Clinical Pharmacologist, FSP – Neurology/Immuno Oncology & Metabolic – Remote US
Responsibilities
Through the application of pharmacological training, expertise and relevant therapeutic area experience , the Clinical Pharmacologist (CP) participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the 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.
The CP may be called upon to participate on additional items including but not limited to internal executive and governance presentations, external key opinion leader interactions, medical outreach/advocacy, and industry conferences.
Core Job Responsibilities
The primary responsibilities of the CP 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 2 and 3 studies for early phase and/or detailed biopharm plan to support submission.
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 other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models.
Contribute, as an integral member of the Clinical Pharmacology team, to global Phase I and II 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. 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…