Associate Director Scientist, Early Oncology Global Development
hace 2 meses
Location: Barcelona, Spain (3 days working from the office and 2 days working from home)
The AD Scientist is an important member of the Project Team, working under the supervision of a clinical lead/study physician or senior clinical scientist, supporting activities related to the 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 Astra Zeneca 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.
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 Astra Zeneca.
Typical Accountabilities
The following tasks would be performed under the guidance of the clinical lead, physician or a senior member of the Clinical Science team, with the expectation that over time the AD Scientist would function more independently.
Program Level:
- Assists with the clinical input to the clinical development plan at all stages of the program.
- Supports the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy
- Supports in developing recommendation(s) on further development strategies to internal committees
- Supports the preparation of clinical and other data for governance and other presentations
- Supports the preparation of program level documents such as the investigators brochure and DUSR.
- 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, with physician or senior clinical scientist support.
- Supports the collaboration with the Lead Bio-scientist and Translational scientist to provide clinical input to the development and review of data for input to the development of pre-CDID compounds
- Supports the development and review of content and quality of publications and inputs to development of the publication strategy
Study level (when assigned as clinical science resource for study):
- The AD Scientist will support the study lead or in some instances serve as the clinical lead for the study
- Supports 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
- Supports with clinical data review and interpretation at the study and program level with input from the study or program physician
- Supports the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician
- Supports the preparation of clinical and other data for governance and other presentations
- Supports medical and scientific input to specific studies as required by the program clinical lead/study physician
- Supports updates for the protocols, amendments, and other relevant strategic documents. Supports the review of the Clinical Study Report
External:
- Supports development of investigator/site relationships to support site selection and study start up activities
- Co-leads/supports the development and implementation of the externally sponsored collaborative research (ESCR) strategy for a program. The clinical scientist is the link between the project team and all external clinical research for the program.
- Co-leads/Supports investigator and site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella study and ESCR studies
- Identifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key Astra Zeneca stakeholders as required.
- Supports the physician/senior clinical scientist in representing the project internally and externally with key external experts. Supports development of alliances as appropriate.
Other:
- Based on areas of expertise, supports development of individuals within the team, including secondees and graduates via a buddy system
- Operates in compliance with GCP and relevant regulatory guidelines.
Education, Qualifications, Skills and Experience
Essential
- Relevant Clinical or Biomedical M.Sc. or relevant Pharmacy, Nursing, MSc/MRes degree
- Clinical drug development or medical research experience demonstrated (> 2 years) within a pharmaceutical/biotech or academic environment
- Basic knowledge of clinical oncology practice and the science of cancer, with the ability to rapidly acquire knowledge
- Experience supporting 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, influencing delivery and scientific engagement.
Desirable
- Relevant Clinical or Biomedical Ph.D
- A good understanding of the clinical and pharmaceutical drug development process
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