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.

• 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.

• 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.

• 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 materials are provided to DMC
• Coordinates medical opinions with other colleagues globally to ensure consistency at program level
• Ensures that appropriate study team colleagues are notified to inform investigators of any changes in research activity and any significant new adverse events.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

• Leads or oversees Clinical Program/Project teams, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Clinical Operations, and other members of the extended project team(s) to develop and align of clinical development strategy.
• Ensures that the clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report) are completed in a timely manner.
• May co-author abstracts, posters, presentations and publications.
• Ensures communication and escalation with Franchise Lead

• Participate in Clinical Regulatory Authority interactions responsible for providing responses.
• Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

• Medical degree (M.D./D.O. or equivalent).
• 7 years' experience in the pharmaceutical industry related to clinical research programs and registration activities with a minimum of 3 years of vaccines research and development experience
• Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
• Possesses the ability to critically evaluate medical/scientific information. Propose new concepts and innovative ideas in drug development.
• Excellent written an oral communication.
• Understands the design, development, and execution of clinical programs and studies.
• Capacity to adapt to a fast pace and changing environment.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
• Documented experience in the pharmaceutical industry related to vaccine clinical research programs and registration activities.

• Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
• Documented work experience/knowledge of statistics.