Senior Group Director Scientist Full-time

Senior Group Director Scientist

The Senior Group Director Scientist fulfills the role of line manager to a number of clinical scientists within Hematology Research and Development. The role will have a major responsibility to mentor junior clinical scientist within Hematology. The role holder may be required to serve as a member of the departmental leadership team, coordinate assets tracking and lead improvement initiatives in service of non-drug scorecard objectives.

You will also fulfill the role of a Senior Clinical Scientist assigned to Hematology and in that capacity you are an important part of the project Team, working collaboratively with the program and study level physician or clinical lead as their guide 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), protocol/amendment development, IB/DSUR submissions, clinical trial documents, supporting clinical data review, interpretation of the study results and providing/supporting final recommendations to senior management.

You will drive and provide guide input to other non-assigned programmes, process improvement initiatives, development of junior clinical scientist within Hematology and provides strategic contributions to the global clinical scientist team. As a key leadership 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 business partners both within and external to AstraZeneca.

• Will be required to line lead other Clinical Scientists including project allocations/resource management, recruitment & selection, personal development and performance management
• May be required to serve as the Skills Lead for the Clinical Science group thereby being responsible for ensuring appropriate procedures, training and personal development approaches are in place for the skill group and standard methodology is identified and implemented
• Contributes to the Departmental Leadership Team to ensure effective ways of working, identification and resolution of issues, departmental objective setting and may extend to prioritization and supervising at the departmental level
• Will lead or contribute to continuous improvement initiatives
• May be required to run key alliances (provider and academic) • As required you may be asked to act as Clinical Lead for the program/study or support the clinical lead • Leads or supports clinical input to the clinical development plan at all stages of the programme.
• Leads/co-lead (with Translational and Bioscience Leads) the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the programme strategy
• Leads/supports development of recommendation(s) on further development strategies to internal committees.
• Leads (or supports, as required) the preparation of clinical and other data for governance and other presentations
• Provide scientific/medical mentorship to the study team, including the CRO team.
• Is responsible for 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 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 advise the program strategy
• As required, the Group Director Clinical Scientist may be asked to act as Clinical Lead for the AZ sponsored 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
• Attends (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol
• 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
• Owns 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, Investigator Brochure, DSURs and other relevant strategic documents. Acts as lead clinical reviewer for Clinical Study Reports
• Develops 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 ESCR clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella and ESCR studies • Represents the project internally and supports oncology drug development externally as a medical scientific guide with key external collaborators. Supports development of alliances as appropriate.
• Support due diligence activities for potential in-licensing or collaborative opportunities and provides recommendations to senior management
• Represents AstraZeneca as a support for external meetings such as advisory boards and • Identifies and handles risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key AstraZeneca partners as required.
• Drives key critical initiatives within and beyond the Early Clinical Oncology group • Develops, coaches, mentors, motivates and encourages individuals within the organisation
• Operates in compliance with GCP and relevant regulatory guidelines.

Essential Requirements:

• PhD or Pharm D with at least 10 years experience in the industry
• Strong Experience working on clinical trials in Hematology -Oncology clinical trials experience required.
• Experience handling and interpreting the results of clinical trials as well as exposure to writing protocols
• Strong analytical skills
• Experience of authoring scientific documents
• Well-developed communication skills
• Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partner
• Proven track record of line management