Pfizer Director, Clinician Medical Monitor in Hurley, United Kingdom
• 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.
• In addition to study level activities, 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.
• 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.
Primary Responsibilities :
STUDY SAFETY ASSESSMENT
• 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 Review Plan (SRP). Consistent with the SRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SRP. The specific components of safety data review are detailed in SOP SAF09 and the "Safety Data Review Guide - for Clinicians."
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Participates in 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.
• Communicates safety information to sites across the study and provides responses to questions on safety.
PROTOCOL DESIGN AND STRATEGY
• Provide medical input during development and updates to the clinical development plan.
• Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy.
• Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provides medical input into country feasibility.
SUPPORT TO STUDY TEAM
• Provides clinical input to protocol/study team 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).
• Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites (in collaboration with regional medical monitors [RMMs] when assigned to a study).
• Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
• Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
• Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
• Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or Pfizer.com).
• Provides protocol specific training to study team, investigators, clinical research associate, and others.
• Interact with healthcare professionals at sites (leveraging the RMMs when assigned) 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.
• Coordinates medical opinions with other physicians globally to ensure consistency.
• Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
SUPPORT TO PROGRAM TEAM
• 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.
• As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).
• Responsible for the on-time and within-budget execution of protocols.
• Support Regulatory Authority interactions accountable 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.
Required Skill Set:
Medical degree (M.D./D.O or equivalent) with valid license.
Proven experience in:
Documented experience in the pharmaceutical industry (biopharmaceutical industry or CRO, not necessarily in vaccine) related to clinical research programs and registration activities OR
Documented experience as an investigator in vaccine clinical studies in academic, NGO or public health institutions
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.
Documented work experience/knowledge of statistics.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.