Group Director-Early Clinical Development, Clinical Scientists

Are you passionate about science and have an extensive knowledge within clinical drug development? Are you also an experienced Leader that wants to combine your leadership skills with your knowledge within the Metabolic area? At AstraZeneca, we work at the cutting edge of science to develop the ground-breaking medicines of the future - here we do things that have never been done before. Does this match your skills and ambitions for the future? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic diseases!

We are now offering an exciting opportunity for a talented and highly motivated individual to join us in the role as Group Director within Clinical Scientists, Early Clinical Development (ECD) at CVRM. In this role, you will be working in a global, diverse and cross-functional environment where you will coach and mentor a fantastic team of skilled clinical scientists and also be the clinical scientific lead in early CVRM programs. This role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden), Cambridge (UK) or Gaithersburg (USA).



What you'll do

The role as Group Director within Clinical Scientists, Early Clinical Development is a mixed role between being a Group Director and being a Director Clinical Science. The mixture is 50/50. You will be a member of the Leadership Team and report directly to the Head of Early Clinical Development.

As a Group Director for Early Clinical Development (ECD) Clinical Scientists, you are responsible for mentoring and line managing Clinical Scientists which include performance management and professional development activities. Approximately 6-8 Clinical Scientists will report directly to you. In this role you will ensure that our core values and clinical development capabilities are developed and maintained among ECD clinical scientists within the Metabolism disease area.

In the role as Director Clinical Science, you will provide clinical scientific input in to projects in early CVRM. Director and Associate Director Clinical Scientists are resources for the Project Team, as delegates for the Medical Director, working synergistically with Medical Director on projects as experts in clinical scientific aspects of the drug and its development. Your accountabilities are broad and will depend upon the exact phase of development. A core accountability is the clinical & scientific support for the clinical development and the clinical trial design including endpoints and study population. Additional physician-delegate tasks include the set-up, conduct, reporting and regulatory submission of clinical trials, liaison with discovery, regulatory, translational and late clinical and commercial colleagues, input to regulatory documentation, external relationship management, and review of literature pertaining to the target and compound under development.



Main Duties and Responsibilities

In the role as Group Director, you are responsible for:

* Working in close partnership with your counterpart within Early Clinical development to develop the clinical scientist function and ensure a unified way of working cross teams
* Managing the performance of individuals effectively and identifies development opportunities for team members
* The clinical input via Early Clinical development scientists to Early CVRM projects, from pre-TSID to Ph2b, including all therapeutic modalities
* Securing adequate support to all CVRM clinical programs in collaboration with your counterpart within ECD across our three sites (Gothenburg, Cambridge, and Gaithersburg) via scientist resources including but not limited to, regulatory documentation and interactions, Innovative clinical trial design, clinical input on biomarkers for patient selection and human target validation, clinical patient segmentation strategy, clinical endpoint qualification, GNG criteria.
* Securing alignment of a Metabolic focus, pathophysiological understanding, translatability of pre-clinical models, and biomarkers across clinical, bioscience, Translational Science and Experimental Medicine in early CVRM and Late CVRM
* Being the clinical scientific lead in early CVRM programs as agreed with VP Early Clinical
* Ensuring and champion consistent medical & scientific aspects of the clinical study plans across the programme
* Providing clinical scientific leadership to data and safety reviews ensuring consistency throughout the process
* Input clinical scientific information to internal documentation such as risk management plans, Investigator Brochures and strategic planning documents
* Supporting key contacts with opinion leaders, and help develop alliances as appropriate
* Following important developments and trends in the medical & scientific literature
* Writing and checking content and quality of product related publications and input to development of publication strategy
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If you are interested, read more about the position and apply at:

https://careers.astrazeneca.com/job/gaithersburg/group-director-for-early-clinical-development-clinical-scientists/7684/18661811



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Welcome with your application no later than February 28th 2021.