Executive Director, Data Management

The Executive Director, Data Management will be accountable for overseeing and ensuring consistent implementation of the data management activities for SMP Oncology’s clinical development portfolio. In collaboration with VP, Head of Data Management, this role will be key in driving efficiency in Data Management and Clinical Operations activities through review and implementation of increased functionality of the department systems and technology. This role is both operational and strategic working within department as well as cross-functionally with goal of driving risk-based approach to activities. The role will be responsible for resourcing and training the department.


  • Provide clinical data management oversight of outsourced clinical trials for phase I-IV studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
  • Lead efforts to develop internal expertise in order to increase internal DM activities across all studies.
  • Introduce risk-based quality management and develop plan for implementation across programs. Coordinate with other functions as applicable.
  • Act as primary liaison with CROs, third party data vendors, and EDC vendors
  • Participate in vendor governance meetings and collaborate with Clinical Business Operations in creating outsourcing
  • Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.
  • Primary reviewer for eCRFs, eCCGs, and Data Management Plans.
  • Oversee database design and production, ensuring that the CRO/vendor meets the highest quality following SMPO standards
  • Oversee report specification development as well as plan for programming across studies for patient profiles, QC listings and study oversight.
  • Accountable for external data vendor documentation, management, and reconciliation.
  • Management, training and mentoring responsibilities for internal data management team members.
  • Key contributor to the strategic oversight of clinical programs and individual SMP Oncology sponsored trials.
  • Facilitate departmental process improvement and integration of technology.
  • Perform other duties as assigned.


  • Highly developed mastery of complex clinical trial design issues in all phases of clinical development with a minimum of 10 years increasing responsible experience in clinical trial management, as well as LEAD clinical data management experience.
  • Thorough working knowledge and understanding of Good Clinical Practices and ICH Guidelines and other applicable international regulations.
  • Knowledge of Risk Based Quality Management across clinical trial
  • Participate in NDA as key contributor for Data Management organization
  • Lead an organization as key contributor through both FDA and EMA inspection
  • Record of successfully completed clinical trials in all phases and multiple therapeutic areas as well as extensive CRO oversight.
  • Ability to provide motivational leadership to the organization and improve its performance through the adoption of novel approaches to data management’s collaboration with other functions
  • Demonstrated proficiency managing the lifecycle of clinical data projects.
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
  • Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
  • Ability to see ahead clearly and anticipate future consequences and trends accurately.
  • Demonstrated track record of leading by example and leading others in problem solving and finding creative solutions based on sound judgment.
  • Strong track record of attracting and developing data management, serving as a visible and engaging leader.

The base salary hiring range for this position is expected to be $227,300 to $307,200 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time and our tuition reimbursement program.

Job Location: Remote

Equal Opportunity Employer

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