Early Development Clinical Research Physician - EMP Immunology & Oncology

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities

Through the application of medical and/or pharmacological training, expertise and relevant therapeutic area experience , the Early Development Clinical Research Physician participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, medical monitoring and the reporting of adverse events as mandated by corporate patient safety; the generation and review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders.  In addition, the CP works with the basic research scientists to identify lead compounds and plan pre-clinical studies as well as network with the Business Unit to plan for the clinical pharmacology submission package.  The CP serves as a scientific resource for study teams, departments, and others as needed.
The CP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.
 
Core Job Responsibilities

The primary responsibilities of the Early Development Clinical Research Physician are generally related to clinical pharmacology including early phase exploratory and late phase biopharm submission studies.
 
The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

Clinical Planning

• Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission.

• Support preparation of high-level plan for phase 1, 2 and 3 studies for early phase and/or detailed biopharm plan to support submission or post-marketing commitment studies.

• Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies.

• Collaborate with quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations, CLS), CMC, SMDD, and DDCS and additional functions to integrate study development and conduct with disease-progression, drug­ disease response models and/or digital health technologies, and devices etc.

• Contribute, as an integral member of the Clinical Pharmacology team, to global Phase I clinical studies as well as submission planning activities.

• Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.

• Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharm submission plan.

 Clinical Research/Trial Execution and Support

• Design and oversee implementation of all clinical pharmacology studies, including Ph1 FHDs, biopharm studies. and exploratory medicine studies.  Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations.

• Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.

• Design and oversee implementation methods for development and biomarker qualification studies.