Director, Clinical Scientist

Job Title: Director Clinical Scientist, Oncology R&D, Early Clinical

Location: Barcelona, Spain

As a Director Clinical Scientist, you will be a key member of the Clinical Development Project Team, working collaboratively with the program and study-level clinical lead/study physician as the expert in medical scientific aspects of a compound(s) and its development. You will provide medical & clinical scientific support for the development and implementation of early phase AstraZeneca sponsored clinical program strategy, externally sponsored collaborative research program strategy, and clinical study design and delivery; working with one of the broadest and deepest Oncology pipelines in the industry.

You will be responsible for designing and initiating clinical trial(s), supporting clinical data review and interpretation of study results then facilitating recommendations to senior management as you drive a compound through development. You will also input into process improvement initiatives, develop junior team members, and provide strategic contributions as part of the global clinical scientist team.

Program Level:

• Supports the clinical lead or serve as clinical lead in the clinical science aspects of the program and inputs to the clinical development plan (CDP) from lead-optimisation onwards
• Leads/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 strategy
• Leads (or supports) the preparation of clinical and related data for governance and other presentations including making development recommendations on strategies to internal committees
• Leads (or supports) the preparation of program level documents such as the investigators brochure and DSUR.
• Provides scientific/medical guidance (or coordinates) to the study team, including the internal or external operations teams implementing studies
• Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team ensuring all parties are aware the impact on the strategy
• Leads or supports the development and review of content and quality of publications and inputs to development of the publication strategy
• Leads the development and implementation of the externally-sponsored collaborative research strategy for a programme, being the link between the project team and all external clinical research for the programme, supporting alliances as appropriate.

Study Level:

• Supports the study lead or in some instances serves as the clinical lead for the study
• Guides aspects of the CDP, aligning study protocols, and ensuring linkage of trial data to target product profile
• Attends in person or by teleconference 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 physician
• Leads, approves or provides input for the protocols, amendments, 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

Other:

• May supervise and support the development of individuals within the team, including secondees and graduates
• Operates in compliance with GCP and relevant regulatory guidelines.

Essential Skills/Experience:

• Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree
• Clinical drug development or medical research experience demonstrated (> 5 years) within a pharmaceutical/biotech or clinical a cademic environment
• Proven 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.
• Experience leading delivery and influencing at senior leadership levels both internally and externally
• A good understanding of the clinical and pharmaceutical drug development process

When we put diverse teams in the same room, we unleash ambitious and creative thinking with the power to develop life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Why AstraZeneca?

At AstraZeneca, we are driven by our dedication to deliver accelerated growth and to make people's lives better. We thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. We are part of an inclusive and giving community, supporting each other on our journeys. We are intellectually stimulated by constant learning with potential for multiple, global careers and great rewards. If you have the passion and the drive to accelerate growth and make people's lives better, then this is the place for you.

Ready to make a difference? Apply now!

We are open to receiving applications no later than 25th May