Clinical Scientist

JOB SUMMARYAccountable for ethical, medical and scientific rigor in conduct and reporting of assigned clinical studies across all stages of drug development and commercialization.  Responsible for medical and scientific quality in the design, planning, initiation and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  • Responsibility extends from first concept to regulatory filing and publication of completed studies
  • Accountable for incorporating relevant recent advances in the field into clinical research
  • Accountable, together with Clinical Managers, for the quality of corporate relationships with leading investigators and clinical sites on assigned protocols
  • Accountable, together with Clinical Managers, for deployment of appropriate measures to maintain speed of recruiting, enthusiasm and motivation of site staff
  • Accountable, together with Clinical Managers and team statisticians, for development of clinical research documents including for example clinical study synopses, protocols, statistical analysis plans, CRFs, informed consent templates, Data Management Committee charters, clinical study reports, and site selection strategies.
  • Responsible for validity, accuracy, relevance and completeness of medical and scientific content in clinical research and regulatory documents.
  • Responsible for original writing, editing and review of medical and scientific elements of clinical research and regulatory documents to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency
  • Responsible for investigator education on the medical and scientific aspects of assigned protocols
  • Accountable for validity of medical and scientific advice to Clinical-Regulatory team
  • Accountable for quality and timeliness of Medical Monitoring of clinical research
  • Responsible for Medical Monitoring, as assigned
  • Contributes to the development of global regulatory approval strategies
  • Responsible for establishing communications with prominent clinical investigators relevant to assigned projects
  • Participates in development of publication strategies, writing and editing of draft presentations and manuscripts, and interface with principal investigators
  • Attends appropriate scientific meetings to maintain awareness of research activities
  • . Supports the review of promotional, labeling, and training material pertaining to assigned product
  • Responsible for sharing scientific knowledge with the organization during continuing education sessions, at an adapted level of understanding

REQUIRED EDUCATION/EXPERIENCE/SKILLS:

  • MD with postgraduate training and board-eligible or board-certified in a specialty or relevant subspecialty, OR
  • PhD degree in biology or pharmacology with relevant postdoctoral experience

Minimal Requirements

  • Demonstrated track record of scholarship, independent research funding, publication, and membership in scholarly societies OR proven track record of successful protocol development, execution, and reporting in industry
  • Demonstrated industry experience in clinical research, including protocol and program design and execution, minimum 5 years preferred
  • In depth understanding of the clinical development process and its intricacies
  • Solid understanding of clinical trial design, biostatistics and data analysis
  • Demonstrated experience with ICH, GCP and applicable regulations
  • Excellent written and oral communication, interpersonal, and organizational skills
  • Initiative in producing high quality work product in a small company environment
  • Roll-up-the-sleeves attitude
  • Strong project management skills
  • Ability to understand, influence, collaborate, and lead in a diverse team-based organization
  • Competence with standard office computer software tools
  • Ability to align activities with company objectives

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.