Senior Director, National Human Research Protection Office

Job Summary:

This senior director level position is primarily responsible for overseeing company compliance activities including designing strategies for the implementation of regulatory changes. Responsibilities include directing compliance reporting efforts, compliance investigation, and activities associated with continued regulatory compliance across multiple business functions. Additional key responsibilities include directing and overseeing the implementation of compliance efforts through approving requirements and monitoring ongoing compliance adherence. This managing level employee also directs programs or compliance components of larger cross-functional programs including identifying and managing stakeholders.

Essential Responsibilities:

·Leads the KP Human Research Protection Program (HRPP) Office which promotes a culture of compliance and learning, focuses on protecting the welfare and rights of human research participants, and facilitates excellence in the conduct of human research.  In collaboration with IRB leaders, evaluates, implements, and manages IRB support systems and processes, quality assessment and monitoring programs, and research education and training programs that are consistent with extensive and complex Federal, State and local regulations.  Assesses current policies and procedures and develops new policies and procedures as needed to ensure up-to-date regulatory compliance and research integrity. 

·Models and drives continuous learning and maintains a highly skilled and engaged workforce by aligning cross-functional resource plans with business objectives; overseeing the recruitment, selection, and development of talent; motivating and empowering teams; building organizational capacity and grooming high potentials for growth opportunities and advancement; staying current with industry trends, benchmarks, and best practices; providing guidance and leadership when difficult decisions need to be made; and ensuring performance management guidelines and expectations drive business needs.

·Oversees the operation of multiple units and departments by identifying customer and operational needs; analyzing resources, costs, and forecasts and incorporating them into business plans; engaging strategic, cross-functional business units to champion and drive support for business plans and priorities; translating business strategy into actionable business requirements; obtaining and distributing resources; setting standards and measuring progress; anticipating and removing obstacles that impact performance; addressing performance gaps and implementing contingency plans accordingly; ensuring products and/or services meet customer requirements and expectations while aligning with organizational strategies; serving as a subject-matter expert and trusted source to executive leadership; and providing influence and consultation in the development of the larger organizational or business strategy.

·Oversees company compliance activities by ensuring team members, including external business partners, provide support to internal and external stakeholders; reviewing and approving compliance activities; designing strategies for the implementation of regulations and regulatory changes; ensuring compliance activities are fully documented; and overseeing the resolution of compliance issues.

·Directs compliance reporting efforts across multiple business functions by overseeing the evaluation and summary of compliance data, audit information, and potential risks and remedies; identifying and reporting key compliance drivers, liabilities, and performance indicators (for example, adherence to standards, incorporation of new regulations) to senior management; and developing complex presentations to convey key findings to executive leadership and external business stakeholders.

·Directs compliance investigations across multiple business functions by overseeing the collection and analysis of quantitative and qualitative data; conducting interviews on escalated issues as appropriate; reviewing and evaluating research on key business issues; and evaluating and recommending corrective action plans for substantiated allegations.

·Directs programs or compliance components of larger cross-functional programs by identifying and managing stakeholder contacts; assembling teams based on program needs and team member strengths; developing, analyzing, and managing program plans; negotiating and managing program schedules and resource forecasts; and managing program financials and deliverables.

·Directs activities associated with continued regulatory compliance for multiple business functions by monitoring, interpreting, and designing strategy around regulatory changes; determining the impact of changes to the business; providing direction on implementation of changes throughout the business; and providing regulatory input before and during inspections to minimize the risks of future non-compliance.

·Directs and oversees the implementation of compliance efforts by approving compliance requirements; ensuring the assessment of current state compliance to identify gaps and corrective actions; overseeing the analysis and development of complex compliance standards, policies and procedures, and training; and ensuring the monitoring of ongoing compliance adherence.