven team player and must thrive in a fast-paced, dynamic environment.  Must have the ability to drive results, possessing a strong drive to meet and exceed goals and be willing to take ownership of problems and make or recommend sound decisions.