Role DescriptionThe Director Scientist is an important part of the Project Team, working synergistically with program and study level clinical lead/study physician as the expert in medical scientific aspects of the compound and its development.
The accountabilities are broad; however, the core accountabilities are the medical & scientific support for the development and implementation of early phase AstraZeneca sponsored clinical program strategy, externally sponsored collaborative research program strategy and studies, including clinical science support for initiating clinical trial(s), supporting clinical data review, interpretation of the study results and supporting final recommendations to senior management.
The Director Scientist may also provide expert input to process improvement initiatives, development of junior members of the team and provide strategic contributions to the global clinical scientist team, depending on the level of experience.
As a key member of the Global Project Team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca.Typical Accountabilities (scope of the activity dependent on level of experience)Program LevelThe Director Scientist will support the clinical lead or in some instances serve as clinical lead in clinical science aspects of the program.Assists the clinical lead for clinical input to the clinical development plan at all stages of the program.Leads/co-leads/supports (with Translational and Bioscience Leads) the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy.Leads (or supports) development of recommendations on further development strategies to internal committees.Leads (or supports, as required) the preparation of clinical and other data for governance and other presentations.Leads (or supports, as required) the preparation of program level documents such as the investigators brochure and DUSR.Provides scientific/medical guidance (or coordinates) to the study team, including the CRO team.Leads/supports the collaboration with the research scientists and translational scientists to provide clinical input to the development and review of data to support development of the pre-CDID compounds.Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy.Leads or supports the development and review of content and quality of publications and inputs to development of the publication strategy.Where required leads project specific reviews of the competitor landscape to inform the program strategy.Study Level (when assigned as clinical science resource for study)The Director Scientist will support the study lead or in some instances serve as the clinical lead for the study.Guides aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product profile.Leads (or supports as required) clinical data review and interpretation of the study and program level with input from the study or program Physician/Clinical lead.Attends (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol.Leads the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician.Leads, approves or provides input for the protocols, amendments, and other relevant strategic documents.
Acts as lead clinical reviewer for Clinical Study Reports.ExternalDevelops and builds investigator and site relationships to support site selection and study start up activities.Leads the development and implementation of the externally sponsored collaborative research (ESCR) strategy for a programme.
The clinical scientist is the link between the project team and all external clinical research for the programme.
For preclinical external research proposals, co-leads with the Bioscience Lead.Leads investigator/site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella studies and ESCR studies.Represents the project internally and supports oncology drug development externally as a medical scientific expert with key external experts.
Supports development of alliances as appropriate.Represents AstraZeneca as a support for external meetings such as advisory boards and Investigator meetings.Identifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key AstraZeneca stakeholders.#J-18808-Ljbffr