PK/PD Operations Manager

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ&#43; & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! The role The Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics (PK/PD/PMx) Department serves as the functional leader in research and development across the value chain, from preclinical lead molecule identification through clinical post-approval. Our mission is to accelerate the development of innovative medicines by applying mechanistic reasoning and quantitative modeling to complex systems. We partner across disciplines to simplify and enable critical decisions. We are leaders in model-informed drug discovery and development. Using deep quantitative thinking, we work best with hard questions, and our insight shapes the medicines that reach patients. We're looking for a leader of our Clinical PK/PD Operations Team. The team enables PKPD-informed clinical decisions through quantitative operational excellence, providing end-to-end data operationalization from protocol to insight, and executing against our vision to enable and accelerate Model-Informed Drug Development across Lilly's portfolio. As the Clinical PK/PD Operations Team Lead, you will oversee and manage the day-to-day operations of our Clinical PK/PD Operations team while driving its strategic maturity across four priority areas: training and upskilling, automation and standardization, roles and responsibilities, and strategic assignments. You will provide leadership to team members, collaborate with Global PK/PD/PMx leadership and cross-functional teams, and apply your knowledge of data science, clinical trial operations, clinical pharmacology, PK/PD, or related scientific and technical expertise to continuously improve how the team operates. We seek dynamic, energetic, curious, and collaborative PK/PD data scientists, clinical operations specialists, or Clinical Pharmacologists with a passion for clinical PK/PD strategy, operations, and team leadership, ready to engage and work on life-changing therapies for patients. Consider joining Team Lilly in Cork to contribute to Lilly's drug discovery and development efforts. Primary Responsibilities: Team Leadership: Lead, mentor, and manage a team of Clinical PKPD Operations Associates. Foster a collaborative, innovative, and high-performance work environment. Provide guidance and support for professional development and career growth of team members, including structured training and upskilling pathways. Hire, onboard, and train new group members, as necessary. Clinical PK/PD Operational Oversight: Monitor and track group deliverables, troubleshoot, and ensure on-time, quality delivery. Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs. Clarify and continuously refine roles, responsibilities, and interaction models across the team to reduce ambiguity and improve cross-team handoffs. Collaboration and Communication: Serve as the primary point of contact for internal stakeholders regarding Clinical PK/PD operations. Collaborate with cross-functional teams, including clinical development, bioanalytical, data management, and regulatory affairs. Communicate progress, challenges, and results to senior management and stakeholders. Automation and Continuous Improvement: Identify opportunities for process improvement and automation in Clinical PK/PD operations, and implement standardized, scalable solutions that translate the Global PK/PD/PMx vision into operational reality. Stay current with industry trends, technologies, and regulatory changes. Strategic Assignments: Identify and lead cross-functional or portfolio-level initiatives that extend the team's impact beyond routine operations, partnering with Global PK/PD/PMx leadership to align the team's work with department-wide priorities. Basic Requirements: MSc in a relevant scientific field, such as pharmaceutical sciences, clinical pharmacology, pharmacometrics, engineering, statistics, data science, or a health-related discipline, or Doctor of Pharmacy (PharmD) Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders Good understanding of clinical pharmacology (PK/PD and pharmacometrics) principles At least 5 years of working experience in pharmaceutical or related industry, regulatory, consulting, or academia Demonstrated ability to lead as a matrix leader or direct team leader Strong commitment to continued learning as a leader Proven ability to work independently and adapt to evolving priorities in a fast-paced environment Additional Preferred Criteria: Extensive working experience in pharmaceutical industry, regulatory, consulting, or academia in the field of Clinical Pharmacology, PK/PD, and/or Clinical Operations Direct supervisory experience preferred Experience driving process improvement, standardization, or automation initiatives within an operational or scientific team Excellent and proven communication skills with strong interactions across multi-disciplinary teams 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</s