Clinical Research Scientist (CRS)

Employment Type: Full time

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.

Position Overview

The Clinical Research Scientist (CRS) is an integral member of the medical affairs, development, or a business unit brand team. Through the application of scientific and clinical training and expertise, the CRS supports strategic planning for launch and commercialization activities to meet patient needs and enhance customer experience. Customers include patients, providers (HCPs), and payers.

The CRS may also collaborate with global Development teams, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine teams in new product development across all drug development and clinical trial phases.

Responsibilities

The primary responsibility of the Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local business, ultimately enhancing customer experience. This includes:

• Local Marketed Product Support: Participating in the development of the "patient journey" and the strategic plan for the compound.
• Clinical/Medical Planning: Developing or contributing to global and/or regional clinical/medical plans within their therapeutic area.
• Local Clinical Trials: Developing, conducting, and reporting on local clinical trials.
• Global Clinical Trial Implementation: Implementing global clinical trials conducted in local affiliates/countries.
• Adverse Event Reporting: Reporting adverse events as mandated by corporate patient safety.
• Review Processes: Reviewing protocols, study reports, publications, and data dissemination for products.
• Labeling and Documentation: Contributing to new and updated labels, documents, and tools supporting product pricing, reimbursement, and access (PRA).
• Grant Submissions and Contracts: Managing grant submissions and contracts.
• Regulatory Interactions: Engaging with regulatory and other governmental agencies.
• External Outreach: Conducting outreach medical activities aimed at the external clinical customer community, including thought leaders.
• Demand Realization: Supporting various medical activities for demand realization.
• Strategic Alignment: Ensuring all activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s), with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader.
• Scientific Resource: Serving as a scientific resource for study teams, departments, and others as needed.
• Compliance: Being aware of and ensuring all activities of the medical team (and direct reports, if applicable) comply with current local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research, and aligning activities with the medical vision.

Note: This job description provides a general overview. Job requirements may change over time and may include additional responsibilities not specifically described. Consult with your supervision regarding actual job responsibilities and any related duties.