Manager, Clinical Operations & Systems

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Job Title:

Manager, Clinical Operations & Systems
Location:

San Diego, CA / Hybrid / Remote
Position type:

Full time
FLSA:

Exempt
Department:

Clinical Operations
ID:

7525-Q224-2
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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 Manager, Clinical Operations & Systems supervises assigned Clinical Operations (CO) employees responsible for supporting the successful delivery of Avidity Biosciences' clinical studies.
The Manager, Clinical Operations & Systems 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
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 Business Partner.
Develop and manage the performance of CO direct reports; provide ongoing feedback, development, and coaching, including annual goals and objectives, mid-year and annual performance reviews, and completion of required Avidity trainings.
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 including mentoring junior team members; escalate to program Lead and upper management as required.
Address performance issues promptly and constructively with direct reports, providing coaching and feedback to support their professional development and team effectiveness.
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.
Foster a positive work culture and promote teamwork and collaboration within the CO department.
May develop and review clinical study documents such as guidance documents, templates, and work instructions.
May contribute to or lead department meetings, participate and support Avidity corporate goals and initiatives, and attend study and/or industry meetings.
Performs other duties as assigned by management, such as assisting with study start-up activities, including feasibility, investigator recruitment, and general site management support under CTM (or designee) oversight.
What We Seek
Bachelor's Degree at a minimum or equivalent.
Minimum 6 years of industry experience within clinical research or proven competencies for this position, with a minimum of 2 years of functional management experience.
Team leadership experience within a cross-functional matrix environment.
Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
Ability to travel as needed.
Demonstrates a working knowledge of ICH/GCP and clinical research processes.
Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders.
Communicates both verbally and in written form in an efficient and professional manner.
Demonstrates values and a work ethic consistent with Company Values.
Exhibits high self-motivation, is detail-oriented, and able to work and plan independently as well as in a team environment.
Ability to develop, coach and mentor CTA staff.
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient.
System Administrator experience with Trial Interactive eTMF.
What We will Provide to You:

The base salary range for this role is $147K - $163K.
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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