Associate Director - PK/PD Operations

at  Lilly

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.

ORGANISATION OVERVIEW:

At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 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, Age & Culture, LGBTQ+ 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!

PKPD OVERVIEW:

We are the Global Pharmacokinetics/Pharmacodynamics (PK/PD) and Pharmacometrics Department at Lilly, and we’re looking for talent to lead our newly formed Operational Team. We work with the goal of identifying the right dose of the right drug for the right patient and living the model-informed drug discovery and development (MIDD) paradigm. The PK/PD Operations Team works to streamline, manage, and oversee departmental deliverables.
As a PK/PD Operations Manager, you will oversee and manage the day-to-day operations of our PKPD Operations team. You will be responsible for ensuring the successful execution of PKPD Operations workflows, providing leadership to team members, and collaborating with Global PK/PD leadership and other cross-functional teams to develop, grow and evolve the team capabilities. You will apply your knowledge of data science, clinical trial operations, PK/PD, or related scientific and technical knowledge to streamline and automate for continuous process improvements.
We seek dynamic, energetic, curious, and collaborative data scientists, project managers, clinical operations specialists, or general scientists with a passion for operations and team leadership, ready to engage and work on life-changing therapies for patients. We are passionate about making an impact in the lives of our patients and pushing the boundaries of science. Consider joining Team Lilly in Cork to contribute to Lilly’s drug discovery and development efforts.

BASIC REQUIREMENTS:

• MSc in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or 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 working experience in pharmaceutical or related industry, regulatory, consulting or academia.

• Team Leadership: Lead, mentor, and manage a team of PKPD scientists and operational staff. Foster a collaborative, innovative, and high-performance work environment. Provide guidance and support for professional development and career growth of team members. Hire, onboard and train new group members, as necessary.
• PK/PD Operational Oversight: Monitor and track the group deliverables, troubleshoot, and ensure on time, quality, delivery. Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs (Standard Operating Procedures).
• Collaboration and Communication: Serve as the primary point of contact for internal stakeholders regarding PKPD 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.
• Continuous Improvement & Automation: Identify opportunities for process improvements in PKPD operations. Implement best practices and innovative solutions to enhance efficiency and quality. Stay current with industry trends, technologies, and regulatory changes.