Senior Director, Research Compliance

Kaiser Permanente•Pasadena, CA

About The Position

Job Summary: Defines overarching strategy and gains buy-in from key stakeholders and leaders to ensure implementation of updated policies, procedures, processes, and guidelines to ensure alignment and implementation across study sites, teams, departments, and regions. Spearheads organization-wide changes to processes, systems, and workflows, drives operational excellence across KP, and influences and coordinates key stakeholders and leaders to adopt operational improvements and best practices. Collaborates across the organization to implement and drive comprehensive post-approval monitoring initiatives and ensures alignment across internal and external stakeholders. Represents KP and serves as a liaison with regulatory and/or compliance agencies, accrediting bodies, and funding agencies during deliberations, audits, and conversations and documents regulatory and/or compliance decisions. Ensures alignment of short- and long-term education and training goals and objectives with overarching organizational strategy. Gains buy-in and support from key stakeholders and leaders to implement and drive education and training program improvement initiatives across local, regional, and/or national teams. Essential Responsibilities: Builds organizational capacity and prepares high potentials for growth opportunities and advancement; builds collaborative networks inside and outside the organization for self and others. Provides framework for soliciting and acting on performance feedback; drives collaboration to set goals and provide open feedback and coaching to foster performance improvement. Models and drives continuous learning and oversees the recruitment, selection, and development of talent; stays current with industry trends, benchmarks, and best practices; ensures performance management guidelines and expectations to achieve business needs. Acts as a thought leader on industry trends, benchmarks, and best practices; shares best practices within and across teams to drive improvement. Motivates and empowers teams; maintains a highly skilled and engaged workforce by aligning cross-functional resource plans with business objectives. Provides guidance when difficult decisions need to be made; creates opportunities for expanded scope of decision making and impact across teams. Oversees the operation of multiple units and/or departments by identifying member and operational needs; ensures the management of work assignment allocation and completion; translates business strategy into actionable business requirements; ensures products and/or services meet member requirements and expectations while aligning with organizational strategies. Engages strategic, cross-functional business units to champion and drive support for business plans and priorities; assumes responsibility for decision making; sets standards, measures progress, and ensures resolution of escalated issues. Sets and communicates goals and objectives; analyzes resources, costs, and forecasts and incorporates them into business plans; obtains and distributes resources. Anticipates and removes obstacles that impact performance; addresses performance gaps and implements contingency plans accordingly; ensures teams accomplish business objectives; serves as a subject-matter expert and trusted source to executive leadership; provides influence and consultation in the development of the larger organizational or business strategy. Establishes and maintains research policy by: championing a comprehensive strategy for and empowering staff and stakeholders to remain up-to-date on federal, state, and local regulations, ethical issues, and organizational policies; aligning key stakeholders and leaders on enacted and emerging changes and their implications and establishing processes to drive the adoption of broad policy updates across local, regional, and/or national teams; and defining overarching strategy and gaining buy-in from key stakeholders and leaders to ensure implementation of updated policies, procedures, processes, and guidelines across study sites, teams, departments, and regions. Supports ongoing quality monitoring and improvement by: spearheading organization-wide changes to processes, systems, and workflows, driving operational excellence across KP, and influencing and coordinating with key stakeholders and leaders to adopt operational improvements and best practices; providing strategic leadership and direction to internal and external stakeholders and leaders to devise and implement strategies that remediate complex issues within research activities; providing oversight and expertise during the creation of infrastructures and systems that support quality improvement and/or monitoring initiatives and ensuring alignment with overarching organizational strategy; and collaborating across the organization to implement and drive comprehensive post-approval monitoring initiatives and ensuring alignment across internal and external stakeholders. Drives research compliance by: representing KP and serving as a liaison with regulatory and/or compliance agencies, accrediting bodies, and funding agencies during deliberations, audits, and conversations and documenting regulatory and/or compliance decisions; ensuring thorough review and investigation of continued and complex noncompliance (e.g., protocol deviations and/or violations, reportable events, adverse events, serious adverse events, unanticipated problems); coordinating with internal and external stakeholders and leaders to drive appropriate resolution to address noncompliance; and gaining buy-in and support from internal and external stakeholders and leaders to implement and drive overarching initiatives and strategies that address and resolve findings from external investigations and/or audits findings. Facilitates the continuous education of research personnel by: ensuring alignment of short- and long-term education and training goals and objectives with overarching organizational strategy; defining and providing strategic direction on key metrics, indicators, and/or benchmarks to evaluate education and training effectiveness across local, regional, and/or national programs; and gaining buy-in and support from key stakeholders and leaders to implement and drive education and training program improvement initiatives across local, regional, and/or national teams.

Requirements

Minimum four (4) years of experience managing operational or project budgets.
Minimum five (5) years of experience in a leadership role with direct reports.
Bachelors degree in Health Science, Public Health, Law, Social/Physical/Life Science, or related field AND minimum eleven (11) years of experience in research compliance, human subjects research, research design, research operations, research data management, or a directly related field OR Minimum fourteen (14) years of experience in research compliance, human subjects research, research design, research operations, research data management, or a directly related field.
Knowledge, Skills, and Abilities (KSAs): Business Process Improvement; Risk Management; Audits; Compliance Management; Confidentiality; Health Care Compliance; Health Care Policy; Maintain Files and Records; Regulatory Reporting; Trend Analysis; Consulting; Managing Diverse Relationships; Stakeholder Management; Risk Assessment; Good Clinical Practices (GCP); Quality Assurance and Effectiveness; Research Ethics

Nice To Haves

Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS)
Certified Healthcare Compliance, Certified Healthcare Privacy Compliance, Certified Healthcare Research Compliance from the Healthcare Compliance Association (HCCA); or Certified IRB Professional.
Four (4) years of experience with project management.

Responsibilities

Builds organizational capacity and prepares high potentials for growth opportunities and advancement; builds collaborative networks inside and outside the organization for self and others.
Provides framework for soliciting and acting on performance feedback; drives collaboration to set goals and provide open feedback and coaching to foster performance improvement.
Models and drives continuous learning and oversees the recruitment, selection, and development of talent; stays current with industry trends, benchmarks, and best practices; ensures performance management guidelines and expectations to achieve business needs.
Acts as a thought leader on industry trends, benchmarks, and best practices; shares best practices within and across teams to drive improvement.
Motivates and empowers teams; maintains a highly skilled and engaged workforce by aligning cross-functional resource plans with business objectives.
Provides guidance when difficult decisions need to be made; creates opportunities for expanded scope of decision making and impact across teams.
Oversees the operation of multiple units and/or departments by identifying member and operational needs; ensures the management of work assignment allocation and completion; translates business strategy into actionable business requirements; ensures products and/or services meet member requirements and expectations while aligning with organizational strategies.
Engages strategic, cross-functional business units to champion and drive support for business plans and priorities; assumes responsibility for decision making; sets standards, measures progress, and ensures resolution of escalated issues.
Sets and communicates goals and objectives; analyzes resources, costs, and forecasts and incorporates them into business plans; obtains and distributes resources.
Anticipates and removes obstacles that impact performance; addresses performance gaps and implements contingency plans accordingly; ensures teams accomplish business objectives; serves as a subject-matter expert and trusted source to executive leadership; provides influence and consultation in the development of the larger organizational or business strategy.
Establishes and maintains research policy by: championing a comprehensive strategy for and empowering staff and stakeholders to remain up-to-date on federal, state, and local regulations, ethical issues, and organizational policies; aligning key stakeholders and leaders on enacted and emerging changes and their implications and establishing processes to drive the adoption of broad policy updates across local, regional, and/or national teams; and defining overarching strategy and gaining buy-in from key stakeholders and leaders to ensure implementation of updated policies, procedures, processes, and guidelines across study sites, teams, departments, and regions.
Supports ongoing quality monitoring and improvement by: spearheading organization-wide changes to processes, systems, and workflows, driving operational excellence across KP, and influencing and coordinating with key stakeholders and leaders to adopt operational improvements and best practices; providing strategic leadership and direction to internal and external stakeholders and leaders to devise and implement strategies that remediate complex issues within research activities; providing oversight and expertise during the creation of infrastructures and systems that support quality improvement and/or monitoring initiatives and ensuring alignment with overarching organizational strategy; and collaborating across the organization to implement and drive comprehensive post-approval monitoring initiatives and ensuring alignment across internal and external stakeholders.
Drives research compliance by: representing KP and serving as a liaison with regulatory and/or compliance agencies, accrediting bodies, and funding agencies during deliberations, audits, and conversations and documenting regulatory and/or compliance decisions; ensuring thorough review and investigation of continued and complex noncompliance (e.g., protocol deviations and/or violations, reportable events, adverse events, serious adverse events, unanticipated problems); coordinating with internal and external stakeholders and leaders to drive appropriate resolution to address noncompliance; and gaining buy-in and support from internal and external stakeholders and leaders to implement and drive overarching initiatives and strategies that address and resolve findings from external investigations and/or audits findings.
Facilitates the continuous education of research personnel by: ensuring alignment of short- and long-term education and training goals and objectives with overarching organizational strategy; defining and providing strategic direction on key metrics, indicators, and/or benchmarks to evaluate education and training effectiveness across local, regional, and/or national programs; and gaining buy-in and support from key stakeholders and leaders to implement and drive education and training program improvement initiatives across local, regional, and/or national teams.