Clinical Scientist

The Clinical Scientist (CS) will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program.
They are responsible for working collaboratively with the Clinical Program Lead and Lead Study Clinician and will develop study strategies in support of the clinical plans.
The CS support includes multiple tasks within the categories of:
protocol and study design, strategy, and trainingdata review and interpretationstudy and/or program scientific and integrity oversightsafety review and communicationregulatory document, study report and publication preparation and reviewclinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.The CS may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead as needed.
1) PROTOCOL AND STUDY DESIGN
Create protocol training materials for site managementProvide specific medical/protocol training for site facing roles including monitors and Study ManagersProvide protocol training at the investigator meetingAssist in preparation for and participate in consultant and key opinion leader meetingsComplete clinical sections of the Site Reference ManualProvide input on country feasibility as delegated by the Clinical Program Lead and/or Lead ClinicianIndependently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician, Clinical Study Team Leads (CSTLs), Statisticians, and other relevant groups.Lead strategy discussions of moderate complexityCreate informed consent document templates, and review site prepared ICDsSupport the preparation of other clinical documents as required2) DATA REVIEW AND INTERPRETATION
Lead clinical input for and participate in study set up and design including data collection tools, data analysis, and database set-upProactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables throughout the processProvide input for the design of the Statistical Analysis Plan (SAP) and the clinical data outputResponsible for review of patient level data across a study and for coordinating with Lead Clinician for study level review as delegatedLead or participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB managementInterpret data and identify issues of moderate/difficult complexity in the dataIndependently prepares efficient plan for medical review of data and moderates data review independently3) STUDY MEDICAL OVERSIGHT
Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the studyProvides medical perspective in consultation with the CSTL during the development of the monitoring planAnswers specific site management protocol questions as neededAssists in medical issue resolution (study wide, escalated regional/site)Provides input during vendor selection for specific medical/protocol issues4) SAFETY
Report SAEs during Safety Review Team meetingsEnsure timely communication of safety issues to sitesReview and approval of patient narratives as delegated by the Lead Clinician5) REGULATORY AND PUBLICATIONS
Provide in-depth scientific/medical input, review and editing of clinical study reports (CSR).Provide full review of content and integrates information from literature and other sources as appropriate.Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)Participate with the Clinical Program Lead and publications team to determine publication strategiesPrepares audit responses as delegated by the Lead ClinicianParticipates in inspection readiness activities6) CLINICAL PROGRAM IMPLEMENTATION
Along with the Lead Clinician is accountable for the Medical/Safety/Scientific Design and Execution of a Study.
Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issuesInitiate and coordinate corrective action for major medical/safety/scientific study level issuesAlong with CSTL and with regard to medical/safety concerns, ensures study level issues are resolved.Collaborate with Lead Clinician and CSTL to arrive at major site level decisions based on input from the teamProvide input during budget creation to Clinical Program Lead and Lead ClinicianCoordinates with CSTL to maintain study timelines.Along with the CSTL and in agreement with the Clinical Program Lead/Lead Clinician and the Team, develops study level enrollment planAlong with the CSTL and other study team members, participates in training of Study Management Staff and monitoring staff.In collaboration with the CSTL and study team, ensures the clinical trial material requirements of the study are met.Ensure standard processes, tools, and procedures used consistently and globallyParticipates in developing training strategy for study with the study team members.Provide input into the preparation of study level training materials in collaboration with CSTL and team membersProvide input into the monitoring plan for study
Provide scientific and medical/technical support to ensure that monitoring plan addresses unique vaccine-specific activities supporting the endpoints of the trialEnsure execution of the global study management plan from a medical/safety/scientific perspective7) May provide mentoring support for other Clinical Scientists within the program.
8) Represents Vaccine Clinical Research and Development and may take the lead on company-wide, global process improvement initiatives, and champion's process enhancements and solutions for complex issues.
Leads change for Vaccine Clinical Research and Development on new company initiatives.
9) May collaborate with Clinical Program Lead and other team members on development of program strategy and Clinical Development Plan for a program or multiple programs.
QUALIFICATIONS
BA/BS Degree in science or health-related field
MS, PhD or Pharm D preferred
Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research fieldHas working knowledge of vaccine therapeutic areaHas demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documentsHas independently authored clinical protocols and other clinical study documentsHas experience with participating in and informally leading an operational teamApplies knowledge of internal/external business challenges to facilitate process improvementsHas ability to work independentlyHas working knowledge of statistics, data analysis, and data interpretationHas exceptional written and oral communication and cross-functional collaborative skillsIs proficient in MS Word, Excel, and PowerPointFluency in Mandarin desirable At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including: Paid parental leaveAccess to Health & Wellness appsCareer Growth Experiences programRecognition & rewards programPaid volunteer daysLife Insurance BenefitsPfizer Learning Academy access to top content providersAccess to flu vaccines & skin checksOptions to purchase additional leaveSalary 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.
We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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