Associate Director, Pharmacoepidemiology Study Operations

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Purpose:

Global Patient Safety (GPS) is responsible for the management of safety information in support of Lilly marketed products and for compounds in development. Risk management is a continuous process of assessing a product's risk and taking appropriate steps to optimize and maintain a positive benefit-risk balance of the product for patients.  Post-authorization safety studies are often conducted in order to further assess adverse events of interest which may impact a positive benefit-risk balance for a given product. The Associate Director Pharmacoepidemiology Study Operations (AD Ops)is responsible for providing operational support in the design and implementation of pharmacoepidemiology studies.   The AD Ops will also support the development and maintenance of consistent operational processes for completing this work and other related PE project work.

The primary purpose of the AD Ops is to support the planning, contracting, execution and tracking of complex pharmacoepidemiology studies through the application of project management and expert knowledge in PE studies.  This includes supporting teams on the delivery of cross-functional initiatives and projects; accountability for delivery of project milestones through the utilization and development of project management tools, processes and standards; developing risk analysis, implementation and contingency plans at the project level; influencing operational best practices across the pharmacoepidemiology department; building and maintaining effective relationships with the pharmacoepi team as well as partners involved in pharmacoepidemiology studies & other projects; effectively managing upward and cross-functional communications; and ensuring documentation of key team information and decisions.  In addition, the AD Ops will work with Subject Matter Experts (SMEs) within GPS and and non-GPS functions on department projects as appropriate.

• Establish regular communication with key GPS, regulatory, business unit (BU) and affiliate personnel as appropriate for specific studies

• Provide operational consultation resources, tools, and expertise as needed to support specific studies

• Liaise between PE scientists and Research and Development Operations (RD Ops) /Procurement/ Quality in the contracting of PE studies to external vendors to ensure cross-functional communication and overall coordination in the development of RFPs, identification of TPOs, creation of resourcing requests, and advising on scope of work for determining quality assessment requirements.

• Assess operational feasibility for planned PE studies, ensuring that privacy, local laws, affiliate requirements, logistical requirements and other operational elements are considered.

• Coordinate the development of communication plans for teams as needed.

• Influence complex business or technical issues in the management of resources necessary to ensure study success

• Anticipate and resolve key technical and operational problems and coordinate change management for studies and deliverables; this will require tactical understanding of all Safety Quality System & Medical Quality System requirements applicable to the GPS PE to ensure study execution is in compliance with all internal requirements.

• Adapt plans and implement appropriate changes in response to rapidly changing requirements and environment.

• Coordinate and facilitate the functioning of PE studies in collaboration with product specific Project Management, as required which would include tracking of study milestones.

• Monitor the implementation and execution of PE studies in conjunction with the BU CTM and GPS quality group and execute interventions necessary to ensure attainment of milestones and deliverables; this would include applicable internal documentation of appropriate GPS oversight.

• Coordinate and/or facilitate team review meetings and after-action reviews­ both internal as well as with regulatory agencies (in conjunction with regulatory scientists) to identify process issues and strengths.

  Lead for department-specific operational tasks & projects

• Drive solutions leading to consistency in tracking, documenting and communicating project metrics.

Identify, communicate and manage the critical path and leading indicators of team progress and major milestones across multiple products.

Influence resource prioritization decisions across portfolio as well as vendor selection decisions.

Work closely with PE Sr Director and/or delegates to identify operational gaps & drive solutions department-wide.

Build relationships with internal cross-functional customers and external TPOs involved in implementation on PE projects.

Minimum Qualification Requirements:

Bachelor's degree in a science-related field with 5 years of experience with cross functional project management, drug development or a related field in the pharmaceutical industry.

Other Information/Additional Preferences:

Experience in Pharmacovigilance and patient safety

Experience with implementation of observational studies

Proficiency in MS Teams and document management systems

Applied knowledge of project management tools and processes (e.g. management of integration of scope, time, cost, quality, human resources, communications, risk and procurement)

Demonstrated proficiency with MS Word, Excel and PowerPoint

Demonstrated excellent oral and written communication skills with the ability to communicate clearly and concisely to stakeholders and team members

Demonstrated excellent problem-solving skills with the ability to recognize problems and take corrective action

Demonstrated excellent teamwork skills with the ability to adapt to and influence diverse interpersonal styles; ability to influence and negotiate; ability to work in a rapidly changing environment

Demonstrated strong judgement, decision-making, and ability to work through ambiguity

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