[Dj] Associate Director, Medical Monitor, Vaccine Research And Development
vor 4 Stunden
[DJ] Associate Director, Medical Monitor, Vaccine Research and Development
Applylocations Japan - Tokyo Australia - New South Wales - Sydney
time type Full time
posted on Posted 30+ Days Ago
job requisition id 4922779
Role SummaryThe clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain approval particularly in Japan and other countries in Asia for a compound or group of compounds.Role ResponsibilitiesProtocol design and strategy: Contributes towards the medical input during protocol development and updates to the clinical development plan.Work closely with other medical monitors and Japan study team members 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).
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/Japan Clinical Lead 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.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.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 team:Works closely with Japan development teams providing medical input and knowledge throughout the program from inception through completion and regulatory approval.Under supervision (director/Sr director) authors clinical sections of regulatory documents.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, particularly with the PMDA.Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.QualificationsMust have: Medical degree (M.D or equivalent).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 in English and Japanese.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.Ability to travel domestically or internationally occasionally as required. Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
About UsPfizer careers are like no other.
In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.
We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
#J-18808-Ljbffr
-
Sydney, Österreich Pfizer VollzeitRole SummaryThe clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain approval particularly...
-
Sydney, Österreich Tideri Jobbörse VollzeitRole Summary The clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain approval particularly...
-
Sydney, Österreich Pfizer VollzeitRole SummaryThe clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain approval particularly...
-
Associate Director
vor 2 Monaten
Sydney, Österreich Kantar Group VollzeitAssociate Director - Qualitative Research Kantar is looking for an Associate Director to join our fantastic Qualitative team in Sydney!We are looking for someone who has qualitative expertise and can:Deliver the insight component of projects from beginning to end, using your qualitative skill sets along with culture and consumer sources to build...
-
Senior/Clinical Research Associate
vor 4 Wochen
Sydney, Österreich Southern Star Research VollzeitSouthern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.We recognise that attracting and retaining excellent staff is the key to developing...
-
Associate Director
vor 2 Monaten
Sydney, Österreich Tideri Jobbörse VollzeitAssociate Director - Qualitative Research Kantar is looking for an Associate Director to join our fantastic Qualitative team in Sydney!We are looking for someone who has qualitative expertise and can: Deliver the insight component of projects from beginning to end, using your qualitative skill sets along with culture and consumer sources to build...
-
Sydney, Österreich Cape Breton University VollzeitDirector of Faculty Development, Cape Breton Medical CampusCape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97EMPLOYMENT OPPORTUNITYPlease ensure you upload your resume and attach a cover letter in the correct upload area. Any other documents required please add to Additional Documents.Applications Close: January 10th 2025PURPOSE...
-
Sydney, Österreich Tideri Jobbörse Vollzeit3 days ago Associate Director/ Director, Account Development We are seeking a highly experienced and results-driven Associate Director/Director, Account Development to join our team at NIQ/GFK , a global measurement and data analytics company.Numerous multinational companies rely on us for accurate insights into consumer behavior and market trends.Our...
-
Associate Director
vor 2 Monaten
Sydney, Österreich Kantar Group VollzeitAssociate Director - Qualitative ResearchKantar is looking for an Associate Director to join our fantastic Qualitative team in Sydney!We are looking for someone who has qualitative expertise and can:Deliver the insight component of projects from beginning to end, using your qualitative skill sets along with culture and consumer sources to build...
-
Sydney, Österreich Tideri Jobbörse VollzeitDirector of Faculty Development, Cape Breton Medical CampusCape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97EMPLOYMENT OPPORTUNITYPlease ensure you upload your resume and attach a cover letter in the correct upload area.Any other documents required please add to Additional Documents.Applications Close: January 10th 2025PURPOSE...
-
Sydney, Österreich Tideri Jobbörse VollzeitDirector of Faculty Development, Cape Breton Medical Campus Cape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97 EMPLOYMENT OPPORTUNITY Please ensure you upload your resume and attach a cover letter in the correct upload area.Any other documents required please add to Additional Documents.Applications Close: January 10th 2025...
-
Sydney, Österreich Cape Breton University VollzeitDirector of Faculty Development – Cape Breton Medical CampusLocation: CBUCompetition Number: 97Deadline: January 24, 2025 at 11:59 pmCape Breton University and Dalhousie have partnered to establish the Cape Breton Medical Campus in Sydney, Nova Scotia, with the goal of enhancing healthcare delivery in rural communities.CBMC aims to train a new generation...
-
Sydney, Österreich Cape Breton University VollzeitDirector of Faculty Development, Cape Breton Medical CampusCape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97EMPLOYMENT OPPORTUNITYPlease ensure you upload your resume and attach a cover letter in the correct upload area.Any other documents required please add to Additional Documents.Applications Close: January 10th 2025PURPOSE...
-
Sydney, Österreich Cape Breton University VollzeitDirector of Faculty Development, Cape Breton Medical CampusCape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97EMPLOYMENT OPPORTUNITY Please ensure you upload your resume and attach a cover letter in the correct upload area.Any other documents required please add to Additional Documents. Applications Close: January 10th 2025...
-
Associate Director
Vor 6 Tagen
Sydney, Österreich Kantar Group VollzeitAssociate Director - Qualitative ResearchKantar is looking for an Associate Director to join our fantastic Qualitative team in Sydney!We are looking for someone who has qualitative expertise and can:Deliver the insight component of projects from beginning to end, using your qualitative skill sets along with culture and consumer sources to build...
-
Sydney, Österreich Tideri Jobbörse VollzeitDirector of Faculty Development, Cape Breton Medical CampusCape Breton University, 1250 Grand Lake Rd, Sydney, Nova Scotia, Canada Req #97EMPLOYMENT OPPORTUNITYPlease ensure you upload your resume and attach a cover letter in the correct upload area.Any other documents required please add to Additional Documents.Applications Close :January 10th 2025PURPOSE...
-
Sydney, Österreich University Of New South Wales VollzeitResearch Associate- Infection Analytics Program, The Kirby InstituteClinical/Medical Research (Healthcare & Medical)Other (Education & Training)Full timeRemuneration: Academic Level A ($88K -$117K) + 17% Super + Annual Leave LoadingTo be successful you will hold Australian Working Rights or Australian Citizenship.Visa sponsorship is not available for this...
-
Senior/Clinical Research Associate
vor 3 Monaten
Sydney, Österreich Southern Star Research VollzeitSouthern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.We recognise that attracting and retaining excellent staff is the key to developing...
-
Sydney, Österreich Dallas Va Research Corporation VollzeitResearch Associate in Biomaterials: The Graduate School of Biomedical Engineering (GBIOM) is offering a unique opportunity for a Research Associate in Biomaterials. This role is aligned with GBIOM's goals of innovation, incorporating the latest developments in nanotechnology into medicine. The successful candidate will contribute to collaborative research...
-
Clinical Research Associate
vor 4 Wochen
Sydney, Österreich Innovationaus.Com Pty Ltd VollzeitClinical/Medical Research (Healthcare & Medical) Full timeAdd expected salary to your profile for insightsLocation: Sydney/ Australia (hybrid - working from home and from the sponsor office during onboarding)As an experienced Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by...
