Process, Systems and Strategic Integration, Executive/Snr Director, Clinical Delivery Capabilities (EMP)

Job Responsibilities

• 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
• Define 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
• Potentially 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 transitions, assessing impact, developing communication strategies, and embedding innovation
• Identify and handle integration risk, establishing achievements, decision gates, and critical issue paths; contribute to post-integration reviews to an innovative approach
• Study Development & Execution Support
• Lead and support concerns, external partnership operations, and vendor and CRU assessments as appropriate
• Maintain awareness of regulatory trends relevant to the assigned portfolio and apply innovation and lessons learned in real time
• People Leadership & Continuous Improvement
• Attract, retain, and develop a diverse, high-performing team with sufficient expertise to sustain service delivery
• Foster a culture of continuous kaizen, driving efficiency, innovation, and acceleration across the portfolio
• Model high-performance behaviours and create an environment where individuals are valued, growing, and delivering results
• Contribute to succession planning, talent assessment, and performance and promotion processes; ensure staff are appropriately recognised and developed
• Coach and mentor team members to support their ongoing development

Minimum Qualification Requirements

• Bachelor’s degree in a science related field from an accredited college or university; or equivalent qualifications/experience (10+ years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development, minimum of 3 years in leadership role)
• Experience with regulations and guidelines that apply to the conduct of clinical trials
• Project management and time management skills
• Experience of coaching and mentoring others
• Ability to work effectively cross-culturally and in a virtual work environment
• Ability to influence both internal and external environments appropriately and forge strong working relationships
• Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
• Strong verbal reasoning, attention to detail, negotiation skills, critical thinking, problem solving, and analytical abilities