Senior Director/Executive Director, Clinical Quality Assurance
BOULDER, COPosted 30+ days ago
Job summary
Job post source
This job is directly from Edgewise Therapeutics
Job overview
The Senior Director/Executive Director, Clinical Quality Assurance at Edgewise Therapeutics leads global clinical quality assurance strategy and operations to ensure compliance and quality across clinical development programs.
Responsibilities and impact
The role involves strategic leadership of the Clinical Quality Assurance function, managing quality systems, vendor and clinical site oversight, inspection readiness, regulatory compliance, training, and budget management to support clinical trial quality and regulatory inspection success.
Compensation and benefits
The salary range is $225,000 to $275,000 depending on experience, with benefits including health insurance, discretionary bonuses, stock options, stock purchase plan, 401(k) with match, and paid time off.
Experience and skills
Candidates must have a bachelor's degree in life sciences or related field (advanced degree preferred), 15+ years in clinical quality assurance including 5+ years in senior leadership, deep knowledge of global regulatory frameworks, audit and inspection readiness experience, and strong leadership skills; quality/auditing certification preferred.
Work environment and culture
Edgewise Therapeutics values a culture of quality, operational excellence, and cross-functional collaboration focused on improving patient lives with serious muscle diseases.
Company information
Edgewise Therapeutics is a biopharmaceutical company focused on developing precision small molecule therapies for muscle diseases, with a strong leadership team and a robust clinical and pre-clinical pipeline.
Team overview
The candidate will lead the clinical quality team and collaborate with cross-functional teams including Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Medical Affairs.
Application process
Applications are accepted on an ongoing basis; Edgewise does not accept resumes from recruitment agencies and requests direct applications only.
Unique job features
This role uniquely combines strategic leadership with hands-on operational quality management and serves as the primary QA contact for global regulatory inspections, offering a high-impact position in a mission-driven biotech company.
Company overview
Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for rare muscle disorders. They generate revenue primarily through the development and commercialization of their proprietary drug candidates. Founded in 2017, the company has made significant strides in advancing its lead product, EDG-5506, which is designed to address Duchenne muscular dystrophy and Becker muscular dystrophy. Edgewise Therapeutics leverages its expertise in muscle biology and small molecule therapeutics to create impactful solutions for patients with serious muscle diseases.
How to land this job
Tailor your resume to emphasize your extensive leadership experience in clinical quality assurance, focusing on your ability to develop and implement global CQA strategies and manage cross-functional teams in a fast-paced biotech environment.
Highlight your expertise in regulatory compliance across GCP, GVP, and global health authority inspections, showcasing your skills in audit management, inspection readiness, and CAPA programs.
Apply through multiple channels including Edgewise Therapeutics' official corporate careers page and LinkedIn to maximize your application visibility and ensure you meet the ongoing application acceptance.
Connect with current Edgewise employees in Clinical Quality Assurance or related Clinical Development functions on LinkedIn, using ice breakers such as commenting on recent company achievements in muscle disease therapeutics or asking about their experience with Edgewise's clinical quality culture.
Optimize your resume for ATS by incorporating key phrases from the job description like 'clinical quality assurance,' 'inspection readiness,' 'risk management,' 'GCP/GVP compliance,' and 'vendor oversight' to improve your chances of passing automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume submissions across multiple platforms and identify relevant LinkedIn contacts, freeing up your time to prepare for interviews and deepen your industry knowledge.
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