Avidity Biosciences, Inc.
Associate Director, Clinical Operations
Avidity Biosciences, Inc., San Diego, California, United States, 92189
Job Title:
Associate Director, Clinical OperationsLocation:
RemotePosition type:
Full timeFLSA:
ExemptDepartment:
Clinical OperationsStrive 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 works closely with the DM1 Clinical Operations Program Lead and team and is a senior clinical study leader responsible for the oversight of cross-functional clinical teams working to achieve milestones and deliverables in alignment with operational feasibility, budgets, and timelines. This role is a primary point of contact interfacing across the organization, with investigator sites, KOLs, and study vendors. The Associate Director will drive the scope of work, oversee CROs and vendors, manage risk identification and mitigation, and proactively manage patient safety and data integrity to ensure inspection readiness and compliance. This position will also be responsible for identifying tasks, priorities, and assignments for the Avidity clinical team, providing mentoring to junior clinical operations associates, and contributing to department initiatives. This position will work with Avidity clinical development, biometrics, legal, finance, regulatory affairs, medical affairs, pharmacovigilance, patient advocacy, clinical supply chain, quality assurance, and IT, as needed.What You Will Contribute
Perform clinical study development functions ensuring appropriate strategic topics are discussed and managed from study planning, implementation, and feasibility through clinical study closure and final clinical study report.Effective collaboration in a highly matrixed organization; ability to represent the clinical team during cross-functional collaboration.Represent Avidity during site meetings and visits, industry conferences, and study meetings.Report on the status of the clinical study scope of work and provide oversight and guidance to ensure key milestones are met in compliance with quality standards, including ICH, GCP, GDP, local and regional regulations, and Avidity procedures.Interface with key external stakeholders (KOLs, advocacy groups, partners, etc.) as needed to understand the therapeutic landscape.Provide operational expertise to support program level operations complementing the indication, science, and strategic intent of the program.Conduct and contribute to study meetings, provide direction, and set expectations for study vendors.Responsible for selecting study vendors and reviewing budgets and contracts for vendors and sites.What We Seek
Bachelor’s Degree required; Advanced Degree preferred.Minimum 10+ years of industry experience specific within clinical project or program management, with a comprehensive understanding of overall study management.Knowledge of global regulatory and compliance requirements for clinical research, including but not limited to CFR, ICH, GCP.Experience in developing study budgets, forecasting, managing financial oversight.Team leadership experience within a cross-functional matrix environment.Experience managing phase 3 global clinical trials (complex rare disease or neuromuscular experience preferred), including selecting and managing multiple study vendors, CROs, and clinical study teams.Proficient in creation, review, and approval of clinical study documents, including but not limited to ICFs, study manuals, forms, plans, and templates.Proven ability to maintain inspection readiness for Trial Master Files (TMFs), sites, and studies through regular audit reviews, and prompt resolution of inspection findings, and overall study management.Strong initiative, attention to detail, effective in a fast-paced work environment, proactive prioritization.Desire and ability to work within an agile and cohesive team-based structure.Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.Ability to travel globally is required, including attendance at conferences, site visits, team meetings, etc.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.
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Associate Director, Clinical OperationsLocation:
RemotePosition type:
Full timeFLSA:
ExemptDepartment:
Clinical OperationsStrive 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
and
X , formerly
Twitter .The Opportunity
The Associate Director, Clinical Operations works closely with the DM1 Clinical Operations Program Lead and team and is a senior clinical study leader responsible for the oversight of cross-functional clinical teams working to achieve milestones and deliverables in alignment with operational feasibility, budgets, and timelines. This role is a primary point of contact interfacing across the organization, with investigator sites, KOLs, and study vendors. The Associate Director will drive the scope of work, oversee CROs and vendors, manage risk identification and mitigation, and proactively manage patient safety and data integrity to ensure inspection readiness and compliance. This position will also be responsible for identifying tasks, priorities, and assignments for the Avidity clinical team, providing mentoring to junior clinical operations associates, and contributing to department initiatives. This position will work with Avidity clinical development, biometrics, legal, finance, regulatory affairs, medical affairs, pharmacovigilance, patient advocacy, clinical supply chain, quality assurance, and IT, as needed.What You Will Contribute
Perform clinical study development functions ensuring appropriate strategic topics are discussed and managed from study planning, implementation, and feasibility through clinical study closure and final clinical study report.Effective collaboration in a highly matrixed organization; ability to represent the clinical team during cross-functional collaboration.Represent Avidity during site meetings and visits, industry conferences, and study meetings.Report on the status of the clinical study scope of work and provide oversight and guidance to ensure key milestones are met in compliance with quality standards, including ICH, GCP, GDP, local and regional regulations, and Avidity procedures.Interface with key external stakeholders (KOLs, advocacy groups, partners, etc.) as needed to understand the therapeutic landscape.Provide operational expertise to support program level operations complementing the indication, science, and strategic intent of the program.Conduct and contribute to study meetings, provide direction, and set expectations for study vendors.Responsible for selecting study vendors and reviewing budgets and contracts for vendors and sites.What We Seek
Bachelor’s Degree required; Advanced Degree preferred.Minimum 10+ years of industry experience specific within clinical project or program management, with a comprehensive understanding of overall study management.Knowledge of global regulatory and compliance requirements for clinical research, including but not limited to CFR, ICH, GCP.Experience in developing study budgets, forecasting, managing financial oversight.Team leadership experience within a cross-functional matrix environment.Experience managing phase 3 global clinical trials (complex rare disease or neuromuscular experience preferred), including selecting and managing multiple study vendors, CROs, and clinical study teams.Proficient in creation, review, and approval of clinical study documents, including but not limited to ICFs, study manuals, forms, plans, and templates.Proven ability to maintain inspection readiness for Trial Master Files (TMFs), sites, and studies through regular audit reviews, and prompt resolution of inspection findings, and overall study management.Strong initiative, attention to detail, effective in a fast-paced work environment, proactive prioritization.Desire and ability to work within an agile and cohesive team-based structure.Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.Ability to travel globally is required, including attendance at conferences, site visits, team meetings, etc.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.
#J-18808-Ljbffr