Associate Director - PK/PD Operations

Key Skills

Data science techniques, Effective communication skills, Operations, Statistics

Job Description

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.

Primary Responsibilities:

• 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.

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.

Additional preferred criteria:

• Supervisory experience.
• Proven ability to work independently and adapt to evolving priorities in a fast-paced environment.
• 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) 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.