Description

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

DM1 Study - This position manages overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management.  They will lead the development of study operational plans and provide input into other functional area plans and processes as needed.  They will provide oversight of the CRO, vendors and sites as well as ensure compliance with GCP and regulatory guidelines.

Essential Duties and Responsibilities

• Performs job with minimal supervision

• Acts as the clinical operations representative in a variety of cross-functional teams

• Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
• Independently manage clinical study vendors
• Establish key deliverables and KPIs in management of CRO and vendors
• Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments and CRO, as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Responsible for management and/or oversight of eTMF structure, plans and quality.
• Manage study activities including, but not limited to, investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks, study drug accountability and study closeout.
• Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.
• Lead and/or collaborate with functional team members to draft/revise, finalize, and implement project plans, study-specific training, system builds, CRF designs, UATs.
• Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.
• Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• Leads and/or contributes to department process improvements/initiatives and SOPs
• Provide direction and mentoring to junior team members.
• Escalate pertinent CRA performance and site compliance issues when necessary

• May have line management responsibilities

• Performs other duties as assigned by management

Qualifications

• Bachelor’s degree required, preferably in the Life Sciences or equivalent
• Minimum of 5+ years of experience in clinical operations is required
• Experience managing a CRO as well as a complex study in a previous Clinical Trial Manager (or equivalent) position is required
• Global Clinical Trial experience in Phase 2 and/or Phase 3
• Experience in Rare Disease or Neuromuscular drug development is a plus
• Inspection readiness and inspection experience is a plus
• Exceptional attention to detail and organizational skills
• Excellent communication (oral and written), analytical, and project management skills
• Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
• Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
• Financial budgeting and forecasting skills
• In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes