Director, Vaccines Clinical Research (MD required)
Pfizer · Pearl River, New York, US
ROLE SUMMARY - The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a...
Job description
ROLE SUMMARY: - The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. - The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. - In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES: Accountable for safety across the study - Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. - Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). - Consistent with the SSRP, performs and documents regular review of in...