Associate Director Scientist, Early Oncology Global Development

Location: Barcelona, Spain (3 days working from the office and 2 days working from home)

The Associate Director 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 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.

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

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 Associate Director Scientist would function more independently.

Study level (when assigned as clinical science resource for study):

The Associate Director 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

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 strategySupports 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

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 handles risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key AstraZeneca 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 PhD

A good understanding of the clinical and pharmaceutical drug development process.