Job: Clinical Scientist- Infectious Disease, AstraZeneca, Gaithersburg, MD

General Information

Job title:
Clinical Scientist- Infectious Disease
Job location:
Gaithersburg, MD 20059 United States

Requisition code:
Date posted:
Job type:

Career path:

Scientific Discipline:

Job Description

• Support the clinical lead in clinical science aspects of the program
• Provide clinical input to the clinical development plan (CDP) at all stages
• Leads, approves or provides input for the protocols, amendments, and other relevant strategic documents.
• Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership
• Provide input and hold accountability for the development of crucial study level documents (i.e. Clinical study Protocol)
• Attends (in person or by TC) the Site Initiation Visits, to present the study design and protocol
• You will develop and design studies to determine the scientific and clinical viability of a particular drug or portfolio of drugs and interpret trial results, either as the head of a team, or by providing expert input.
• Co-leads (with Translational and Bioscience Leads) the team to integrate the biology, translational and clinical science into the program strategy
• Leads (or supports, as required) the preparation of clinical and other data for governance and other presentations
• Leads (or support, as required) the preparation of program level documents such as the investigators brochure and DSUR informed consent form.
• Leads/supports the collaboration with the research scientists and translational scientists to provide clinical input to the development and review of data to support development of the candidate drug investment decision compounds
• Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy
• Leads or supports the development and review of content and quality of publications and inputs to development of the publication strategy
• Where required leads project specific reviews of the competitor landscape to inform the program strategy

Job Requirements

• Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree
• Clinical drug development within a pharmaceutical/biotech or academic environment
• Proven team leadership experience in a clinical setting
• Advanced understanding of evolving clinical practice with the introduction of new therapies.
• Experience in working and leading in matrix teams
• Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and lead through conflict
• Problem solving and issues management
• Experience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.
• A good understanding of the pharmaceutical and clinical drug development process

(Job number: 3925376)