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 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
- 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
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 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$156,000 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly