Associate Director, Clinical Data Management - External Data Solutions
Locations:
South San Francisco, California
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R100
About Cytokinetics:
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 treatments for diseases where cardiac muscle performance is compromised. The company is advancing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job Purpose:
As a leader in the Clinical Data Management (CDM) group and subject matter expert for handling laboratory and external data types, the Associate Director will head the External Data Solutions (EDS) team. This role includes strategic oversight of EDS activities such as vendor management, resource planning, process improvements, data standards development, and participation in cross-functional initiatives. The position will closely collaborate with biometrics, QA, clinical operations, and drug safety to ensure the highest quality and compliance with corporate objectives.
Responsibilities:
Functional Area:
Serve as the subject matter expert for EDS across all clinical trials, ensuring complete, high-quality clinical trial data for internal decision-making, regulatory approval, and market acceptance.
Evaluate, implement, and lead process and infrastructure improvements, including external vendor management, systems evaluation, and external data integration.
Ensure all external data complies with Data Transfer Specifications (DTS), protocols, SOPs, and overall clinical objectives.
Support development and maintenance of SOPs and process documentation per regulatory standards.
Implement the corporate strategic plan within the department, including managing resources and assisting with the department budget.
Provide technical and operational oversight of EDS clinical data management staff and activities.
Assist in vendor selection, management, and oversight, including quality metrics review and risk management.
Contribute to locating, evaluating, and validating CDM documents and databases for report generation and regulatory submission.
Coordinate non-routine projects supporting Development Operations initiatives, as needed.
Collaborate cross-functionally to optimize product development and registration processes.
Qualifications:
Education:
Bachelor’s degree in life sciences (biology, computer science, statistics, or related fields) or equivalent combination of education and relevant experience.
Graduate degree preferred but not required.
Experience:
Minimum 12 years of relevant data management experience, including at least 5 years leading external data management and 4 years of managerial experience.
Alternatively, 8 years leading CDM project teams accepted.
Experience in biotech, pharmaceutical, medical device, or CRO industries across multiple therapeutic areas and drug development phases.
Prior experience leading CDM infrastructure setup, deployment, and process improvement.
Strong background in CRO selection, oversight, and clinical data systems (EDC, eCOA, CTMS, IVRS/IXRS, reporting tools, data visualization, etc.).
Knowledge of data standards (CDISC, CDASH, SDTM) and practical experience integrating data between systems.
Competency in SAS or other analytics tools is a plus.
Skills:
Demonstrated leadership qualities, organizational and interpersonal skills.
Excellent verbal and written communication skills.
Knowledge of industry best practices, FDA and ICH regulations, GCP, and GCDMP standards.
Strong strategic thinking and problem-solving abilities.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $197,000-$240,000 per year.
Final compensation may vary based on internal equity, geographic region, job-related knowledge, skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics welcomes candidates from all backgrounds. Applicants are encouraged to apply even if they do not meet every qualification. If you are excited about what you could accomplish at Cytokinetics and believe you can add value, you are encouraged to apply.
Important Information:
Cytokinetics upholds scientific integrity, ethics, and patient-centric decision-making. All legitimate offers will come from an official Cytokinetics email domain (cytokinetics.com) after a formal interview process.
Cytokinetics does not:
Conduct interviews through non-standard text messaging applications.
Request personal financial information before an official offer.
Ask candidates to purchase equipment during hiring.
For verification or suspicious communications, contact: talentacquisition@cytokinetics.com.
For more information, visit: www.cytokinetics.com
Equal Opportunity Employer
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