Cytokinetics · 3 days ago
Associate Director, Clinical Compliance & Training
San Francisco Bay Area
Full-time
Hybrid
Lead/Staff, Director/Executive
$196K/yr - $229K/yr
8+ years expCytokinetics is a specialty cardiovascular biopharmaceutical company focused on advancing new medicines for patients with cardiac muscle dysfunction. The Associate Director, Clinical Compliance & Training will design and oversee the clinical training strategy, ensuring compliance with Good Clinical Practice regulations and supporting continuous improvement initiatives within clinical development activities.
BiopharmaBiotechnologyHealth Care
Responsibilities
Develop, maintain, and execute a comprehensive clinical development training program that supplements Quality Assurance-administered GCP and Controlled Document training
Annual GCP Training Plan – drive the process for annual training plan strategy, development, review, approval, and execution
Role-based Competency Training – develop/maintain a role-based competency program that sets up Cytokinetics personnel for success in their roles and supports personnel growth and development
Onboarding – develop/maintain a modular onboarding program for new personnel that incorporates role-based training; conduct Development Operations new hire orientation
Study-specific Training – serve as Veeva Study Training business process owner
Training Curriculum – collaborate with Quality Assurance/Functional Area Management to ensure GCP/study training curricula are role-based and fit-for-purpose per ICH GCP E6(R3)
General Training Support – manage training request intake, assessment, planning, and delivery; develop, coordinate, schedule, and/or deliver training as needed; ensure proper training documentation for trainings administered
Training Needs Assessment – conduct department-wide assessment and identify skills or knowledge gaps that need to be addressed; incorporate into annual training plan or other continuous improvement activity as appropriate
Effectiveness checks – evaluate training effectiveness and continuously improve training content and delivery methods
Maintain CCAT Sharepoint/equivalent intranet site
Study-specific Training – conduct/oversee study-specific training compliance checks, reporting, and follow-up
Key performance indicators (KPIs) – training KPI development, monitoring, and reporting
Inspection Readiness – support by ensuring training documentation is accurate, complete, and inspection-ready
Partner with Clinical Compliance and Functional Area Management to address training-related observations, quality events, and CAPAs
Support training requirements/review for clinical trial service providers
Manage/mentor/oversee Training personnel
Other CCAT activities as assigned
Qualification
Required
Bachelor's degree in life sciences or related discipline; 8–10+ years of experience in clinical research, clinical training, or clinical quality within pharma, biotech, or CRO
Strong knowledge of ICH-GCP and clinical trial conduct
Experience developing and managing clinical training programs
Experience supporting GCP regulatory inspections or audits
Preferred
Experience with learning management systems (LMS) and Veeva platforms
Experience working in collaboration with functions including Clinical Operations, Data Management, Biostatistics, Statistical Programming, Clinical Systems, Clinical Research, Clinical Supplies, Drug Safety and Pharmacovigilance, Regulatory Affairs, Medical Affairs, Information Technology, Human Resources, and Corporate Compliance, as needed, to develop and implement clinical training programs
Global Phase 1 through Phase 4 clinical trial experience
Experience as a Trainer, Training Facilitator, or similar role
Company
Cytokinetics
Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.41BKey Investors
Royalty PharmaDeerfieldVulcan
2025-09-16Post Ipo Debt· $650M
2024-05-22Post Ipo Equity· $550M
2024-05-22Post Ipo Debt· $50M
Leadership Team
Robert Blum
President & CEO
Sung Lee
EVP & CFO
Recent News
GlobeNewswire
2026-01-13
Company data provided by crunchbase