Eli Lilly and Company
Executive Medical Director - Cardio-Renal
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Overview
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 put people first and are looking for people who are determined to make life better for people around the world. PurPose of the Job
Lilly has innovated in diabetes care since 1923, when we introduced the world's first commercial insulin. We are currently building upon this heritage by working to meet the diverse needs of people with diabetes, obesity, and complications. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by these diseases and those who care for them. Today, Lilly aims to become the next leader in cardiovascular and renal diseases. We are looking for physician/scientists to provide clinical development leadership to a rapidly expanding cardio-renal portfolio. The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development and should have broad scientific expertise in cardiovascular diseases. Additional experience in renal diseases is a bonus. They should have a demonstrated track record of developing clinical development strategies and trials in various diseases including, but not limited to, heart failure, ASCVD, hypertension, pulmonary hypertension, and/or CKD. The Executive Director will work with preclinical teams to develop sound preclinical strategies to progress molecules to first-in-human trials and develop sound clinical development strategies and trials across all phases of development consistent with best clinical practices. They will conduct and support clinical trials in each phase of development and support commercial decisions for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will supervise the implementation of global clinical trials; report adverse events as mandated by corporate patient safety; review protocols, study reports, publications, regulatory submissions and data dissemination. The Executive Director will engage with regulatory bodies worldwide and other governmental agencies as needed, and engage external medical and scientific experts to represent Lilly and to involve them in molecule development and trial implementation. The Executive Director must ensure that all activities of the medical team comply with current local and international regulations, laws, guidance, Good Clinical Practices (GCPs), Lilly policies and procedures, and the Principles of Medical Research. Core Job Responsibilities
The core job responsibilities include those listed below as well as all other duties as assigned. Clinical Planning
Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels and Value Propositions that address key customer needs (patient, provider, and payer); are consistent with known biological characteristics and effects of the molecule; consider all appropriate clinical strategies, development plans and study protocol designs. Contribute to global alignment of clinical strategy and clinical plans with business unit and long-range plan priorities. Understand and keep updated with the pre-clinical and clinical data relevant to molecules. Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development are discussed. Clinical Research/Trial Execution and Support
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions). Review and approve risk profiles to ensure appropriate communication of risk to study subjects. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the operating team has documented the completion of administrative requirements for study initiation and conduct (ethical review board, informed consent, regulatory approval/notification) consistent with GCPs and local laws. Assist in planning processes and participate in study start-up meetings and other activities to provide training and information to investigators and site personnel. Serve as a resource to clinical operations personnel, clinical research monitors, investigators and ethical review boards to address questions or clarify issues during study conduct. Understand and address the scientific information needs of investigators and personnel. Monitor patient safety during studies and track adverse events in alignment with corporate patient safety policies. Scientific Data Dissemination/Exchange
Ensure compliance with local and global policies on data dissemination and interactions with external healthcare professionals. Maintain knowledge of clinical research methodology and latest developments in biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards. Address unsolicited scientific information needs of external healthcare professionals per guidelines. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support planning of symposia, advisory boards, and other meetings with healthcare professionals. Prepare or review scientific information in response to investigator questions or media requests. Support data analysis and development of slide sets and publications (abstracts, posters, manuscripts). Establish and maintain collaborations with external experts, thought leaders and the medical community; develop relationships with professional societies. Support design of customer research as medical expert in collaboration with New Product Planning. Support training of medical personnel and provide guidance to geographic/affiliate CRPs, medical and outcomes liaisons, and health outcomes personnel. Provide technical support for due diligence activities as needed. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications. Regulatory Support Activities
Participate in development and review of regulatory documents globally in collaboration with affiliates, regulatory, and legal. Provide medical expertise to regulatory scientists. Support preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADEs), and regulatory interactions from a global perspective. Participate in meetings with FDA, EMEA and other regulatory bodies as needed. Participate in risk management planning with affiliates and Global Patient Safety. Business/ Customer Support (Pre and Post Launch)
Contribute to the development of medical strategies to support brand commercialization by working with the business unit, New Product Planning, and business development. Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers). Address customer questions by leading data analyses and new clinical or health outcomes research efforts. Establish collaborations with New Product Planning and Health Outcomes personnel to support demand realization. Maintain contact with external experts and opinion leaders to sustain scientific credibility. Contribute as a medical expert to PRA activities (pricing, reimbursement, and access) by providing clinical input for compound valuations. Review and support New Product Planning, probabilistic assessments and valuation activities as needed. Understand market archetypes and potential influence on medical interventions for the product. Participate in payer, commercialization and regulatory advisory boards. Scientific / Technical Expertise and continued development Critically read and evaluate relevant medical literature; stay informed about data from competitive molecules and current developments in the field. Disseminate information on pathophysiology, diagnosis, etiology, treatment and management of diseases related to the supported molecules. Be aware of trends and projections for clinical practice and access in the therapeutic areas. Explore opportunities for extramural scientific experiences. General Responsibilities
Support the management team in preparation and administration of the development budget. Set and meet professional development goals and coach others. Maintain qualification and training, including a current curriculum training map for self. Model effective leadership and act as an ambassador for the Lilly Brand. Basic Qualifications: Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in the appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the LCME. For the recognized list of foreign medical schools and the disapproved list, see the publicly available reference. Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large globally conducted clinical trials or equivalent activities. Additional Skills/Preferences: Ideal additional qualification for business acumen. Ideal five years of experience in clinical practice with at least 2 years in cardiovascular or renal medicine. Must be legally authorized to work in the United States; Lilly does not provide visa sponsorship for this position. Demonstrated ability to lead and manage groups of professionals. Strong administrative, teamwork, and governance skills; excellent communication, interpersonal, and negotiation abilities. Lilly is dedicated to helping individuals with disabilities and ensuring equal opportunities in the workforce. If accommodation is required to submit a resume, please complete the accommodation request form (link not included here). Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $336,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program including retirement and health benefits. Lilly reserves the right to amend, modify, or terminate compensation and benefit programs at its discretion. #WeAreLilly
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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 put people first and are looking for people who are determined to make life better for people around the world. PurPose of the Job
Lilly has innovated in diabetes care since 1923, when we introduced the world's first commercial insulin. We are currently building upon this heritage by working to meet the diverse needs of people with diabetes, obesity, and complications. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by these diseases and those who care for them. Today, Lilly aims to become the next leader in cardiovascular and renal diseases. We are looking for physician/scientists to provide clinical development leadership to a rapidly expanding cardio-renal portfolio. The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development and should have broad scientific expertise in cardiovascular diseases. Additional experience in renal diseases is a bonus. They should have a demonstrated track record of developing clinical development strategies and trials in various diseases including, but not limited to, heart failure, ASCVD, hypertension, pulmonary hypertension, and/or CKD. The Executive Director will work with preclinical teams to develop sound preclinical strategies to progress molecules to first-in-human trials and develop sound clinical development strategies and trials across all phases of development consistent with best clinical practices. They will conduct and support clinical trials in each phase of development and support commercial decisions for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will supervise the implementation of global clinical trials; report adverse events as mandated by corporate patient safety; review protocols, study reports, publications, regulatory submissions and data dissemination. The Executive Director will engage with regulatory bodies worldwide and other governmental agencies as needed, and engage external medical and scientific experts to represent Lilly and to involve them in molecule development and trial implementation. The Executive Director must ensure that all activities of the medical team comply with current local and international regulations, laws, guidance, Good Clinical Practices (GCPs), Lilly policies and procedures, and the Principles of Medical Research. Core Job Responsibilities
The core job responsibilities include those listed below as well as all other duties as assigned. Clinical Planning
Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels and Value Propositions that address key customer needs (patient, provider, and payer); are consistent with known biological characteristics and effects of the molecule; consider all appropriate clinical strategies, development plans and study protocol designs. Contribute to global alignment of clinical strategy and clinical plans with business unit and long-range plan priorities. Understand and keep updated with the pre-clinical and clinical data relevant to molecules. Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development are discussed. Clinical Research/Trial Execution and Support
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions). Review and approve risk profiles to ensure appropriate communication of risk to study subjects. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the operating team has documented the completion of administrative requirements for study initiation and conduct (ethical review board, informed consent, regulatory approval/notification) consistent with GCPs and local laws. Assist in planning processes and participate in study start-up meetings and other activities to provide training and information to investigators and site personnel. Serve as a resource to clinical operations personnel, clinical research monitors, investigators and ethical review boards to address questions or clarify issues during study conduct. Understand and address the scientific information needs of investigators and personnel. Monitor patient safety during studies and track adverse events in alignment with corporate patient safety policies. Scientific Data Dissemination/Exchange
Ensure compliance with local and global policies on data dissemination and interactions with external healthcare professionals. Maintain knowledge of clinical research methodology and latest developments in biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards. Address unsolicited scientific information needs of external healthcare professionals per guidelines. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support planning of symposia, advisory boards, and other meetings with healthcare professionals. Prepare or review scientific information in response to investigator questions or media requests. Support data analysis and development of slide sets and publications (abstracts, posters, manuscripts). Establish and maintain collaborations with external experts, thought leaders and the medical community; develop relationships with professional societies. Support design of customer research as medical expert in collaboration with New Product Planning. Support training of medical personnel and provide guidance to geographic/affiliate CRPs, medical and outcomes liaisons, and health outcomes personnel. Provide technical support for due diligence activities as needed. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications. Regulatory Support Activities
Participate in development and review of regulatory documents globally in collaboration with affiliates, regulatory, and legal. Provide medical expertise to regulatory scientists. Support preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADEs), and regulatory interactions from a global perspective. Participate in meetings with FDA, EMEA and other regulatory bodies as needed. Participate in risk management planning with affiliates and Global Patient Safety. Business/ Customer Support (Pre and Post Launch)
Contribute to the development of medical strategies to support brand commercialization by working with the business unit, New Product Planning, and business development. Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers). Address customer questions by leading data analyses and new clinical or health outcomes research efforts. Establish collaborations with New Product Planning and Health Outcomes personnel to support demand realization. Maintain contact with external experts and opinion leaders to sustain scientific credibility. Contribute as a medical expert to PRA activities (pricing, reimbursement, and access) by providing clinical input for compound valuations. Review and support New Product Planning, probabilistic assessments and valuation activities as needed. Understand market archetypes and potential influence on medical interventions for the product. Participate in payer, commercialization and regulatory advisory boards. Scientific / Technical Expertise and continued development Critically read and evaluate relevant medical literature; stay informed about data from competitive molecules and current developments in the field. Disseminate information on pathophysiology, diagnosis, etiology, treatment and management of diseases related to the supported molecules. Be aware of trends and projections for clinical practice and access in the therapeutic areas. Explore opportunities for extramural scientific experiences. General Responsibilities
Support the management team in preparation and administration of the development budget. Set and meet professional development goals and coach others. Maintain qualification and training, including a current curriculum training map for self. Model effective leadership and act as an ambassador for the Lilly Brand. Basic Qualifications: Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in the appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the LCME. For the recognized list of foreign medical schools and the disapproved list, see the publicly available reference. Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large globally conducted clinical trials or equivalent activities. Additional Skills/Preferences: Ideal additional qualification for business acumen. Ideal five years of experience in clinical practice with at least 2 years in cardiovascular or renal medicine. Must be legally authorized to work in the United States; Lilly does not provide visa sponsorship for this position. Demonstrated ability to lead and manage groups of professionals. Strong administrative, teamwork, and governance skills; excellent communication, interpersonal, and negotiation abilities. Lilly is dedicated to helping individuals with disabilities and ensuring equal opportunities in the workforce. If accommodation is required to submit a resume, please complete the accommodation request form (link not included here). Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $336,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program including retirement and health benefits. Lilly reserves the right to amend, modify, or terminate compensation and benefit programs at its discretion. #WeAreLilly
#J-18808-Ljbffr