Eli Lilly
Executive Director, Cardio-Renal Research
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. The purpose of the job is 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 leverage their scientific training, clinical expertise, and relevant experience to 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. They will support commercial decision for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will also supervise 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, regulatory submissions, and data dissemination. The Executive Director will take a leadership role in interactions with regulatory bodies worldwide and other governmental agencies as needed to advance the clinical development. They will also engage external medical and scientific experts as needed to represent Lilly and to engage them in the development of molecules and implementation of clinical trials. The Executive Director must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research. Core job responsibilities include: Collaborate with preclinical groups, clinical pharmacology, health outcomes, and new product planning in the development and maintenance of draft launch labels and value propositions. Contribute to global alignment of clinical strategy and clinical plans with business unit and LRL 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. Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials. 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 operational team has documented the completion of administrative requirements for study initiation and conduct. 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 operations personnel / clinical research monitors, investigators, and ethical review boards. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events. 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. Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Prepare or review scientific information in response to investigator questions or media requests. Support data analysis and the development of slide sets and publications. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert in collaboration with New Product Planning. Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome 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. Participate in development and review of regulatory documents globally in collaboration with affiliates, regulatory, and legal. Provide medical expertise to regulatory scientists. Support the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses, and Periodic Adverse Drug Experience Reports. Participate in face to face meetings with FDA, EMEA, and other regulatory bodies as needed. Participate in risk management planning along with affiliates and Global Patient Safety. Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development. Understand the scientific information needs of all development customers. Actively address development customer questions in a timely fashion. Establish effective collaborations with New Product Planning and Health Outcomes personnel. Establish and maintain contact with external experts and opinion leaders. Contribute as a scientific and medical expert to activities and deliverables of the PRA organization. Review, offer scientific and creative support for, New Product Planning, technical probability assessments, and valuation activities. Become familiar with market archetypes and potential influence on the medical interventions for the product. Participate in payer, commercialization, and regulatory advisory boards. Scientific / Technical Expertise and continued development: Critically read and evaluate the relevant medical literature. Maintain and disseminate information on latest developments in the pathophysiology, diagnosis, etiology, treatment, and management of disease states. Be aware of current trends and projections for clinical practice and access. Explore and take advantage of opportunities for extramural scientific experiences. General Responsibilities: Support the management team in preparation and administration of the development budget. Actively set and meet individual professional development goals and contribute to the development of others. Ensures that at all times is adequately qualified and trained in the tasks required to perform. Model effective leadership behaviors. Be an ambassador for the Lilly Brand. Basic Qualifications: Medical Doctor or Doctor of Osteopathy. 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. 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 Liaison Committee on Medical Education (LCME). Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials or other qualifying activities. Additional Skills/Preferences: Ideal would be additional qualification for business acumen. Ideal Five years of experience in clinical practice with at least 2 years in cardiovascular or renal medicine. Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Demonstrated evidence for the capacity to lead and manage groups
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. The purpose of the job is 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 leverage their scientific training, clinical expertise, and relevant experience to 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. They will support commercial decision for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will also supervise 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, regulatory submissions, and data dissemination. The Executive Director will take a leadership role in interactions with regulatory bodies worldwide and other governmental agencies as needed to advance the clinical development. They will also engage external medical and scientific experts as needed to represent Lilly and to engage them in the development of molecules and implementation of clinical trials. The Executive Director must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research. Core job responsibilities include: Collaborate with preclinical groups, clinical pharmacology, health outcomes, and new product planning in the development and maintenance of draft launch labels and value propositions. Contribute to global alignment of clinical strategy and clinical plans with business unit and LRL 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. Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials. 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 operational team has documented the completion of administrative requirements for study initiation and conduct. 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 operations personnel / clinical research monitors, investigators, and ethical review boards. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events. 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. Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Prepare or review scientific information in response to investigator questions or media requests. Support data analysis and the development of slide sets and publications. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert in collaboration with New Product Planning. Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome 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. Participate in development and review of regulatory documents globally in collaboration with affiliates, regulatory, and legal. Provide medical expertise to regulatory scientists. Support the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses, and Periodic Adverse Drug Experience Reports. Participate in face to face meetings with FDA, EMEA, and other regulatory bodies as needed. Participate in risk management planning along with affiliates and Global Patient Safety. Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development. Understand the scientific information needs of all development customers. Actively address development customer questions in a timely fashion. Establish effective collaborations with New Product Planning and Health Outcomes personnel. Establish and maintain contact with external experts and opinion leaders. Contribute as a scientific and medical expert to activities and deliverables of the PRA organization. Review, offer scientific and creative support for, New Product Planning, technical probability assessments, and valuation activities. Become familiar with market archetypes and potential influence on the medical interventions for the product. Participate in payer, commercialization, and regulatory advisory boards. Scientific / Technical Expertise and continued development: Critically read and evaluate the relevant medical literature. Maintain and disseminate information on latest developments in the pathophysiology, diagnosis, etiology, treatment, and management of disease states. Be aware of current trends and projections for clinical practice and access. Explore and take advantage of opportunities for extramural scientific experiences. General Responsibilities: Support the management team in preparation and administration of the development budget. Actively set and meet individual professional development goals and contribute to the development of others. Ensures that at all times is adequately qualified and trained in the tasks required to perform. Model effective leadership behaviors. Be an ambassador for the Lilly Brand. Basic Qualifications: Medical Doctor or Doctor of Osteopathy. 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. 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 Liaison Committee on Medical Education (LCME). Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials or other qualifying activities. Additional Skills/Preferences: Ideal would be additional qualification for business acumen. Ideal Five years of experience in clinical practice with at least 2 years in cardiovascular or renal medicine. Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Demonstrated evidence for the capacity to lead and manage groups