Associate Director, Medical Monitor, Vaccine Clinical R&D
Vor 5 Tagen
Associate Director, Medical Monitor, Vaccine Clinical R&D We're in relentless pursuit of breakthroughs that change patients' lives.
We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Role Responsibilities 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.
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).
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.
Communicates safety information to sites across the study and provides responses to questions on safety.
Support study team: 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.
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.
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.
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 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 /Principal Investigators network for new trials.
Qualifications Must have: Medical degree (MBBS or equivalent).
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/house officer" 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 paced and changing environment.
Preferred/Nice to have: 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.
Flexibility to join frequent late night/early morning teleconferences with international study teams.
All work is done in English but speaking Mandarin to support regional work highly desirable.
Ability to travel domestically or internationally occasionally as required.
Work Location Assignment: Hybrid At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including: Paid parental leave Access to Health & Wellness apps Recognition & rewards program Life Insurance Benefits Pfizer Learning Academy access to top content providers Access to flu vaccines & skin checks Options to purchase additional leave Salary packaging & novated lease options *Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate.
With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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Sydney, Österreich Pfizer, S.A. De C.V VollzeitAssociate Director, Medical Monitor, Vaccine Clinical R&DWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for...
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