Senior Group Director Scientist, Haematology R&D

The Senior Group Director Scientist fulfills the role of line manager toa number ofclinical scientists within Hematology R and D. The role will have a major responsibility to mentor/develop/line manage junior clinical scientist within Hematology. The role holder maybe requiredto serve as a member of the departmental leadership team, coordinate resourcetrackingand lead improvement initiatives in service of non-drug scorecardobjectives.

You will also fulfill the role of a Senior Clinical Scientist assigned to Hematology and in thatcapacityyou are an important part of the Project Team, working collaboratively with the program and study level physician or clinical lead 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), 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 expert input to other non-assignedprogrammes, process improvement initiatives, development of junior clinical scientist within Hematology andprovidesstrategic contributions to the global clinical scientist team.

As a key leadership member of the Global Project Team, this positiondemands 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 berequiredto line manage other Clinical Scientists including project allocations/resource management, recruitment & selection, personaldevelopmentand performance management

• May berequiredto serve as the Skills Lead for the Clinical Science group therebybeing responsible forensuringappropriate procedures, training and personal development approaches are in place for the skill group and best practice isidentifiedand implemented

• Contributes to the Departmental Leadership Team to ensure effective ways of working, identification and resolution of issues, departmental objective setting and mayextend toresource allocation and tracking at the departmental level

• Will lead or contribute to continuous improvement initiatives

• May berequiredto manage 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 theprogramme.

• Leads or co-lead (with Translational and Bioscience Leads) the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into theprogrammestrategy

• Leads/supports development of recommendation(s) on further development strategies to internal committees.

• Leads (or supports, asrequired) the preparation of clinical and other data for governance and other presentations

• Providescientific/medical guidance to the study team, including the CRO team.

• Leads 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 anddisseminatesupdates 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 inform the program strategy

• Asrequired, 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 asrequired), clinical data review and interpretation of the study and program level with input from the study or program Physician/Clinical Lead

• 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,approvesor 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 aprogramme. The clinical scientist is the link between the project team and all external clinical research for theprogramme. For preclinical external research proposals, co-leads with the Bioscience Lead.

• Leads investigator/site relationships for ESCR clinical proposal reviews, protocol review and approval, scientificoversightand discussions for academic basket/umbrella and ESCR studies

• Representsthe project internally and supports oncology drug development externally as a medical scientific expert with key external collaborators. Supports development of alliances asappropriate.

• Support due diligence activities for potential in-licensing or collaborative opportunities and provides recommendations to senior management

• Represents AstraZeneca asa supportfor external meetings such as advisory boards and

• Identifiesand manages risks within the ESCR portfolio, raises quality issues through theappropriate channels, maintainscommunications with key AstraZeneca stakeholders asrequired.

• Drives key strategic initiatives within and beyond the Early Clinical Oncology group

• Develops, coaches, mentors, motivates and inspires individuals within theorganisation

• Operates in compliance with GCP and relevant regulatory guidelines.

Minimum Qualifications:

• Advanced degree: PhD or PharmD with 12+ years of relevant industry experience and a proven track record in clinical development

Why AstraZeneca?

At AstraZeneca we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There is no better place to make a difference to medicine, patients, and society. We champion an inclusive culture that celebrates diversity and collaboration, and we are always committed to lifelong learning, growth, and development.

What’s Next?

Are you ready to bring transformative science to B-cell leukemia patients? We’d love to hear from you.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.