Associate Director, Clinical Compliance & Training

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.
** 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
** Required Qualifications
*** 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 Qualifications
*** Experience with learning management systems (LMS) and Veeva platforms
* Experience working in collaboration with functions including Clinical Operations, Data Management, Biostatistics, Statistical…