Director Scientist, Early Global Development The 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)
Support the clinical lead or serve as clinical lead in clinical science aspects of the program.
Assist the clinical lead for clinical input to the clinical development plan at all stages of the program.
Lead/co-lead/support (with Translational and Bioscience Leads) the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy.
Lead (or support) development of recommendations on further development strategies to internal committees.
Lead (or support, as required) the preparation of clinical and other data for governance and other presentations.
Lead (or support, as required) the preparation of program level documents such as the investigators brochure and DUSR.
Provide scientific/medical guidance (or coordinate) to the study team, including the CRO team.
Lead/support 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.
Follow important developments and trends in the medical & scientific literature and disseminate updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy.
Lead or support the development and review of content and quality of publications and inputs to development of the publication strategy.
Where required, lead project specific reviews of the competitor landscape to inform the program strategy.
Study Level (when assigned as clinical science resource for study):
Support the study lead or serve as the clinical lead for the study.
Guide 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.
Lead (or support as required) clinical data review and interpretation of the study and program level with input from the study or program Physician/Clinical lead.
Attend (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol.
Lead the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician.
Lead, approve or provide input for the protocols, amendments, and other relevant strategic documents. Act as lead clinical reviewer for Clinical Study Reports.
External:
Develop and build investigator and site relationships to support site selection and study start up activities.
Lead 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-lead with the Bioscience Lead.
Lead investigator/site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella studies and ESCR studies.
Represent the project internally and support oncology drug development externally as a medical scientific expert with key external experts. Support development of alliances as appropriate.
Represent AstraZeneca as a support for external meetings such as advisory boards.
Identify and manage risks within the ESCR portfolio, raise quality issues through the appropriate channels, maintain communications with key AstraZeneca stakeholders as required.
Other:
Based on experience level, supervise and support development of individuals within the team, including secondees and graduates.
Operate in compliance with GCP and relevant regulatory guidelines.
Education, Qualifications, Skills and Experience
Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree.
Clinical drug development or medical research experience demonstrated (> 5 years) within a pharmaceutical/biotech or academic environment.
Proven team leadership experience in a clinical setting (2-3 years).
Advanced understanding of clinical practice across tumour types and how clinical practice is evolving with the introduction of new therapies. Understanding of cancer cell biology.
Experience leading delivery and influencing at senior leadership levels both internally and externally.
Experience in working and leading in matrix teams.
Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and manage through conflict.
Proven ability in problem solving and issues management that is solution focused.
Experience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.
Ability to support and mentor junior team members.
A good understanding of the clinical and pharmaceutical drug development process.
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