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Associate Director Physician - Early RIA

Lieu Gaithersburg, Maryland, États-Unis Royston, Angleterre, Royaume-Uni Job ID R-090612 Date de publication 09/16/2020

The Associate Director Physician will deliver to the project team the Medical Scientific strategies of the Clinical Development Plan (CDP). Responsible forthe design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for acting as a renowned expert in own disease/drug field.

Key Accountabilities:

  • Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product in compliance with GCP
  • Designs or manages the implementation of the medical strategy within Clinical Development globally
  • Develop clinical evidence for functional relevance of targets in human disease
  • Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
  • Ensure that clinical input into the Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific quality
  • Writes the study synopsis
  • Maintains a high degree of understanding and awareness on new and emerging medical development
  • Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
  • Liaises with the internal and external medical community to follow developments within areas of expertise
  • Medical Lead for regulatory communication and preparation of higher level documents
  • Ensures internal and external peer review of potential study/programme design
  • As available, provide clinical strategic input to in-licensing opportunities

Education, Qualifications, Skills and Experience:

  • Graduate of a recognised school of medicine with an M.D. degree or equivalent, PhD preferred but not essential
  • >2 years clinical research expertise in relevant therapy area, in designing, monitoring and implementing clinical trials and interpreting trial results
  • Specialty training or board eligibility, preferably in Respiratory or Inflammation
  • Significant leadership experience
  • Proven teamwork and collaboration skills

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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