Senior Director, Epidemiology Operations

Job Description

Responsible for the leadership and oversight of the clinical operations teams across the portfolio of Epidemiology studies supporting the end to end (study start up through publication/study close out) coordination and execution of observational or non-interventional research studies (including Post Authorization studies) in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Leads and directs team members in key study planning, development, and execution elements closely monitoring performance against objectives, quality and timelines throughout the study life-cycle. This individual will lead development and tracking of organizational KPI’s (Key Performance Indicators), provide high level performance and operational data for NIS work for the department. Collaborate with the Biostatistics and Research Decision Sciences.

Epidemiology Leadership Team in strategic planning, scientific and operational alignment, and prioritization for and delivery of portfolio goals and objectives. Responsible for facilitating and collaborating with key internal/external stakeholders in support of Epidemiology portfolio objectives. Provides oversight and guidance in managing partners and/or vendors. Builds talent and capabilities of team members through proactive coaching, mentoring and development opportunities. Establishes strategy and provides leadership and direction of initiatives which increase organizational capabilities and or support operational efficiencies. Includes management of direct reports including assignment of resources, professional development, and performance management.

Primary responsibilities for the role include:

• Demonstrated leadership in managing teams of people, research development programs and processes, leading meetings and influencing peers and direct/indirect reports in a matrixed environment. Ability to build, mentor and develop talent throughout the organization.
• Manages and provides feedback and developmental opportunities for direct reports.
• Advanced analytical skills to drive operational planning and execution.
• Strong strategic thinking capabilities, leads creation of organizational vision and empowers teams for success.
• Leads process/business improvement initiatives in collaboration with key stakeholders. Proactively identifies any gaps in current processes and or identifies areas for improvement.
• Manages a team of operational therapeutic area leaders and study managers (R2-R5) for non-interventional research, including leading/coordinating the recruitment, interviewing, hiring, training and on-boarding & coaching of new personnel.
• Leads the development of standard reporting deliverables for assigned TA(s) which support the development of performance metrics and KPI’s and assist to drive strategy for the execution of non-interventional studies (NIS), as well as resource planning/allocation.
• Provides updates and metrics for portfolio of Epidemiology studies for sharing with Biostatistics and Research Decision Sciences Epidemiology leadership, including highlighting any risks, delays and mitigation plans.
• Leader of the Global Clinical Trial Operations Epidemiology …