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Full-Time

Senior Director

Clinical Compliance and Training

Confirmed live in the last 24 hours

Cytokinetics

Cytokinetics

201-500 employees

Develops drugs for muscle function improvement

Biotechnology
Healthcare

Compensation Overview

$261k - $319kAnnually

Senior, Expert

San Bruno, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • ICH/GCP expert with a strong understanding of FDA and EMEA regulations related to clinical development
  • BA/BS in science-related field. 15+ years’ work experience including Clinical Operations and Quality Assurance
  • Highly experienced as a Trainer, Training Facilitator or similar role
  • Advanced experience coordinating training events in a corporate setting
  • Adequate knowledge of learning management systems and web delivery tools
  • Excellent communication skills (verbal and written), including interpersonal skills with demonstrated successful team participation
  • Experience in Root Cause Analysis methodologies and CAPA management
  • Experience in supporting clinical trial GCP compliance/quality management activities and initiative
  • Strong understanding of drug development and clinical trial execution including cross functional areas involved in clinical trials
  • Experience in supporting GCP inspection readiness activities and participated in regulatory authority inspections
  • Strong leadership abilities to inspire and motivate others to achieve results
  • Strong analytical and problem-solving skills, with the ability to collect and analyze data to inform talent management decisions
  • Exceptional organizational and project management skills, with the ability to manage multiple priorities and meet deadlines
  • Ability to adapt to a fast-paced and changing environment and drive change within the organization
Responsibilities
  • Strategically lead the Clinical Compliance & Training function to deliver knowledge, training, oversight, guidance and support, to promote and maintain GCP compliance for the operation and execution of Cytokinetics clinical development programs.
  • Be the SME for Development Operations personnel for issues relating to GCP, non-compliance surveillance, Quality Events, audit/inspection responses and process optimization
  • Track quality issues, deviations, and corrective actions ensuring effectiveness and delivery
  • Partner with Development Operations personnel in Root Cause analyses and advises on content of CAPAs and audit/inspection responses
  • Drive the design, development and execution of development and training programs to support process quality and inspection readiness
  • Evaluate business unit needs to design, develop and implement annual training plans for Clinical Development departments
  • Partner with Clinical Operations, Quality Assurance, Data Management, Biostatistics, Statistical Programming, Medical Science, Drug Safety and Pharmacovigilance, and Corporate Compliance to manage study-specific training and ensure adherence to GCP compliance execution
  • Partner with Clinical Quality Assurance on remediation of quality issues related to clinical study conduct. Act as a liaison with Clinical Quality Assurance to ensure coordination and communication of quality driven initiatives, to ensure alignment on compliance decisions and recommended actions implementation

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.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

South San Francisco, California

Founded

1998

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

20%
Simplify Jobs

Simplify's Take

What believers are saying

  • Successful Phase III trial results for aficamten in treating obstructive hypertrophic cardiomyopathy (HCM) highlight the company's potential for market leadership in this area.
  • The $575M funding from Royalty Pharma ensures strong financial support for the commercial launch of aficamten and further R&D activities.
  • Recent investments and stock offerings indicate strong investor confidence and provide additional capital for growth and development.

What critics are saying

  • The late-stage biopharmaceutical market is highly competitive, with significant pressure to bring drugs to market quickly and efficiently.
  • Dependence on the success of clinical trials and regulatory approvals poses inherent risks, as any setbacks could delay commercialization and revenue generation.

What makes Cytokinetics unique

  • Cytokinetics focuses on muscle function improvement for cardiovascular and neuromuscular diseases, a niche area with high unmet medical needs.
  • The company has a robust pipeline of small molecule muscle activators and inhibitors, setting it apart from competitors with more generalized drug portfolios.
  • Strategic funding collaborations, such as the $575M deal with Royalty Pharma, provide significant financial backing for their R&D and commercialization efforts.