Associate Director of Clinical Data Management Systems and Standards

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.

We view our employees as the unequivocal ingredients to success. Every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While the expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health and lives of people with cardiovascular and neuromuscular diseases of impaired muscle function.

As the Associate Director of Clinical Data Management Systems and Standards, you will play a key role in leading and/or supporting CDM initiatives across multiple drug development programs. Your responsibilities will include developing and implementing data standards based on CDASH/SDTM, overseeing or setting up EDC databases, and managing the development of reports, listings, and dashboards within the clinical data repository or other systems. Additionally, you will support the evaluation and implementation of CDM systems and cultivate partnerships with CROs.

Leveraging your in-depth knowledge of data management platforms, clinical trial databases, and industry best practices, you will drive initiatives to enhance data quality and optimize clinical trial efficiency. Your contributions will span all aspects of clinical data management strategies, ensuring data integrity and compliance.

Responsibilities

• Serve as the inter-department subject matter expert for EDC platforms (e.g. Medidata) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
• Develop and ensure compliance from a CDM / EDC and data programming perspective including the development of SOPs and standardization of operational and technical methodologies
• Oversee CDM and data visualization programming functions. Develop the infrastructure, people, standards, and processes to build out this capability within the Cytokinetics CDM department
• Support the continued development, review and maintenance of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
• Provide technical and functional oversight of the day-to-day use of assigned CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, quality control procedures, timelines, and documentation
• Support the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools, eSAE, data lake/warehouse Clinical Data Repository solutions, and AI/machine learning
• Support the development and maintenance of the infrastructure, organization, and processes to manage and oversee EDC and other systems programming including metrics to track the quality and efficiency of build and development timelines. Assist with the selection and management of data management vendors
• Contribute to identifying, locating, evaluating, and validating CDM documents, databases, and integrations required for report generation or regulatory submission
• Assist with the coordination of non-routine projects as applicable in support of Development Operations initiatives
• Assist with leading clinical study programs as required to support company goals and objectives

Qualifications

• Bachelor’s degree in life sciences (e.g. biology), data science, computer science, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
• At least 10 years of relevant data management systems experience. Prior experience managing EDC systems (Medidata Rave preferred) trial infrastructure setup & deployment as well as leading CDM process development and improvement
• Prior experience in Clinical Data Repository including but not limited to selection, implementation and maintenance. Prior experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IWRS/RTSM, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems
• Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
• Competence in data programming (e.g. BI / analytics tools, SQL, EDC Programming) required
• Excellent written and verbal communication skills
• Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

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.

Salary Pay Range

$197,000—$241,000 USD

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