Eli Lilly and Company
Clinical Pharmacologist/Clinical Research Physician
Eli Lilly and Company, Arlington, Texas, United States, 76000
Clinical Pharmacologist/Clinical Research Physician page is loaded## Clinical Pharmacologist/Clinical Research Physicianlocations:
US, Remote:
GB: Arlington Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
R-98706At 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.**Purpose and Role**Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline.
The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas.
The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies.Through the application of scientific and medical training, the CRP 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, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders.The CRP 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. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed.**Basic Qualifications*** Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). 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). For the recognized list of foreign medical schools and the disapproved list, see
and* Must be board eligible or certified in appropriate specialty/subspecialty 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.**Additional Skills/Preferences*** At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management).* Pharmaceutical company experience preferable.* Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable.* Experience in Clinical Pharmacology preferable.* Additional scientific training or degree (M.S., Ph.D.) preferable.* Fluent in English; both written and verbal communications.* Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.* Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment.* Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%).**Core Job Responsibilities**The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical 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 for first-in-human dosing studies including biomarker plans.* Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical 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 Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 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 biopharmaceutical submission plan.***Clinical Research/Trial Execution and Support**** Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic 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 #J-18808-Ljbffr
US, Remote:
GB: Arlington Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
R-98706At 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.**Purpose and Role**Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline.
The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas.
The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies.Through the application of scientific and medical training, the CRP 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, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders.The CRP 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. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed.**Basic Qualifications*** Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). 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). For the recognized list of foreign medical schools and the disapproved list, see
and* Must be board eligible or certified in appropriate specialty/subspecialty 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.**Additional Skills/Preferences*** At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management).* Pharmaceutical company experience preferable.* Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable.* Experience in Clinical Pharmacology preferable.* Additional scientific training or degree (M.S., Ph.D.) preferable.* Fluent in English; both written and verbal communications.* Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.* Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment.* Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%).**Core Job Responsibilities**The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical 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 for first-in-human dosing studies including biomarker plans.* Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical 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 Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 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 biopharmaceutical submission plan.***Clinical Research/Trial Execution and Support**** Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic 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 #J-18808-Ljbffr