Company Overview

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

Position Overview

We are seeking a seasoned translational scientist to join the biomarker team at Avidity Biosciences in La Jolla, CA.  Experience with clinical biomarker development is required.  The ideal candidate will be a strategic and critical thinker responsible for developing and implementing biomarker strategy to demonstrate drug activity in first-in-human studies.  Strong communication skills with an ability to work in cross-functional project teams is required. This is a key position in the biomarker group to manage a group of scientists and RAs to drive biomarker discovery and assay development across several projects in research and development. Technical expertise in developing fit-for-purpose clinical biomarker assays across various assay platforms is highly desirable. He/She should enjoy scientific research and collaboration in a fast-paced interdisciplinary environment.

Responsibilities

• Lead the development and execution of clinical biomarker strategy to support dose selection, demonstrate pharmacodynamic activity and mechanism of action in FIH studies
• Oversee assay development, validation and analysis of clinical biomarker samples by collaborating with internal stakeholders and external CROs
• Responsible for the interpretation of biomarker data and communication to project teams/senior management
• Actively participate and contribute to cross-functional program teams and lead biomarker sub-teams to achieve project goals and timelines
• Responsible for the biomarker-related sections in clinical and regulatory documents (e.g., clinical protocols, ICFs, INDs, IBs, CSRs)
• Identify and develop novel biomarker assays/platforms to support biomarker discovery
• 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
• Manage a team of scientists and RAs in biomarker group

Qualifications

• PhD in Biology, Pharmacology or related disciplines; minimal of 8 years of industry experience with significant hands-on experience in translational medicine and biomarker development
• Knowledge of neuromuscular diseases and RNA therapeutics is highly desirable but not required.
• Experienced in developing fit-for-purpose biomarker assays that are compliant with current regulatory requirement and quality standards
• Experience with a variety of assay platforms (e.g, genomic assays, ddPCR, RT-qPCR, ELISA, MSD)
• Knowledge of biomarker sample logistics, data transfer and data reporting in clinical studies
• Excellent communication and interpersonal skills, problem-solving skills, strategic and independent thinking
• Must demonstrate a high level of independence and the ability to develop hypotheses and direct analysis plans
• Proven ability to manage and motivate scientists

Salary Range: $170,000 - $200,000