Associate Director, Clinical Compliance & Training

Cytokinetics•South San Francisco, CA

1d•Hybrid

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Associate Director, Clinical Compliance & Training (CCAT) – Training Lead will be responsible for designing, implementing, and overseeing the clinical training strategy supporting early-stage, late-stage, and Phase 4 clinical programs. This role will partner with Quality Assurance and Functional Area Management to ensure that Cytokinetics clinical development personnel are appropriately trained on Good Clinical Practice (GCP) regulations and guidelines, Standard Operating Procedures (SOPs), and role-based processes. While primarily focused on training, this role will also support broader CCAT initiatives, including inspection readiness and continuous improvement efforts to meet GCP expectations, reinforce quality culture, and ensure quality and compliance of Cytokinetics clinical development activities.

Requirements

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
Training program design
Instructional effectiveness
Attention to detail
Cross-functional collaboration
Continuous improvement mindset

Nice To Haves

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

Responsibilities

Develop, maintain, and execute a comprehensive clinical development training program that supplements Quality Assurance-administered GCP and Controlled Document training. This includes:
Training Operations
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
Training Compliance
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
General
Manage/mentor/oversee Training personnel
Other CCAT activities as assigned