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Clinical Scientist

Salary undisclosed

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Responsibilities

  • In collaboration with a therapeutic area Medical Director or Scientific Director, the Clinical Scientist will contribute to the design, conduct, analysis, and reporting of clinical trials.
  • The Clinical Scientist will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a product.
  • Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development.
  • Attends congress and reviews literature to develop and augment expertise in therapeutic area
  • Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels.
  • Reviews competitive landscape and help identify and evaluate business development opportunities.
  • Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
  • Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program.
  • Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
  • Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
  • Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
  • Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
  • Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
  • Contributes to authorship of regulatory responses and may participate in meetings.

Qualifications

  • Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
  • Ability to provide input and direction to clinical research with appropriate supervision
  • Experience in rheumatic diseases especially lupus is preferred.
  • Strong desire to collaborate in a cross-functional setting.
  • Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols