Cytokinetics

Lead global clinical operations with a focus on patient safety, data integrity, and regulatory compliance, while managing vendor relationships and building high-performing teams. | Extensive experience in clinical trial management, vendor oversight, and leadership in biotech or pharmaceutical settings, with a strong understanding of global regulatory standards. | 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 Vice President, Clinical Operations provides strategic and operational leadership for the execution of Cytokinetics’ global clinical development programs. Reporting to the SVP, Development Operations, this role is accountable for delivering high-quality, compliant, and efficient clinical trials that advance Cytokinetics’ mission to improve outcomes for patients with serious muscle-related diseases. Consistent with Cytokinetics’ leadership expectations, the VP Clinical Operations leads with a strong sense of ownership, scientific rigor, integrity, and collaboration, while maintaining an unwavering focus on patients, data quality, and regulatory excellence. This role is based on-site in South San Francisco and is a key leadership presence within the Development organization. Key Responsibilities Enterprise and Patient-Focused Leadership Lead clinical operations with a patient-first mindset, ensuring participant safety, ethical conduct, and data integrity are central to all decisions. Act as an enterprise leader within Development Operations, balancing asset-level priorities with portfolio-level needs. Model accountability, transparency, and integrity in all interactions, consistent with Cytokinetics’ leadership expectations. Scientific and Operational Excellence A valued, strategic partner in the development of clinical program strategy Translate clinical development objectives into executable operational strategies that reflect Cytokinetics’ commitment to rigorous science and high-quality data. Provide operational leadership for Phase 1–3 and post-approval studies, including large, global cardiovascular trials. Ensure trials are conducted in full compliance with ICH-GCP, FDA, EMA, and other applicable global regulations. Provide strategic direction and long-range planning enabling Clinical Operations to be at the forefront of performance. Ownership and Results Orientation Own delivery of clinical trial milestones, timelines, and budgets across the development portfolio. Proactively identify operational risks and implement mitigation strategies, escalating issues with clarity and solutions. Establish and monitor performance metrics that drive accountability and continuous improvement. Collaborative “One-Team” Leadership Partner closely with senior cross-functional peers within Clinical Research, Biometrics, Regulatory Affairs, Quality Assurance (QA), Medical Affairs, CMC, Operational Excellence, Clinical Compliance and Training (CCaT) and other functions to ensure alignment and integrated execution. Foster strong cross-functional decision-making grounded in mutual respect, scientific debate, and shared goals. Represent Clinical Operations effectively in governance forums and executive discussions. Establish a consistent approach in clinical trials strategy and practices across all programs Vendor and Partner Stewardship Lead Clinical Operations CRO and vendor strategy with a focus on partnership, performance, and accountability. Ensure external partners operate to Cytokinetics’ standards for quality, compliance, and ethical conduct. Serve as Clinical Operations executive lead on strategic and partner joint-development activities Resolve escalated issues in a decisive, solution-oriented manner. People Leadership and Talent Development Build, lead, and develop a high-performing Clinical Operations organization aligned with Cytokinetics’ leadership behaviors Create an inclusive, collaborative environment that drives engagement and performance; provides opportunities for growth and development and proactively removes barriers Actively mentor senior leaders and develop succession plans to support organizational sustainability. Quality and Inspection Readiness Ensure continuous inspection readiness and strong collaboration with CCaT and QA. Lead responses to audits and inspections with rigor, transparency, and corrective action discipline. Reinforce a culture where quality is owned by the organization. Support the development and implementation of best practices, SOPs, standards, work instructions, and policies for Clinical Operations. Qualifications Education Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred. Experience 18+ years of progressive clinical operations experience in biotechnology or pharmaceuticals. Proven leadership with all phases of clinical trials; cardiovascular or rare disease experience strongly preferred. Demonstrated success leading teams in a late-stage, science-driven biotech environment. Extensive experience managing CROs and global vendors. Drug development experience in being a strategic partner for program strategy. Capabilities Aligned to Leadership Expectations Demonstrated ability to lead with integrity, accountability, and ownership. Strong scientific judgment paired with operational discipline. Ability to collaborate effectively in an onsite, fast-moving, cross-functional environment. Clear, influential communicator at the executive and Board-facing level. Work Environment and Travel This role is on-site at Cytokinetics’ headquarters in South San Francisco, CA. Domestic and international travel expected (approximately 15%). #LI-ONSITE Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $350,000 - $390,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. 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. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer 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.

Lead and manage clinical quality assurance activities, including audits, inspection readiness, and compliance monitoring for clinical trials. | 10+ years of global quality/regulatory compliance experience in pharma/biotech, with knowledge of CFR, ICH-GCP, and audit management. | 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. As the Associate Director, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and primary process owner of the CQA audit program. This role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local, ICH-GCP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to leading and conducting internal and external audits, representing CQA during inspection readiness with a proven ability to manage multiple complex projects. You will lead, execute, and manage Clinical QA activities while being an advocate to drive quality and regulatory compliance culture at Cytokinetics. This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth! Responsibilities Serve as the CQA audit program process owner and accountable for the day-to-day activities of the audit program, including audit coordinating, report reviews, response review, and CAPA follow up, and audit closures. Serve as the principal lead auditor for GCP, GVP, and GLP audits, including investigator sites, CROs, vendors, laboratories, and internal functional areas. develop, implement, and maintain a risk-based global clinical audit program, ensuring comprehensive coverage of company-sponsored trials and critical vendors. Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management. Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review. Assist with the design and the creation/management/maintenance of quality plans and metrics. Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites. Assist with quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs. Design and conduct GCP Training for functional departments, act as the primary trainer for the auditor program. Support maintenance and continuous improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics. Provide mentoring and oversight to QA staff and foster a culture of quality and accountability across clinical teams. Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance. Other CQA duties as assigned by management. Qualifications Bachelor's degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in quality audits and quality system preferred Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations Experience with electronic Quality Management Systems and Trial Master File. Auditor certification is preferred. Up to 60% travel may be required. Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus. Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives. Ability to use expertise and skills to contribute and achieve Cytokinetics’ company objectives and principles in creative and effective ways. Other duties as assigned. #LI-REMOTE Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $195,300 - $227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. 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. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer 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.