Associate Director, Clinical Compliance & Training

Cytokineticsis 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

• Bachelors degree in life sciences or related discipline; 810 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 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

Key Competencies

• Training program design

• Instructional effectiveness

• Attention to detail

• Cross-functional collaboration

• Continuous improvement mindset

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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer