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Associate Director Clinical Scientist, Clinical Development

Ort Gaithersburg, Maryland, USA Cambridge, England, Vereinigtes Königreich Anzeigen-ID R-074995 Veröffentlichungsdatum 02/19/2020

Associate Director Clinical Scientist, Early RIA

Location: Cambridge, UK or Gothenburg, Sweden or Gaithersburg, US

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

Early Respiratory, Inflammation and Autoimmunity (Early RIA) within AstraZeneca is accountable for the discovery and the development (up to phase III) of drugs in the RIA arena. Early Clinical Development (ECD) consists of medical directors, medical/clinical scientists and clinical program directors, who, in a collaborative manner define the strategy, design clinical trials and translate scientific ideas to proof-of-concept in target populations.

We are now looking for an Associate Director Clinical Scientist to be a key component of the Project Team, working collaboratively with the medical director and clinical team as the authority in medical scientific aspects of the drug and its development during early phase.

The core accountabilities include driving components of the programme strategy, as well as the concept and design of clinical trials within the team. And being the scientific leaders in the development, interpretation and implementation of new endpoints.

You may set-up, conduct, reporting and regulatory submission of clinical trials. You will participate in or lead cross-functional workstreams with discovery, regulatory, clinical and commercial colleagues. You will input into regulatory documentation, external relationship management and review of literature pertaining to the product(s) under development.

Finally, you will play a role in leading cross-project activities to direct Early Clinical Development Strategy (i.e. development of endpoints, strategies to demonstrate data, collaborations, target validation).

Responsibilities

Guide the science side of the Clinical Development Plans (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product claims / profile.

Make scientific input to the design (target population, translational biomarker selection and low reference value/target value characterization). Provide clinical scientific leadership to data and safety reviews (may serve as medical monitor) ensuring consistency throughout the process.

Represent AstraZeneca as a support for steering/organizing committees, investigator meetings, regulatory authority interactions and external product specific advisory boards for the Project/Product.

Initiate and support contacts with opinion leaders and help develop alliances.

Write and check content and quality of product related publications and input to development of publication strategy.

Other responsibilities will include:

  • Co-ordinate Therapeutic Area leadership for regional/global investigator (non-) AZ-sponsored study programs.
  • Support the development and strategy of exploratory clinical studies as needed, to support Therapeutic Area strategy, including design, set up, conduct and reporting.
  • Follow developments and trends in the clinical & scientific literature to contribute and direct strategy across Early RIA Clinical Development.

Requirements

Essential

  • Relevant Clinical or Biomedical Ph.D or Pharmacy, Nursing, MSc/MRes degree
  • Experience in drug development, medical affairs or medical research within a company environment
  • A degree of specialist knowledge of the medical and scientific activities related to a therapeutic area/indication and/or to a project or product
  • An understanding of more than one development function

Desirable

  • RIA Scientific & Medical understanding
  • Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
  • Ability to credibly influence whilst maintaining independent and objective views
  • Communication, interpersonal and organizational skills
  • Attention to detail
  • Analytical thinking
  • Cultural awareness
  • Commercial acumen

Next Steps – Apply today!

Applications Open: 19 February 2020

Applications Close: 6 March 2020



AstraZeneca 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 authorisation and employment eligibility verification requirements.

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