Senior Director/ Director, Clinical Data Management

Fate’s Biometrics team is seeking a highly skilled hands-on Clinical Data Management (CDM) leader who will be responsible for leading and overseeing all CDM activities from study start-up through close-out, reporting, and archiving. This position will be responsible for developing CDM processes and standards and providing CDM expertise for cross-functional initiatives. This is a full-time, exempt position reporting to the Senior Vice President, Clinical Translation and is located at our corporate headquarters in San Diego, California. Remote candidates located in the United States may also be considered with travel expectations.
Responsibilities

• Lead and develop a highly functional CDM organization, including formulating CDM strategy, operations, infrastructure, and processes.
• Serve as the in-house CDM expert providing consultation to Clinical Science, Clinical Operations, Biometrics, Patient Safety & Safety Risk Management, and Clinical Translation; lead and/or participate in cross-functional initiatives to maintain operational excellence.
• Select and manage contract research organizations (CROs) and data management vendors; identify potential risks, resolve issues, oversee vendor management plans and review quality metrics; provide guidance, and monitor the progress of DM activities.
• Oversee data query processes by Fate, CROs and data management vendors.
• Provide input and review of clinical research documents (e.g., protocols, case report forms, and clinical monitoring plan).
• Drive the development of clinical database specifications, including eCRF design, user requirements, edit checks, query logic and data validations; oversee the EDC system build, testing, and release.
• Provide oversight for the development and quality control of data management documents including data management plans (DMPs), data validation specifications, and data transfer agreements (DTAs).
• Facilitate the development of key data and metrics reports for data cleaning and review.
• Lead the development and implementation of CDM SOPs, work instructions, standards, and best practices.
• Ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.
• Maintain/track EDC user management across programs and ensure the integrity, confidentiality, and security of all clinical data.
• Assist data management audit and address audit observations.

Qualifications

• BS/MS/PhD in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields.
• 10+ years of relevant data management experience, including a minimum of 5 years leading the management of external data.
• 5+ years of 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.
• Experience leading CDM infrastructure setup & deployment and CDM process improvements.
• Demonstrated leadership in providing strategic direction to team/project and effectively manage through unexpected events and competing priorities with internal and external partners.
• Extensive experience with effective oversight of external vendors and CROs.
• Experience in leading cross-functional initiatives and change management.
• Deep expertise in CDM and associated technologies, processes and tools, and willingness to learn, develop, and implement innovative data management methodology.
• Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is highly desired.
• Solid knowledge of the current industry best practices, FDA, and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations as related to CDM.
• 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.
• Extensive knowledge of clinical development processes from early to late-stage development.
• Exceptional interpersonal skills and problem-solving capabilities.
• Flexible, team-oriented, and results driven.
• Excellent oral and written communication and presentation skills.
• Oncology clinical trial experience strongly preferred.
• Experience using Metadata Rave strongly preferred.

Working conditions and physical requirements

• Travel may be required (up to 25%)
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Work is typically performed in an office environment, however there is consideration for a potentially mixed virtual/office situation. Onsite work at corporate headquarters in San Diego, CA  

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
• The anticipated salary range for this role is $200,000 - $250,000

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.