Director, Clinical Operations

Company: Avidity Biosciences, Inc.
Location: San Diego
Posted on: November 13, 2024

Job Description:

Job Title: Director, Clinical Operations
Location: San Diego, CA / Hybrid / Remote
Position type: Full time
FLSA: Exempt
Department: 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.
The Opportunity
The Director of Clinical Operations is a senior leader responsible for the strategic planning and execution of multiple clinical studies within Avidity's programs. This role involves leading cross-functional teams to define study specifications, achieve milestones, and ensure operational feasibility, including budget and timeline management. The Director acts as the primary liaison between functional groups, investigator sites, CROs, and vendors, driving the scope of work and overseeing all aspects of study execution.
Key responsibilities include proactively managing patient safety, ensuring data integrity, and maintaining inspection readiness and compliance. Additionally, the Director will lead the clinical operations department by serving as a direct line manager, implementing process improvements, and driving departmental initiatives.
What You Will Contribute

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• Lead the Clinical Operations team in the planning and execution of clinical studies, ensuring alignment with company objectives and regulatory requirements.
  
• Develop and implement clinical operations strategies that support the overall development plans of the company's therapeutic programs.
  
• Serve as a key development leadership team member, contributing to strategic decision-making and long-term planning.
  
• Oversee the design, initiation, and management of clinical trials across all phases of development.
  
• Ensure that trials are conducted on time, within budget, and in accordance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulations.
  
• Provide operational leadership and direction to cross-functional teams.
  
• Select, negotiate with, and manage relationships with CROs, vendors, and other external partners.
  
• Ensure that CROs and vendors deliver high-quality services and meet project milestones.
  
• Monitor performance metrics and conduct regular assessments of CROs and vendors to ensure compliance with contractual obligations and company standards.
  
• Maintain inspection readiness by ensuring that all clinical activities are conducted in compliance with regulatory requirements and internal SOPs.
  
• Oversee the development and implementation of quality management systems and processes within Clinical Operations.
  
• Support the preparation of regulatory submissions, including INDs, NDAs, and BLAs, by providing operational insights and documentation.
  
• Develop and manage Clinical Operations budgets, including forecasting, tracking, and reporting.
  
• Allocate resources effectively to support clinical programs and ensure the timely completion of deliverables.
  
• Identify and mitigate risks related to budget, timelines, and resources.
  
• Recruit, mentor, and manage a high-performing Clinical Operations team.
  
• Provide ongoing training and professional development opportunities to team members.
  
• Conduct performance evaluations and establish career development plans for direct reports.
  
• Act as the primary point of contact for Clinical Operations within the company, liaising with internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory authorities.
  
• Represent the company at industry conferences, meetings, and other events as needed.
  
  What We Seek
  
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  • Bachelor's Degree required; Advanced Degree preferred.
    
  • Minimum of 12 years of experience in Clinical Operations, with at least 5 years in a leadership role within a biotech or pharmaceutical company.
    
  • Extensive knowledge of clinical trial design, management, and regulatory requirements, including US CFR, ICH guidelines, and GCPs.
    
  • Proven experience in developing study budgets, forecasting, and managing financial oversight.
    
  • Experience in developing and managing study timelines.
    
  • Specialized experience in managing complex rare disease or neuromuscular clinical trials, including selecting and overseeing multiple study vendors, CROs, and clinical study teams.
    
  • Strong initiative and attention to detail, with the ability to thrive in a fast-paced environment and proactively prioritize tasks.
    
  • Ability to work effectively within an agile, cohesive team-based structure.
    
  • Demonstrated success in managing complex projects, including the selection and oversight of multiple study vendors, CROs, and clinical study teams, with a track record of delivering results on time and within budget.
    
  • Proven team leadership experience in a cross-functional matrix environment.
    
  • Excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
    
  • Willingness and ability to travel globally as required, including attendance at conferences, site visits, team meetings, etc.
    
    What We will Provide to You:
    
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    • The base salary range for this role is $208,600 - $228,200. 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.
      
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Keywords: Avidity Biosciences, Inc., Santee , Director, Clinical Operations, Executive , San Diego, California