USA
1 day ago
Associate Director, Clinical Operations
Description

Job Title:

Associate Director, Clinical Operations

Location:

Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Clinical Operations

7525-Q224-7

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 Associate Director, Clinical Operations is a senior leader responsible for overseeing cross-functional clinical teams to achieve key milestones and deliverables while ensuring operational feasibility, adherence to budgets, and timelines. Serving as a central point of contact, this role interfaces across the organization and collaborates with investigator sites, key opinion leaders (KOLs), and study vendors. The Associate Director will define and drive the scope of work, manage CROs and vendors, identify and mitigate risks, and proactively ensure patient safety, data integrity, and inspection readiness. Additionally, this role will set priorities, assign tasks, and mentor junior clinical operations staff while contributing to departmental initiatives. The Associate Director will work collaboratively with internal teams, including clinical development, biometrics, legal, finance, regulatory affairs, medical affairs, pharmacovigilance, patient advocacy, clinical supply chain, quality assurance, and IT, to support the successful execution of clinical programs.

What You Will Contribute

Collaborate with Clinical Operations Program Leads and cross-functional teams to develop and implement study strategies aligned with corporate objectives.Manage operational aspects of clinical trials from study planning through closeout, ensuring adherence to timelines, budgets, and regulatory standards.Partner with leadership to optimize resource allocation and ensure alignment with corporate priorities.Oversee the execution of clinical studies, including investigator selection, study startup, recruitment, data collection, and closeout.Act as the clinical operations lead in cross-functional study teams, ensuring alignment and efficient communication among stakeholders.Monitor CROs, vendors, and site performance, ensuring quality deliverables and compliance with ICH-GCP and regulatory guidelines.Provide operational input into clinical study documents such as protocols, informed consent forms, and operational manuals.Contribute to vendor selection and contract negotiations, ensuring alignment with study requirements.Define key deliverables and performance metrics for vendors and CROs, regularly assessing performance to ensure accountability.Address and resolve operational challenges in collaboration with internal and external partners.Mentor and develop clinical operations staff, including Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs), to build a high-performing team.Foster a collaborative and agile team environment, promoting continuous learning and process improvement.Provide input into department-level initiatives and contribute to the development and refinement of SOPs and workflows.Identify risks and proactively implement mitigation strategies to ensure operational continuity and compliance.Maintain inspection readiness for Trial Master Files (TMFs), sites, and studies by overseeing regular audits and ensuring timely resolution of findings.Act as a key operational liaison between Clinical Operations and other departments, such as Regulatory Affairs, Biometrics, and Pharmacovigilance.Represent Avidity at investigator meetings, site visits, and industry conferences as needed.

What We Seek

Bachelor’s degree required, advanced degree preferred.Minimum of 8–10 years of experience in Clinical Operations, with at least 3 years in a leadership role.Strong experience in managing complex Phase 2/3 clinical trials, including rare disease or neuromuscular studies.Proven expertise in global trial management, CRO oversight, and vendor negotiations.Comprehensive knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.Strong leadership skills with the ability to mentor and inspire team members.Exceptional organizational and problem-solving skills with a focus on risk management.Excellent communication skills, both written and oral, with the ability to collaborate across diverse teams.Ability to manage multiple priorities in a dynamic, fast-paced environment.Demonstrates initiative, attention to detail, and the ability to adapt to change.Values collaboration and thrives in an integrated, matrixed team structure.Displays professionalism, accountability, and a commitment to excellence.Willingness and ability to travel nationally and globally as required, including attendance at conferences, site visits, team meetings, etc.What We will Provide to You:The base salary range for this role is $180,500 - $199,500. 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901

 

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