Clinical Research Scientist

Position Overview

The Clinical Research Scientist (CRS) is an integral member of the medical affairs, development, or a business unit brand team, providing strategic planning support for the launch and commercialization activities to meet patient needs and enhance customer experience. The CRS works closely with global Development teams, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine teams throughout the drug development lifecycle.

Responsibilities

• Develop or contribute to global and/or regional clinical/medical plans within their therapeutic area.
• Develop, conduct, and report on local clinical trials.
• Implement global clinical trials conducted in local affiliates/countries.
• Report adverse events as mandated by corporate patient safety.
• Participate in the review process for protocols, study reports, publications, and data dissemination.
• Support new and updated labels, documents, and tools for pricing, reimbursement, and access (PRA).
• Manage grant submissions and contracts.
• Liaise with regulatory and other governmental agencies.
• Engage in outreach medical activities with the external clinical customer community, including thought leaders.
• Support various medical activities to drive demand realization.
• Ensure alignment of activities with the strategic priorities of respective Medical Affairs business unit brand teams, global Development teams, and other relevant scientific teams.
• Serve as a scientific resource for study teams and other departments.
• Ensure all activities comply with local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies, global quality standards, and the Principles of Medical Research.
• Provide expert scientific and clinical support to local business operations.
• Gather and communicate scientific intelligence and clinical insights from interactions with Scientific Experts, Health Care Providers, Scientific Exchange Meetings, and medical conferences to inform Lilly's strategic direction.
• Support local marketed products, including participation in the development of the "patient journey."

Requirements

• Application of scientific and clinical training and expertise.
• Awareness of and adherence to current local and international regulations, laws, and guidance.
• Adherence to Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and global quality standards.

Company Information

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.

Employment Type

Full time

Salary

• Salary information not provided.

Location Type

• Location type not provided.