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 leader in the CDM group and subject matter expert for the handling and management of laboratory and other external data types, the individual in this position will serve as the head of the External Data Solutions (EDS) team and oversee all data management activities associated with the management and transfer of data from external vendors. The duties of this role include EDS oversight including strategic resourcing, timeline planning, process improvement, data standards development and implementation, and participation in cross-functional initiatives. The responsibilities of this position also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables, creating, updating, and maintaining SOPs to ensure the validity of clinical trial databases, and being familiar with the implementation of Good Clinical Practice (GCP) and other industry standards and guidance as they apply to CDM. The individual will also provide leadership to the CDM group by leading organizational change; developing and empowering staff; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
This position is a chance to have an impact on the future of Cytokinetics and help us continue to grow! You will pair closely with biometrics, QA, CQA, Clinical Research, Clinical Operations, and Drug Safety to ensure compliance with policies, procedures, and overall clinical study and organizational objectives.
Responsibilities
- Serve as the inter-department subject matter expert for CDM – EDS for all trials 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
- Serve as a key contributor to evaluate, implement, and lead process and infrastructure development/improvement as well as staffing for EDS to build out this function to support the growing clinical pipeline. This may include external vendor management and development, systems evaluation and selection, external data integration, ad-hoc analysis, and end-to-end data standards
- Ensure all external data are in compliance with Data Transfer Specifications (DTS), standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
- Assist with implementing the corporate strategic plan within the department – planning and managing internal and external EDS resources, and assisting with managing the department budget, as required
- Provide strategic, organizational, and operational management and guidance to the personnel and teams within EDS.
- Provide technical and functional oversight of the day-to-day work and work products of EDS clinical data management staff, as needed, including clinical data collection, processing, reconciliation, and quality control procedures, timelines, and documentation
- Assist with the selection and management of data management vendors; identify potential risks and resolving issues with CROs; oversee vendor management plans and reviewing quality metrics; provides guidance and monitors the progress of DM activities with CROs or other vendors
- Contribute to identifying, locating, evaluating, and validating CDM documents, data transfer processes and infrastructure, and databases required for report generation or regulatory submission
- May assist with the coordination of non-routine projects as applicable in support of Development Operations initiatives
- Collaborate with cross functional peers to facilitate and optimize the product development and registration process
Qualifications
- Bachelor’s degree in life sciences (e.g. biology), computer, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
- At least 12 years of relevant data management experience, including at least 5 years leading the management of external data, and at least 4 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development. In lieu of 4 years of line management, at least 8 years of experience leading CDM project teams is also acceptable.
- Prior experience leading CDM infrastructure setup & deployment and CDM process improvement
- Prior experience on CRO selection and oversight as well as management experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS, 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
- In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry especially as applied to the standards and use of data from external vendors. Competence in SAS or other analytics programming tools is a plus
- Demonstrated leadership quality and superior organizational and interpersonal skills. 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.
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
