Sr. Director - Externally Sponsored Research and Access Programs

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$151,500 - $222,200

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Main Purpose and Objectives of Position:

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 (Quality, medical, medical affairs, legal, safety, CT supply planning, 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 Sr. Director, Externally Sponsored Research and Access Programs is accountable for partnering with drug development teams, Global Regulatory Affairs (GRA), Clinical, CM&C, and the broader Product Delivery (PD) Organization to develop supply strategy for clinical drug supplies provided to support Investigator Initiated Research (IIR) and Externally Sponsored Collaborative Research (ESCR) across the Lilly portfolio. 

The Sr. Director provides strategic leadership, technical and regulatory expertise in all aspects of supplying Lilly drug products for non-Lilly sponsored clinical trials (CTs). They are accountable for influencing the regulatory filing strategy, and the supply strategy sourcing/vendor strategy for supplying Lilly drug products in alignment with global regulations.

Responsibilities:

 Drug Supply and Regulatory Strategy

• Develop and implement drug supply strategies for supported molecules to ensure:
  • Plans are robust with key risks identified and mitigated.
  • Plans are integrated and communicated across the supply chain (includes GRA, packaging, distribution, and clinical teams)
  • Supply chain principles are leveraged.

• Understand current GMP/GDP/GCP regulations impacting the provision of drug products to health care providers and patients, as well as external benchmarking/networking information, to optimize support being provided and increase value to projects/portfolio.
• Ensure establishment of a supply strategy to support the clinical plan that aligns with sponsors’ protocol language and regulatory filing strategy.
• Partner with the asset teams and commercial supply chain to develop and communicate demand forecast and cost considerations as an input into decision making, ensure annual business plan forecast is accurate, monitor forecast to plan and communicate changes, risks, and impact appropriately.
• Deliver the supply strategy for supported molecules:
• Manage and