Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job purpose
The Senior Director, Clinical Compliance & Training will provide GCP/ICH quality leadership and strategic development of quality initiatives, supporting a quality culture in the execution of Cytokinetics clinical development programs. This person will provide guidance and support for Development Operations including oversight of clinical quality activities and ensure clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals.
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
Qualifications
- 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
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
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 our General Data Protection Regulation (GDPR) policy PRIOR 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.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer