Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. 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. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). 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 www.aviditybiosciences.com and engage with us on LinkedIn and X, formerly Twitter.

The Opportunity

The Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr. CTM) (Unblinded) supports/manages overall unblinded clinical study operations activities including contract research organizations (CROs) and other trial vendors and development of project plans. The CTM/Sr. CTM (Unblinded) will work in partnership with Clinical Supply to assist in managing the planning/forecasting, distribution, and destruction/return of clinical supplies for phase I-IV clinical trials in multi-national clinical studies. The CTM/Sr. CTM (Unblinded) will be responsible for supporting drug resupply of investigative sites and IP-related cohort management, study supply management, and will be responsible for the development and revisions of the Pharmacy Manual. This individual will successfully manage multiple projects simultaneously while adapting to changing project priorities. Instills, promotes, and maintains a culture of organizational excellence, and leads by example. They will provide support to the CRO, vendors, and sites, as well as ensure compliance with GCP and regulatory guidelines.

What You Will Contribute

• Manage CROs and vendors to execute clinical trials in accordance with contracted scope, costs, and timelines and within budget
• Provide proper oversight of study CROs and vendors by managing related activities, such as review of unblinded monitoring visit reports and follow up on issues or trends, etc.
• Develop and maintain Pharmacy Binder (Pharmacy Manual plus logs and appendices) in collaboration with Clinical Operations, Clinical Development, and CMC.
• Review study documents, such as unblinded monitoring reports, inventory logs, etc.
• Serve as an escalation point for unblinded study team members internally, CROs, and vendors
• Ensure the CRO is maintaining an inspection-ready Unblinded Trial Master File (TMF)
• Collaborate with CROs on study-specific training for study teams and study sites.
• If required, conduct co-monitoring visits with unblinded CRAs.
• Escalate pertinent unblinded CRA performance and site compliance issues when necessary
• Communicate with Clinical Supply to facilitate clinical trial drug supply at drug depot and clinical sites.  
• Monitor global clinical supply inventory (IRT and/or traditional studies) via tracking of specific milestone dates and adjusting drug distribution plan accordingly.  
• Monitor expiry dating for clinical study supplies.  Work with Avidity Clinical Supply to ensure expiry dates are updated in the IRT as IMP shelf life is extended.
• Coordinate procurement activities for ancillary supplies.  
• Serve as a resource for and interact with other functional areas to resolve clinical supply inventory, distribution, pharmacy, and site issues.
• In conjunction with Clinical Supply, identify and communicate any risks to clinical program timelines due to manufacturing/IP release delays.
• Represent the clinical function on cross functional teams
• Contribute to ongoing process improvement and department initiatives within the clinical function
• Effectively collaborate in a highly matrixed organization
• May assist with the management of Independent Data Monitoring Committees
• Provide direction and mentoring to junior team members.
• May have line management responsibilities
• Performs other duties as assigned by management

What We Seek

• 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 preferred
• Inspection readiness and inspection experience preferred
• 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
• Ability to travel if required, including attendance at conferences, site visits, team meetings, etc.

What We will Provide to You:

• The base salary range for this role is $141,900 to $156,900. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• 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.