Pfizer
Director, Clinical Research (MD required)
Pfizer, Pearl River, New York, United States, 10965
Director, Clinical Research (MD required)ROLE SUMMARY
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.
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.
In addition to study level activities, the clinician medical monitor may 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.
ROLE RESPONSIBILITIES
Accountable for safety across the 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 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.
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.
Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy.
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.
Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements.
Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
Conducts medical review and interpretation of efficacy and safety data from clinical trials.
Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
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.
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.
Supports the 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.
May contribute budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators:
Supports Clinical Regulatory Authority interactions accountable for providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials.
QUALIFICATIONS
BASIC QUALIFICATIONS
Licensed by a health authority to prescribe medicines for at least one year.
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.
Documented experience in the pharmaceutical industry related to clinical research programs and registration activities.
Responsible for managing multiple studies.
PREFERRED QUALIFICATIONS
Medical degree (M.D./D.O. or equivalent).
Documented 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.
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.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $213,500.00 to $355,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program.
Relocation assistance may be available based on business needs and/or eligibility.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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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.
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.
In addition to study level activities, the clinician medical monitor may 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.
ROLE RESPONSIBILITIES
Accountable for safety across the 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 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.
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.
Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy.
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.
Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements.
Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
Conducts medical review and interpretation of efficacy and safety data from clinical trials.
Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
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.
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.
Supports the 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.
May contribute budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators:
Supports Clinical Regulatory Authority interactions accountable for providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials.
QUALIFICATIONS
BASIC QUALIFICATIONS
Licensed by a health authority to prescribe medicines for at least one year.
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.
Documented experience in the pharmaceutical industry related to clinical research programs and registration activities.
Responsible for managing multiple studies.
PREFERRED QUALIFICATIONS
Medical degree (M.D./D.O. or equivalent).
Documented 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.
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.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $213,500.00 to $355,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program.
Relocation assistance may be available based on business needs and/or eligibility.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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