Senior Clinical Research Scientist

Job title: Senior Clinical Research Scientist

Company: Resource Logistics

Job description: Job Description
Job title -Senior Clinical Research Scientist
Location- Durham NC and Gaithersburg, or remote. 100% remote
Ideal candidate will have Previous AZ working experience is preferred.

As a Senior Clinical Research Scientist within Late R&I Clinical Development for the clinical COVID-19 team, you will provide scientific and clinical input to late stage product development. This includes design, delivery, monitoring, and interpretation of pivotal clinical trials and mechanistic studies.

Your role will be focused on late stage COVID-19 clinical trials within R&I, where you will collaborate with the team with all aspects of scientific input, clinical data quality metrics and safety evaluation. You will also support and contribute to medical monitoring of trials as well as lead the development of metrics and data review plans for assigned studies.

Collaboration with colleagues within and beyond Late R&I will be crucial for you to be successful in your role and you will work closely together with colleagues from Patient Safety, Regulatory Affairs, Clinical Operations, Biometrics, and Early Development Groups.

We will rely on you to:

• Provide scientific expertise into the COVID-19 clinical development plans
• Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities
• In collaboration with a medical writer, be responsible for study related documents, including protocols
• Provide authoritative scientific analysis and interpretation of data from ongoing studies and from literature
• Lead and participate in activities that ensure quality, consistency and integration of clinical study results and ensure safety evaluation process within the clinical team

Essential for the role
You have a medical or scientific background and hold MSc, MD, PhD or PharmD or equivalent. This is complemented by considerable proven experience in Respiratory or Immunology disease clinical trials from pharmaceutical industry and/or academia.

Additionally, you possess:

• Good transferable project experience across phases late stage drug development
• Strong analytical skills and experience in managing and interpreting clinical trials results
• Experience of authoring scientific documents, including contributing to or writing protocols and key study and process documents
• High level of technical and disease area knowledge, enabling you to confidently interact with internal and external partners
• Excellent verbal and written communication, including presenting scientific results to multidisciplinary teams and key partners

Desirable for the role

• Experience of leading and managing cross functional collaboration activities and a passion for customers
• Vaccine and/or mAb clinical development experience

Expected salary:

Location: Durham, NC

Job date: Sat, 27 Mar 2021 07:37:27 GMT


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