Job Title:
Director, Clinical Operations (Unblinded)
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Clinical Operations
7525-Q224-14
Profoundly Improve People's lives by Revolutionizing the Delivery of RNA Therapeutics
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 and engage with us on LinkedIn and X .
The Opportunity
The Director, Clinical Operations (Unblinded) is a senior leader responsible for overseeing unblinded activities across multiple clinical studies within Avidity's programs. This role provides strategic leadership, mentorship, and operational oversight to drive excellence in clinical trial execution while ensuring compliance with GCP and regulatory guidelines. The Director plays a key role in shaping and advancing Clinical Operations (CO) strategies, process improvements, and organizational development. This role requires close collaboration with CO, CMC, Supply Chain, and external vendors to ensure the delivery of complex, global studies.
Additionally, this position is responsible for line management, providing training, support, and mentoring for direct reports to ensure their professional growth and successful execution of assigned responsibilities.
What You Will Contribute
- Lead the unblinded Clinical Operations team in the planning and execution of clinical studies, ensuring alignment with company objectives and regulatory requirements.
- Oversee study execution in collaboration with CROs and vendors, ensuring adherence to scope, timelines, budget, and quality standards.
- Provide proper oversight of study CROs and vendors by reviewing unblinded monitoring visit reports, identifying and addressing issues and trends, and ensuring timely resolution.
- Develop, review, and/or consult on reports and clinical trial documents such as informed consent, clinical protocols, clinical monitoring plans, 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 (uTMF).
- Collaborate with CROs on study-specific training for study teams and study sites.
- Conduct co-monitoring visits with unblinded CRAs (uCRAs), as required.
- Facilitate and support unblinded Sponsor oversight visits, as required.
- In conjunction with CMC, support planning and forecasting for study protocols
- In conjunction with Supply Chain, develop request-for-proposals documents and solicit and evaluate bids; lead contracting process with selected vendors, collaborating with relevant departments such as Legal and Finance.
- Collaborate with Clinical Operations, Clinical Development, and CMC to support the development and maintenance of the Pharmacy Binder (Pharmacy Manual plus logs and appendices).
- Support Clinical Supply in proofing, and translation of clinical study labels, as required.
- Work closely with CMC and attend CMC meetings, as necessary, to ensure full collaboration and seamless communication regarding drug supply, expiry, labeling, timelines, etc.
- Communicate with CMC to facilitate clinical trial drug supply at drug depot(s) and clinical sites.
- Monitor global clinical supply inventory (IRT and/or traditional studies) via tracking of specific milestone dates and adjusting drug distribution plans accordingly.
- Monitor expiry dating for clinical study supplies and work with Supply Chain to ensure expiry dates are updated in the IRT as IMP shelf life is extended.
- Coordinate procurement activities for pharmacy ancillary supplies, as required.
- Serve as a resource for and interact with other functional areas to resolve clinical supply inventory, distribution, pharmacy, and site issues.
- In conjunction with CMC, identify and communicate any risks to clinical program timelines due to manufacturing delays.
- Represent the unblinded 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 oversee management of Independent Data Monitoring Committees
- 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 unblinded 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 unblinded 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
- Bachelor's Degree required; Advanced Degree preferred.
- Minimum of 12 years of experience in Clinical Operations, with at least 8 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.
- Proven track record of managing unblinded study tasks and teams, including oversight of investigational product handling, drug accountability, and pharmacy operations.
- Demonstrated experience collaborating with Clinical Supply and CMC teams to support packaging, labeling, distribution, and expiry management activities.
- Strong background in vendor selection and oversight, with specific experience managing CROs, IRT vendors, and other third-party providers.
- Technical proficiency with clinical systems, particularly IRT platforms, as well as familiarity with CTMS, TMF, and document tracking tools.
- Specialized experience in managing complex rare disease, neuromuscular or cardiac clinical trials
- 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
The base salary range for this role is $218,500 - $241,500. 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 include 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
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