Associate Director, Clinical Quality Assurance at Cytokinetics

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CardiovascularIndustries

Requirements

B.S degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
Current and strong working knowledge, interpretation/implementation of United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
Experience with electronic Quality Management Systems and Trial Master File
Auditor certifications a plus
Up to 10% travel may be required
Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus
Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives
Ability to use expertise and skills to contribute and achieve Cytokinetics’ company objectives

Responsibilities

Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols and Cytokinetics procedures
Accountable for inspection readiness activities including collaborating with cross functional and clinical site Inspection Readiness/Preparedness activities
Provide expert CQA advice and strategic mentorship to stakeholders (e.g. Clinical Operations, Data Management, Pharmacovigilance) to support regulatory inspections
Design and implement the creation/management/maintenance of quality plans and metrics
Collaborate with staff conducting internal and external quality audits of clinical vendors and investigator sites
Perform quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs
Coordinate and provide GCP Training for functional departments
Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance

Skills

Key technologies and capabilities for this role

GCPICH-GCPClinical AuditsInspection ReadinessPharmacovigilanceDrug SafetyBiometricsClinical OperationsQuality Assurance

Questions & Answers

Common questions about this position

What is the salary for the Associate Director, Clinical Quality Assurance position?

This information is not specified in the job description.

Is this a remote position, or is there a required location?

This information is not specified in the job description.

What skills and experience are required for this role?

The ideal candidate has a quality mindset in global clinical development, proven ability to manage multiple complex projects, and experience overseeing inspection readiness, internal and external audits.

What is the company culture like at Cytokinetics?

Cytokinetics emphasizes driving and maintaining a quality standards and regulatory compliance culture, with opportunities to enhance quality culture and have a direct impact on late and early-stage clinical trials.

What makes a strong candidate for this position?

A strong candidate has a quality mindset in global clinical development, experience leading Clinical QA activities including GCP compliance, inspection readiness, audits, and the ability to manage complex projects while advocating for quality and regulatory compliance.

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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