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.
This role will report to the VP, Biometrics and be accountable for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP., This role manages the CDM function, ensuring the development and readiness of personnel to deliver on existing programs while also being forward-looking and innovative.
Responsibilities
- Provide a high level of expertise and guidance in data management to support clinical studies
- Promote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency
- Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH
- Prepare budget forecast and management of CDM budgets, timelines and resources
- Provide guidance and inputs in the development of key control documents (e.g., data management plans and related documents)
- Lead systematic professional development and provide strong support for direct reports and other members of the CDM department
- Provide leadership and functional mentorship for internal data management staff
- Provide leadership and direction for outsourced activities including quality control and budget
- Oversee all assigned clinical trials to ensure data quality, integrity and timeliness
- Partner closely with the Study Management Team to set study goals and objectives
- Lead and coordinate evaluation, qualification and selection of vendor technology including data visualization tools (i.e. Spotfire), innovative CDM technologies, and advocate data quality
- Conduct budget assessment, contract negotiations, training and oversight for all DM outsourced services from study start-up through study close-out and final reporting
- Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget.
- Creates and maintains positive, cohesive work environment.
Qualifications
- Bachelor’s Degree with 12+ years’ experience in Clinical Data Management at a CRO, biotechnology, or pharmaceutical company; and minimum of 8 years’ prior management experience
- Must have expert knowledge of good data management practices in global clinical trials
- Thorough knowledge of applicable regulatory rules and guidelines
- Complex and/or international trials experience
- Demonstrated proficiency in the data management processes
- Possesses excellent interpersonal communication skills (written and verbal)
- Strong attention to detail
- CDSIC expertise
- Proficient in the use of the clinical data management systems (e.g. Medidata Rave)
- Possesses a positive attitude and works well with others
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.
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$270,000—$330,000 USDOur 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
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