Senior Manager

Description:

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.

Senior Manager, Externally Sponsored Research and Access Programs

In addition to Lilly-sponsored research, Lilly provides support for Externally Sponsored Research (ESR) and Access programs with provision of study drug and/or financial support.
 

• Investigator Initiated Research (IIR) is initiated, designed, and sponsored by external researchers. Lilly considers such requests for support of Investigator Initiated Research (IIR) projects based on scientific merit and strategic fit with Lilly’s areas of research interest.
• Expanded access is the provision of an investigational medicinal product (IMP) for treatment of patients with a serious or life-threatening condition who are unable or do not qualify to participate in a clinical trial and for whom no satisfactory alternative therapy is available. Expanded access is not conducted for the purpose of answering research questions. Expanded access is known by other terms in different countries, such as compassionate use, emergency use, authorization for temporary use, individual patient investigational new drug (IND), named patient use (NPU), and named patient access program.
• Externally Sponsored Collaborative Research (ESCR) may be initiated by the Sponsor or may be a collaborative effort to explore a research objective.
  
   

The Clinical Central Services function partners with the Business Units and across functional support (medical, medical affairs, legal, safety, commercial manufacturing, finance, regulatory etc.) to develop strategies for drug supplies and executes the operational activities required for contracting, planning drug supplies, and managing shipments for researchers and patients worldwide.

The Senior Manager, Externally Sponsored Research and Access Programs provides leadership, direction, and technical support for the global operations team who are responsible for Investigator Initiated Research (IIR), Expanded Access Programs (EAP), and other ESCR programs, focusing on driving efficiency to achieve operational goals and objectives. Additionally, the Senior Manager is accountable for ensuring appropriate resourcing and training to enable the supply of drug products in support of external research worldwide, including the contracting, quality documentation, planning drug supplies, and managing shipments.

Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover regional differences.

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 position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Responsibilities
 

• Manage communications/relationships and serve as the point of contact for the Cork Externally Sponsored Research (ESR) and Access Programs team, representing progress to business partners internally and externally.
• Accountable for ensuring drug shipment activities comply with local/regional requirements and Lilly quality standards.
• Accountable for prioritization of work to meet portfolio needs.
• Ensure flexibility of resources across the team.
• Provides expertise in conducting Investigator Initiated Research and Access Programs and keeping up to date with country/regional regulatory requirements.
• Develop and manage strategies to improve customer experience.
• Ensure inspection readiness through complete, accurate and readily available documentation.