Role Summary

The Global Clinical Lead functions independently and has direct experience with all the steps in designing and delivering results of clinical trials/programs by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical programs. 

The Global Clinical Lead:

• Identifies and advances new concepts and processes to provide innovative strategies to solve clinical issues.  By leading and obtaining consensus from Program/Clinical Project team members and VRD leadership, the Global Clinical Lead solves highly complex and specialized problems related to clinical research programs. 
• Applies technical/scientific expertise to resolve problems regarding the clinical components of documents (i.e., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents).
• Provides procedural and scientific subject matter expertise to v lead clinician medical monitors, clinical scientists and other clinical staff members.
• Is accountable for providing medical and scientific expertise and oversight for Clinical Programs/Projects and leads design, execution, monitoring, delivery and reporting all clinical studies within a Program.
• Contributes to the development of strategy for multiple studies/protocols designed to obtain worldwide approval for vaccines
• Mentors and/or manages more junior MM colleagues.

Role Responsibilities

Accountable for trial participant safety across a Program:

• Provides Program 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.
• Responsible for the development of and adherence to the Safety Surveillance Review Plans (SSRP) for vaccine development programs.
• Has oversight of the subject safety data for all studies within a Program and the review of cumulative safety data with the safety risk lead.
• Monitor Program safety issues and provide input to serious adverse events (SAEs) reports. Participates in discussion on benefit-risk analysis across functions.
• Leads or oversees leadership of the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
• Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
• Ensures the communication of safety information to sites across the Program.

Clinical Program and Protocol design and strategy:

• Responsible for development of the Clinical Development Plan for a particular Program
• Designs clinical studies to meet the stated objectives of a program. Assures that clinical trial objectives of each study fit with the clinical program strategy.
• Provides oversight to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provides oversight of team giving medical input into country feasibility.

Support study teams:

• Has oversight of clinical input to Program protocol/study teams for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team).
• Works with study teams to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing.
• Oversees Program and ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line reports in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately
• Ensures the medical and scientific validity of study reports, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, Pfizer.com).
• Supports Program specific training to study team, investigators, clinical research associate, and others.
• Oversees interactions of clinical team with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
• Interacts with DMCs and steering committees as required.  Is responsible for ensuring all mate