Unite Caring with Discovery
Lilly is a global healthcare leader dedicated to making life better for people around the world. We strive to discover and bring life-changing medicines, improve disease understanding and management, and give back to our communities through philanthropy and volunteerism.
We are the Global Pharmacokinetics/Pharmacodynamics (PK/PD) and Pharmacometrics Department at Lilly, seeking talent to join our newly formed Operational Team. Our goal is to identify the right dose of the right drug for the right patient and live the model-informed drug discovery and development (MIDD) paradigm.
Pk/pd Operations Team Responsibilities
* Regulatory Expertise:
o Familiarity with global regulatory requirements for each region.
o Advise PK/PD Scientists on requirements to support submission deliverables.
o Assist on packaging submission deliverables and regulatory responses.
o Coordinate PK/PD deliverables with Global Regulatory Affairs Regulatory Scientists.
o Develop critical product registration timelines and electronic submission structure and content requirements.
* Pk/pd Scientific and Technical Knowledge:
o Understanding of PK/PD analyses, data reporting and dataset requirements, and common technical documents for submissions.
o Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK/PD data, adhering to established standards.
o Contribute to process improvement initiatives to enhance efficiency, leveraging best practices, and innovative approaches.
o Collaborate with cross-functional teams to deliver submission documents.
Minimum Requirements:
* BSc in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or health-related discipline.
* Understanding of Pharmacokinetics/Pharmacodynamics principles.
* Regulatory experience in a pharmaceutical or biotech setting.
Additional Skills/Preferences:
* Knowledge of regulatory and compliance guidelines.
* Understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.
* Knowledge of Clinical Quality work processes and GCP compliance.
* Excellent organizational and time management skills.
* Proven ability to work independently and adapt to evolving priorities in a fast-paced environment.
* Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.