Associate Director, Clinical Operations Management

Job Title :

Associate Director, Clinical Operations Management

Location :

San Diego, CA / Hybrid / Remote

Position type : FLSA :

FLSA : Full time

Full time

Exempt

Department : Clinical Operations

Clinical Operations

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 Twitter .

The Opportunity

The Associate Director, Clinical Operations Management (AD) supervises assigned Clinical Operations (CO) employees responsible for supporting the successful delivery of Avidity Biosciences’ clinical studies.

The AD ensures the CO team has the training, mentoring, support, and experience to meet the expectations of their role and assignments, including compliance with GCP and regulatory guidelines.

What You Will Contribute

• Ability to effectively collaborate in a highly matrixed organization.
• Contribute to and / or lead CO and Avidity process improvements, department initiatives, SOPs, forms and templates, and job descriptions.
• Assess and manage resource allocations for direct reports and CO department; support and organize candidate interview and selection process in collaboration with Avidity HR Partner.
• Provide direction and mentoring to junior team members, identify and provide training as required.
• Develop and manage the performance of CO direct reports; provide on-going feedback, development, and coaching, including mid-year and annual performance reviews, and completion of required Avidity trainings.
• Establish clear and achievable goals for direct reports, aligning with departmental and organizational objectives.
• Provide technical support and guidance (including but not limited to, scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned direct reports;

escalate to program Lead and upper management as required.

• Ensure CO direct reports work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements.
• Facilitate collaborative opportunities among peers across various programs to ensure consistency and the exchange of best practices.
• Address performance issues promptly and constructively with direct reports, providing coaching and feedback to support their professional development and team effectiveness.
• Foster a positive work culture and promote teamwork and collaboration within the CO department.
• May develop and review clinical study documents such as but not limited to Clinical Monitoring Plan, Reference Manuals, Informed Consent, CRA Tracking tools, training documents, etc.
• May contribute to or lead department meetings, participate and support Avidity corporate goals and initiatives, and attend study and / or industry meetings.

What We Seek

• Bachelor’s Degree or equivalent combination of education and experience in science or health-related field. Advanced degree preferred.
• 12+ years of industry experience in managing the clinical aspects of complex and global trials, including extensive clinical study management, financial budgeting and forecasting, line management, and experience or proven competencies for this position.
• In-depth knowledge of regulatory and compliance requirements for clinical research processes and drug development, including but not limited to, US CFR, ICH, GCP, GDP, EU / UK GDPR.
• Team leadership experience within a cross functional matrix environment.
• Demonstrated excellent presentation, communication (oral and written), teamwork, interpersonal, and critical thinking skills.
• Trial experience in Phase 1, and global Phase 2 and / or Phase 3; experience in Rare Disease or Neuromuscular drug development is a plus.
• Inspection readiness and inspection experience is required.
• 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.
• Ability to travel domestically and internationally.

What We will Provide to You :

• The base salary range for this role is $171,300 - $189,300. 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