• Poland
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  • 3 - 6 Years
  • Posted : above 1 month

Job Description:

At AstraZeneca we are guided in our work by a strong set of values, and were resetting expectations of what a bio-pharmaceutical company can be By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together From scientists to sales, lab techs to legal, were on a mission to turn ideas into life-changing medicines that transform lives We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world If youre swift to action, confident to lead, willing to collaborate, and curious about what science can do, then youre our kind of person

We are now recruiting a Scientist/ Senior Project Scientist within the Early Respiratory, Inflammation and Autoimmunity (Early RIA) and the Early Cardiovascular, Renal, Metabolism (Early CVRM) Clinical Development Group, in Early RIA/CVRM BioPharmaceuticals R&D Early clinical area within AstraZeneca is accountable for the discovery and the development (up to phase III) of new drugs in the RIA/ CVRM arena Clinical Development within Early RIA/CVRM consists of experienced medical directors, clinical scientists and clinical program directors, who, in a collaborative manner, define clinical development strategy, design innovative clinical trials and translate novel scientific ideas to proof-of-concept in target populations

Clinical Scientists are a key component of the Project Team, working synergistically with the medical director and clinical team as the expert in medical scientific aspects of the drug and its development during early phase Accountabilities are broad, but core accountabilities include 1- driving components of the individual clinical programme strategy, as well as the overall concept and design of clinical trials within Early RIA or CVRM Clinical Development Team; 2- being the scientific leaders with regards to development, interpretation and implementation of new endpoints Additional tasks may include the set-up, design, conduct, reporting and regulatory submission of clinical trials; participation and leadership of cross-functional workstreams with discovery, regulatory, clinical and commercial colleagues; input to regulatory documentation, external relationship management and review of literature pertaining to the product(s) under development Finally, the Clinical Scientist will play a crucial role in leading cross-project activities to direct Early Clinical Development Strategy (ie development of novel endpoints, strategies to leverage clinical data, innovative external collaborations, target validation) These individuals comply with the highest ethical, safety standards and with GCP, regulatory & appropriate pharmaceutical code requirements The job-holder can expect to get broad international exposure to other functions involved in the drug development process within AZ, gaining an overview of how strategic direction is set and how decisions are made during drug development

Depending on the competence and experience of the Clinical Scientist, and the needs of the specific project, they may take on tasks as described below (not limited to these)

Lead/guide clinical science aspects 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,
Lead clinical scientific input to the set-up, design, conduct, reporting and regulatory submission of clinical trials,
Provide clinical scientific leadership to data and safety reviews (may serve as medical monitor) ensuring consistency throughout the process,
Lead/guide cross-functional scientific projects relating to clinical endpoints, biomarkers and digital / AI strategies, including design, interpretation and reporting,
Lead clinical scientific input to internal / external documentation such as risk management plans, Investigator Brochures and strategic planning documents,
Represent the Project / Product and indication area internally (global and marketing companies) and support externally as a clinical scientific expert,
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 key contacts with opinion leaders, and help develop alliances as appropriate,
Write and check content and quality of product related publications and input to development of publication strategy,
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 important developments and trends in the clinical & scientific literature to provide value and direct strategy across Early RIA or Early CVRM Clinical Development,
Lead cross-project activities to provide value to Early RIA or Early CVRM Clinical Development such as development and understanding of current, new and novel endpoints; strategies to leverage clinical data and / or innovative external collaborations

Qualifications

Relevant Clinical or Biomedical PhD or relevant Pharmacy, Nursing, MSc/MRes degree with >3 years R&D drug development experience
>3 years clinical drug development or medical affairs experience within a pharmaceutical company environment
A degree of specialist knowledge of the medical and scientific activities related to a particular therapeutic area/indication and/or to an assigned project or product
A good understanding of more than one development function
A clear demonstration of behaviours of truth seeking rather than success seeking, agile responsiveness to scientific data, embracing of peer review, agnostic to internal-external sourcingredibility in scientific environments
RIA or CVRM 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

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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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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