Sr. Director - GPS Case Management Clinical & Commercial Liaison

Location: Indianapolis

Sr. Director - GPS Case Management Clinical & Commercial Liaison page is loaded## Sr. Director - GPS Case Management Clinical & Commercial Liaison locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Yesterday job requisition :
R-101810

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.
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* Purpose:

** The purpose of the Sr. Director - Global Patient Safety Clinical and Commercial Liaison is accountable for development of Case Management strategy and standards for safety-related organized data collection in Lilly clinical trials and commercial activities (e.g., patient support programs and market research) in compliance with global regulatory requirements and Lilly compliance policies and standards. This role oversees the Case Management Operations safety data collection strategy across clinical trial and commercial programs and engage in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Lilly products.

This role ensures effective collaboration between Global Patient Safety (GPS) and clinical development teams, commercial operations, call centers, market research programs, and patient support initiatives working in close collaboration with internal GPS leaders responsible as well as commercial and clinical functional leaders and external business partners. This role reports to the Associate Vice President / Vice President of Case Management.
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* Primary Responsibilities:

** This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.
** 1.
**** Departmental Leadership
*** Develop and implement strategic plans for standardization of adverse event collection across all clinical trials and commercial programs, ensuring consistent pharmacovigilance data standards and appropriate scientific expertise aligned to current and future product portfolios.
* Lead initiatives to standardize AE collection procedures, innovate technology for improved data capture and quality, and benchmark against industry standards.
* Collaborate cross-functionally with the Clinical Development and Commercial Teams,  Case Management Operations, GPS Medical Review, Safety Science, Regulatory Affairs, Legal, Compliance, and Tech@Lilly/PV Data and Systems to ensure seamless AE handoff, address safety concerns, optimize systems, and align on regulatory and contractual requirements.
* Advance concerns arising from clinical trials, developmental programs, and commercial programs in accordance with SOPs; contribute to drug safety documents including SAE reporting plans, IND/EU annual reports, and periodic reports as needed.
* Support business planning for new product launches, internal and external inspections, and GPS Case Management strategic planning—representing Clinical & Commercial Liaison capabilities and resource needs.
* Identify resource requirements and handle budget for liaison activities and external training programs.
* Support internal and external regulatory inspections and audits through direct involvement, resource coordination, document preparation, and subject matter expertise.
** 2.
**** Enterprise Leadership
*** Responsible for developing strong cross functional relationships to ensure and promote compliance with data collection standards, analysis, reporting standards and operational consistency across interventional, non-interventional trials and commercial programs for all Lilly products.
* Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
* Responsible for development of strong cross functional relationships to ensure and promote compliance with data collection, analysis, reporting standards and operational consistency across interventional, non-interventional trials and commercial programs for all Lilly products.
* Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
* Ensures preparation of the safety contents for regulatory requests, Data Monitoring Committees reports and…