OBS! Ansökningsperioden för denna annonsen har
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 & Immunology (Early R&I) within AstraZeneca is accountable for the discovery and the development (up to phase III) of drugs in the R&I arena. Early Clinical Development (ECD) consists of medical directors, 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 dedicated individuals to join the Early Clinical Development team as Associate Director/Director Clinical Scientist.
What you will do
In your role you will be a key component of the Project Team, working together 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 or leading components of the programme strategy, as well as the concept and design of clinical trials within the team. Act as the scientific leaders in the development, interpretation and implementation of new endpoints.
You may support or drive parts of the 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 provide or drive 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, implementation of digital strategies, strategies to demonstrate data, collaborations, target validation).
Guide or own 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). You will be responsible for providing clinical scientific leadership to data and safety reviews (may serve as medical monitor) ensuring consistency throughout the process.
Represent AstraZeneca or support for steering/organizing committees, investigator meetings, regulatory authority interactions and external product specific advisory boards for the Project/Product.
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.
Director Clinical Scientist
Apart from above act as a leader when needed to drive, deliver and influence the CDP and Clinical Study Protocols. Where required, lead project specific reviews of the competitor landscape to advise program strategy and build network internally and externally at senior leadership level to gain scientific insight to reinforce Therapeutic Area strategy.
* 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
Clinical Director Scientist
* Minimum 3 years in similar role
* R&I Scientific & Medical understanding
* Ability to acquire and assimilate knowledge in different fields, disease and therapeutic areas
* Ability to credibly influence whilst maintaining independent and objective views
* Excellent Communication, interpersonal and organizational skills
* Attention to detail
* Analytical thinking
* Cultural awareness
* Commercial acumen
So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
We welcome your application on August 20th, 2020 at the latest!
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