END DATE October 09, 2016

Associate Director Physician Early Clinical Development - Oncology

AstraZeneca Pharmaceuticals LP - Waltham, MA

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  • Company
    AstraZeneca Pharmaceuticals LP AstraZeneca Pharmaceuticals LP
  • Location
    Waltham, MA
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

The Associate Director Physician will deliver to the project team the Medical Scientific strategies of the Clinical Development Plan (CDP). Responsible for the 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. br br Position: br br * 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 br * Designs or manages the implementation of the medical strategy within Clinical Development globally br * Develop clinical evidence for functional relevance of targets in human disease br * Support qualification of pharmacodynamic/disease markers for early assessment of efficacy. br * Ensure that clinical input into the Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific quality br * Writes the study synopsis br * Maintains a high degree of understanding and awareness on new and emerging medical development br * Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans br * Liaises with the internal and external medical community to follow developments within areas of expertise br * Medical Lead for regulatory communication and preparation of higher level documents br * Ensures internal and external peer review of potential study/programme design br * As available, provide clinical strategic input to in-licensing opportunities