Job 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. Job Summary** The Sr Director, Clinical Delivery Capabilities (CDC) – Process, Systems & Strategic Integration serves as the senior operational and strategic leader accountable for the end-to-end process and systems architecture applied by Exploratory Medicine and Pharmacology (EMP). The EMP processes and architecture connect internally with process and systems in the broader Clinical Design, Delivery & Analytics (CDDA) organization and externally with vendor/TPO partners. This role ensures that Exploratory Medicine and Pharmacology (EMP) can deliver its clinical portfolio compliantly and efficiently through external vendors and CRO partners, while remaining aligned to Lilly's internal quality and regulatory frameworks. This role makes independent technical and business judgments that shape how EMP's process and compliance architecture evolves, influencing decisions across CTF, Quality, Compliance, IDS, Business Development, and external partners to position EMP for portfolio delivery. The Snr Dr PSSi has three main areas of accountability. First, the Snr Dr PSSi acts as the primary process and systems connection point between CDC and CTF, ensuring EMP-specific delivery processes are integrated into and enterprise-level clinical trial standards. Second, it enables outsourcing by designing the process frameworks and compliance architecture that allow EMP to deliver clinical work through third-party partners while maintaining internal compliance. Third, it leads the strategic integration of acquisitions and in-licensed programs into EMP, owning the governance of how work, systems, and people are transferred into the function. Job Responsibilities** Process & Systems Integration Lead EMP's representation in cross-functional process governance bodies, communicating on process performance, compliance posture, and change initiatives Maintain an integrated view of process interdependencies between CDC and CTF, including data standards, system connectivity (Vault Clinical, CT Registry, eTMF), and role accountability at critical decision points Identify and drive automation and innovation as new systems and technologies are adopted, ensuring EMP's operational needs are reflected in enterprise design decisions Monitor EMP delivery experience and execution, proactively surfacing process friction to CTF process owners for inclusion in the improvement cycle Ensure EMP's clinical delivery processes remain fully aligned with ICH guidelines, regulatory requirements, and internal quality standards, partnering with Quality, Medical Compliance, Legal, and IDS as needed Compliant Outsourcing Process Design Own the process architecture that enables EMP to deliver clinical studies through CRO and TPO partners in full compliance with Lilly's quality systems and regulatory obligations Design and maintain standard process frameworks, templates, and capability requirements that translate Lilly's internal standards into vendor-executable results Define and maintain role accountability and decision rights at key Lilly–vendor handoff points, ensuring unambiguous process ownership across the outsourced delivery model Partner with CTF, Quality, and Compliance to ensure EMP's outsourced model is reflected in enterprise process design and quality system documentation Review the evolving regulatory landscape (FDA, EMA) on outsourcing and oversight obligations, proactively shaping EMP's process framework ahead of compliance risk Serve as EMP's primary point of accountability for inspection readiness relating to externally-delivered activities; lead responses to audit and inspection findings on outsourced work Acquisition & Program Integration Own EMP's strategic integration framework for acquisitions, licensing deals, and program transfers, defining the approach for transitioning work, systems, data, and teams into the EMP operating model Lead cross-functional integration workstreams in Business Development, HR, IDS, Quality, and functional leaders Establish a standardised integration methodology covering process adoption, system migration, data transfer, quality and capability development Act as change leader through acquisition