Associate Director, Clinician, Vaccines
Posted on Apr 5, 2021 by Pfizer
Primary purpose is to serve as a Clinician for the COVID19 vaccine program to assist in the global vaccine clinical development of this vaccine.
The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for specific 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.
Accountable for safety across a 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 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 indication.
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.
Leads/Contributes to protocol design and strategy:
Provide medical input during development and updates to the clinical development plan.
Designs or contributes to design of 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 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 (eg lab specifications).
Works with study team to ensure high quality of data, eg appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
With other clinical team/program members is 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/contributes to 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.
Works to 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.
Responsible for/contributes to the on-time and within-budget execution of protocols.
Supports the program team:
Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
Gains and maintains familiarity with the literature and research in the project area to input into program team discussions.
May co-author abstracts, posters, presentations and publications.
Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.
Interacts with regulatory authorities, key opinion leaders, and principal investigators:
Support Regulatory Authority interactions accountable for providing responses as needed.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders/Principal Investigators network for new trials.
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.
M.D. required, internal medicine or pediatric certification is highly desirable. Training and experience in infectious diseases or infection control experience in the hospital setting is a plus.
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.
Knowledge of Good Clinical Practice.
Experience in small molecule or vaccine clinical development and conduct of clinical trials for treatment or prevention of diseases is preferred.
Experience in assessment of adverse events and safety among patients participating in therapeutic clinical trials is preferred.
Experience in protocol design, interpretation, and/or medical monitoring.
General therapeutic area knowledge.
Excellent written and oral communication.
Capacity to adapt to a fast-pace and changing environment