Early Development Clinical Research Physician - EMP Immunology & Oncology
Eli Lilly and Company
2024-11-17 14:54:05
Indianapolis,
Indiana,
United States
Job type: fulltime
Job industry: Healthcare & Medical
Job description
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.
- 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.
- Design, create, and provide oversight for protocol development.
- Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
- Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group.
- Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
- Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures.
- Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
- Provide appropriate oversight and partnership with Third Party Organizations and sites to ensure successful study execution.
- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process.
- Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies.
- Publish results of research projects as appropriate.
- Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials.
- Provide clinical reports for local and international regulatory purposes.
- Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
- Develop, and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience
- Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness
- Develop an organizational talent base that demonstrates judgment-based risk taking and decision making
- Business customer support (pre and post launch support)
- Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
- Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) . click apply for full job details