Remote Regulatory Scientist

Found in: Jooble US O C2 - 2 weeks ago

San Diego CA, United States Avidity Biosciences Full time

P rincipal Scientist , Biomarker Sciences
San Diego and Remote
Full time
Development Sciences
Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit and engage with us on LinkedIn and Twitter .
Experience with clinical biomarker development , data analysis and regulatory interactions is required. Strong communication skills and the ability to work in cross-functional project teams are required. The primary role will be to develop and implement Biomarker Research plans for preclinical and clinical-stage program s . The ideal candidate should enjoy scientific research and collaboration in a fast-paced , interdisciplinary environment.
Partner with development team s on how to utilize biomarker data to support dose selection for Phase 2/3 studies.
Accountable for assay development, validation and analysis of clinical biomarker data by collaborating with internal stakeholders and external CROs .
Responsible for the interpretation of biomarker data and communication to project teams/senior management .
Responsible for the biomarker-related sections in clinical and regulatory documents (e.g., Establish collaborations with academic labs/KOLs to support Avidity’s drug pipeline .
Work closely with research teams to identify and develop biomarkers associated with disease progression, drug response and patient selection to support IND .
Mentor scientists within Research and Development on biomarker strategy and implementation .
PhD in B iology, P harmacology or related disciplines; Experience with assay development and analysis of multi-omics data .
Must demonstrate a high level of independence and the ability to develop hypotheses and direct analysis plans .
Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
10578 Science Center Dr.

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