ROLE RESPONSIBILITIES:Accountable for s a fety across the study:
- The Clinician Medical Monitor (CMM) is accountable for providing medical and scientific expertise and oversight for Global Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies to ensure patient safety. Additional study level activities include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer reviewed journals.
The CMM will also act as a medical monitor for select clinical trials, including phase 2B and phase 3 registration studies, The CMM is accountable for patient safety for subjects participating in Pfizer clinical trials and provides medical guidance during the design, execution, and reporting for clinical studies.
In addition to study level activities, the CMM will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety update and clinical sections of product labels. In addition to work on specific assets the CMM 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
Protocol design and strategy:
- 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 Surveillance Review Plan (SSRP). Consistent with the SSRP, 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 SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the "Safety Data Review Guide - for Clinicians."
- Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
- 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.
Support study team:
- Contributes towards the medical input during protocol development and updates to the clinical development plan.
- Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by I RB/I ECs.
- Provides medical input into country feasibility .
Supports the program team:
- With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, I CDs, clinical review forms, data edit checks, data quality planning, as needed
- 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.
- Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
- Contributes to 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 and accountable for overall quality and timeliness of analysis and reporting.
- Provides protocol specific training to study team, investigators, clinical research associate, and others.
- Interacts with healthcare professionals at sites during the conduct of the study to en a ble quality, compliance and patient safety at the trial, site and patient level.
- Interacts with DMCs and steering committees as required .
- Notifies 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.
Interact with regulatory authorities, key opinion
- Under supervision (Director/Sr Director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, lnvestigational New Drug sections, clinical study report).
- May co-author abstracts, posters, presentations and publications.
- May contribute budget execution of protocols .
leaders, and principal investigators:
- May su pport Clinical 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.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- MD degree
- 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.
- M.D. required, internal medicine or surgical certification is highly desirable. Training and experience in infectious diseases or infection control experience in the hospital setting is preferred
- Knowledge of Good Clinical Practice
- Experience in small molecule or vaccine clinical development and conduct of clinical trials for treatment or prevention of diseases in hospitalized patients is preferred
- Experience in assessment of adverse events and safety among hospitalized patients participating in therapeutic clinical trials is preferred
- Skilled in protocol design, interpretation, and medical monitoring
- General therapeutic area knowledge
- Excellent written and oral communication
- Capacity to adapt to a fast-pace and changing environment
Other Job Details:
- Travelmay be requiredfor team / site meetings
- Meetings outside of standard working hours may be required to accommodate a global team
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
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