Principal Clinical Scientist
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 provide scientific support to one or more clinical programs in the strategy, planning, execution, and reporting of clinical trials. Main responsibilities include supporting the Global Development Lead (GDL) and working with the cross-functional team to execute the trials according to the clinical development plan (CDP). In collaboration with the GDL, this position will contribute to the overall development strategy, lead the development of clinical protocols, analyze and interpret safety and efficacy data, and contribute to regulatory submissions, publications and presentations.Essential Duties and Responsibilities
- Contribute to the planning and design of clinical studies to meet the CDP objectives
- Lead and coordinate the writing of synopses, protocols, and amendments
- Contribute to the clinical oversight and scientific review of clinical trial data including safety and efficacy
- Contribute and coordinate the writing and revision of clinical documents, such as clinical study reports, investigator brochures, ICFs, study manuals and other materials
- 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
- Acts as the clinical representative in variety of cross-functional teams
- Prepare high quality presentations on Avidity technology, clinical trial design and plans to site investigators and staff
- Determine appropriate advisory boards experts and lead the team in preparation for meetings
- Develop and maintain strong working relationships with KOLs, site investigators and staff
- Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
- Advanced degree in scientific/life-sciences/clinical/nursing field. (M.Sc., Ph.D., Pharm D, MPH or similar degree) required
- Minimum of 5 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