1+ months

Associate Director, Medical Monitor, Vaccines

Pfizer
Dover, FL 33527
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**About Us**



Pfizer is the world's leading Biopharma company and we're focused on breakthroughs in innovation and the development ofnew medicines that change patients' lives. We put patients at the heart of everything we do and have helped over 1 million patients in Australia alone last year with medicines and vaccines. Globally, we have over 90,000 colleagues and operate in over 125 countries worldwide.



Pfizer empowers colleagues to live the values of Courage, Excellence, Equity and Joy in the work we do every day to bring breakthroughs that change patients' lives. Through these values Pfizer is focused on creating an inclusive workplace that is collaborative, supportive and respectful.



**About You:**



You'll be a qualified Medical Doctor that's passionate about discovering breakthroughs that change patients' lives.



Your role will include the following:



**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** :



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 IRB/IECs.



Provides medical input into country feasibility.



With 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 by the study team.



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 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 c1oseout, audit responses, inspection readiness, etc.



**Supports the program team:**



Under 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**



**investigators:**



May 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



Relocation support available



The closing deadline for applications is July 02, 2021.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



\#LI-PFE
Posted: 2021-06-21 Expires: 2021-07-25
Sponsored by:
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Associate Director, Medical Monitor, Vaccines

Pfizer
Dover, FL 33527

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