Clinical Scientist

Location
San Diego, CA, United States
Posted
Feb 19, 2021
Ref
oo4befwB
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

This position will support efforts in the strategy, planning, execution, and reporting of clinical trials. Main responsibilities include supporting the Global Development Lead and working with the cross-functional team to execute the trials according to the clinical development plan. This position will be responsible for the development of clinical protocols, analysis and interpretation of safety and efficacy data, and will contribute to the writing of study documents and regulatory submissions.

Essential Duties and Responsibilities
  • Contribute to the planning and design of clinical studies, in addition to the development of clinical plans in accordance to corporate objectives
  • Contribute to the clinical oversight and scientific review of clinical trial data
  • Conduct literature searches, interpret scientific literature, prepare analysis, interpret and summarize clinical data
  • Work in close collaboration with Clinical Operations to ensure translation of the clinical protocol into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans
  • Contribute and coordinate the writing and revision of clinical documents, such as study protocols, clinical study reports, investigator brochures, and other materials for regulatory submission
  • Assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
  • Support the development of program documents, including the clinical sections of various regulatory documents, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions
  • Acts as the clinical representative in variety of cross-functional teams

Qualifications
  • Advanced degree in scientific/life-sciences/clinical/nursing field. M.Sc., Ph.D. preferred
  • Minimum of 2-3 years of clinical development experience, technical/operational experience in planning, executing, reporting and publishing clinical studies within the pharmaceutical industry.
  • Demonstrated ability to review and summarize study data, including experience in preparing and presenting data
  • Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
  • Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
  • Excellent communication (oral and written), analytical, organizational, and project management skills
  • Ability to think strategically and creatively, function independently, deliver on timelines, have strategic insights and have a detailed knowledge of the activities, and procedures involved in clinical drug development
  • Experience with global clinical studies is a plus
  • Prior experience in Rare Disease or Neuromuscular Therapy is a plus
  • Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment