• The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for global clinical vaccine trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or a set of clinical studies to support an investigational vaccine new license application or new indication, and to ensure patient safety.
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• The clinician medical monitor will participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and provide assistance to new business development on market opportunities and the target product profile
Responsibilities
Leads/contributes to protocol design and strategy:
• In collaboration with the Global Clinical Project Lead, Pfizer Vaccine Clinical Research & Development and colleagues in relevant functional lines, provide medical/clinical input during development and updates to the clinical development plan.
• Designs clinical studies to meet the stated objectives in the clinical program strategy to support licensure and/or new indication.
• Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
• Provides medical input into country feasibility.
• Ensures cross-program consistency in study design, assessments, and analysis as applicable.
Accountable for safety across a study:
• Provide study team with medical/clinical advice 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 Review Plan (SRP). Performs and documents regular review of individual subject safety data per the SRP and Pfizer procedures and policies, and performs review of cumulative safety data with the safety risk lead.
• Monitors study safety issues, provides input to serious adverse events reports, communicates
safety information to sites across the study and responds to medical questions from the site or study staff.
• Participates in the Safety Review Team and reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, program- or study-specific Data Monitoring Committee or other individuals or bodies involved with the study or set of studies within a program.
Supports the study team:
• Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team).
• Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
• Reviews and interprets efficacy and safety data from clinical trials in collaboration with the Global Clinical Project Lead and other colleagues in Pfizer Vaccines Clinical Research & Development; accountable for overall medical/scientific validity, quality, and timeliness of analysis, and delivery of a clinical study report.
• Provides protocol specific training to study team, investigators, clinical research associate, and others.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness,
etc.
Supports the program team:
• Under the direction of the Global Clinical Project Lead and/or Clinical Team Lead, authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
• May co-author abstracts, posters, presentations and publications. Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.
• Serves as a key member of the Program team, interfacing with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s). Interacts with regulatory authorities, key opinion leaders, and principal investigators:
• Supports regulatory authority interactions.
• Liaises with key opinion leaders and principal investigators.
Qualifications
MD degree (M.D./D.O or equivalent).
• 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.
• Training in infectious disease, pediatrics, internal medicine, or obstetrics and gynecology.
• Documented experience in the pharmaceutical industry, or equivalent, related to clinical research programs and registration activities in early through late stages of development. 5 or more years of experience in clinical development of vaccines is preferred.
• Possesses the ability to critically evaluate medical/scientific information; propose new concepts and innovative ideas in drug development.
• Understands the design, development, and execution of clinical programs and studies.
• Capacity to adapt to a fast-paced and changing environment
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