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

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.

Job Responsibilities

• 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

• 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

• 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

• Serve as a key partner and point of accountability for the integration of clinical delivery capabilities with TPO partners in support of the exploratory and biopharmaceutics portfolio

• 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

• 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 travel (up to 10% expected – varies dependent on responsibilities)

Preferred Qualifications

• 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