Pfizer
Associate Director, Clinician, Medical Monitor - Vaccines (MD required)
Pfizer, Pearl River, New York, United States, 10965
Associate Director, Clinician, Medical Monitor - Vaccines (MD required)
ROLE SUMMARYThe clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials.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.ROLE RESPONSIBILITIESAccountable for safety across the studyProvide 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.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 strategyContributes 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.Provides medical input into country feasibility.Support study teamWith supervision of medical monitor (director/Sr director) 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.Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines.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.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 enable 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.Supports the program teamUnder supervision (director/Sr director) 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.May contribute budget execution of protocols.Interact with regulatory authorities, key opinion leaders, and principal investigatorsMay support 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.BASIC QUALIFICATIONSMedical 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).0-4 years' work experience.Possesses the ability to critically evaluate medical/scientific information.Excellent written and oral communication.Understands the design, development, and execution of clinical programs and studies.Capacity to adapt to a fast pace and changing environment.PREFERRED QUALIFICATIONSDocumented work experience/knowledge of statistics.Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.Experience with investigational clinical trials is preferred.No pharmaceutical industry experience required.Candidate demonstrates a breadth of diverse leadership experiences and capabilities.Work Location Assignment:
On Premise.The annual base salary for this position ranges from $173,300.00 to $288,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program.We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.Relocation assistance may be available based on business needs and/or eligibility.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.Medical#LI-PFE
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ROLE SUMMARYThe clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials.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.ROLE RESPONSIBILITIESAccountable for safety across the studyProvide 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.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 strategyContributes 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.Provides medical input into country feasibility.Support study teamWith supervision of medical monitor (director/Sr director) 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.Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines.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.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 enable 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.Supports the program teamUnder supervision (director/Sr director) 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.May contribute budget execution of protocols.Interact with regulatory authorities, key opinion leaders, and principal investigatorsMay support 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.BASIC QUALIFICATIONSMedical 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).0-4 years' work experience.Possesses the ability to critically evaluate medical/scientific information.Excellent written and oral communication.Understands the design, development, and execution of clinical programs and studies.Capacity to adapt to a fast pace and changing environment.PREFERRED QUALIFICATIONSDocumented work experience/knowledge of statistics.Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.Experience with investigational clinical trials is preferred.No pharmaceutical industry experience required.Candidate demonstrates a breadth of diverse leadership experiences and capabilities.Work Location Assignment:
On Premise.The annual base salary for this position ranges from $173,300.00 to $288,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program.We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.Relocation assistance may be available based on business needs and/or eligibility.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.Medical#LI-PFE
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