Director Scientist, Oncology R&D, Early Clinical

Job title:

Director Scientist, Oncology R&D, Early Clinical

Company:

AstraZeneca

Job description

Location: Barcelona, Spain (On-site). 3 days working from the office and 2 days working from home.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 Level:The Director Scientist will support the clinical lead or in some instances serve as clinical lead in clinical science aspects of the programAssists the clinical lead for clinical input to the clinical development plan at all stages of the programLeads/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 strategyLeads (or supports) development of recommendations on further development strategies to internal committeesLeads (or supports, as required) the preparation of clinical and other data for governance and other presentationsLeads (or support, 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 teamLeads/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 compoundsFollows 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 strategyLeads or supports the development and review of content and quality of publications and inputs to development of the publication strategyWhere required leads project specific reviews of the competitor landscape to inform the program strategyStudy 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 studyGuides 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 profileLeads (or supports as required) clinical data review and interpretation of the study and program level with input from the study or program Physician/Clinical leadAttends (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 physicianLeads, approves or provides input for the protocols, amendments, and other relevant strategic documents. Acts as lead clinical reviewer for Clinical Study ReportsExternal:Develops and builds investigator and site relationships to support site selection and study start up activitiesLeads 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 studiesRepresents 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 andInvestigator meetingsIdentifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key AstraZeneca stakeholders as required.Other:Based on experience level, supervises and supports development of individuals within the team, including secondees and graduatesOperates in compliance with GCP and relevant regulatory guidelines.Education, Qualifications, Skills and ExperienceEssentialRelevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degreeClinical drug development or medical research experience demonstrated (
5 years) within a pharmaceutical/biotech or academic environmentProven 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 cancel cell biology.Experience leading delivery and influencing at senior leadership levels both internally and externallyExperience in working and leading in matrix teamsStrong collaborative communications skills including the ability to engage with a diverse internal and external client base and manage through conflictProven ability in problem solving and issues management that is solution focusedExperience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.Ability to support and mentor junior team membersDesirableA good understanding of the clinical and pharmaceutical drug development processDate Posted 04-sept-2024Closing Date 29-sept-2024AstraZeneca 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.

Expected salary

Location

Barcelona

Job date

Fri, 23 Aug 2024 04:44:22 GMT

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