Eli Lilly and Company
Executive Medical Director - Cardio-Renal
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Executive Medical Director - Cardio-Renal
Join to apply for the Executive Medical Director - Cardio-Renal role at Eli Lilly and Company. Lilly is a global healthcare leader committed to discovering and bringing life-changing medicines to people in need. We pursue science with a people-first approach and work to advance care in cardiovascular and renal diseases, among other areas. Purpose of the job
Lilly seeks 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, with additional experience in renal diseases being a bonus. The role involves developing clinical development strategies and trials across various diseases including, but not limited to heart failure, ASCVD, hypertension, pulmonary hypertension, and CKD. The Executive Director will lead sound preclinical and clinical development strategies across all phases, supervise global clinical trials, oversee reporting of adverse events, review protocols and regulatory submissions, and engage with regulatory bodies and external experts as needed.
The Executive Director will ensure activities comply with applicable regulations, GCPs, Lilly policies, and the Principles of Medical Research. Core Job Responsibilities
Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning to develop and maintain draft launch labels and value propositions addressing key customer needs, consistent with the molecule’s biology and development plans. Contribute to global alignment of clinical strategy with business unit and LRL priorities. Understand and stay updated with relevant pre-clinical and clinical data for molecules. Represent Lilly in external forums to align on standards, protocols, assessment instruments, regulatory standards and guidelines. Clinical planning and trial execution and support: Collaborate with clinical research staff in design, conduct and reporting of local clinical trials; review risk profiles; participate in investigator identification and site training; ensure regulatory and ethical requirements are met; monitor patient safety and adverse events; support training and study start-up activities; provide guidance to investigators and sites. Scientific data dissemination: Ensure compliance with local/global data dissemination guidelines; support data analysis, publications, and collaborations with external experts; assist in planning symposia and meetings; prepare scientific responses to inquiries. Regulatory support: Participate in development and review of regulatory documents; provide medical expertise to regulatory scientists; assist in regulatory reports and FDA interactions as needed. Business/customer support: Contribute to medical strategies supporting brand commercialization; address informational needs of development customers; foster collaborations with New Product Planning and Health Outcomes; engage external experts and thought leaders; support payer, regulatory advisory activities. Scientific/technical expertise and development: Stay current with medical literature and developments; disseminate knowledge within Lilly; monitor trends in clinical practice and access; pursue extramural scientific opportunities. General responsibilities: Budget support, professional development, training, leadership, and brand representation. Basic Qualifications
Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty; US-trained physicians must have board eligibility/certification. Non-US trained physicians may be hired at the discretion of the Chief Medical Officer. Five years of experience in clinical research or drug development, including large global trials or equivalent qualifying activities; education and training requirements per LCME for non-US graduates. Legal eligibility to work in the United States; Lilly does not typically sponsor work visas for this position. Additional Skills/Preferences
Business acumen and five years of clinical practice with at least 2 years in cardiovascular or renal medicine are preferred. Demonstrated leadership and administrative skills; ability to work within Lilly governance; strong communication, interpersonal, and negotiation skills. Commitment to diversity and inclusion; willingness to engage with payer and health care professionals and to operate in a global regulatory environment. Lilly is an equal opportunity employer. Accommodation requests for the application process can be submitted via the workplace accommodation form. See Lilly’s EEO policy for details on protected statuses and inclusion. Our ERGs support a diverse workforce. Compensation: Actual compensation will depend on education, experience, and location. This role is a full-time position with possible eligibility for a company bonus and comprehensive benefits, including 401(k), pension, health coverage, and other well-being programs.
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Join to apply for the Executive Medical Director - Cardio-Renal role at Eli Lilly and Company. Lilly is a global healthcare leader committed to discovering and bringing life-changing medicines to people in need. We pursue science with a people-first approach and work to advance care in cardiovascular and renal diseases, among other areas. Purpose of the job
Lilly seeks 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, with additional experience in renal diseases being a bonus. The role involves developing clinical development strategies and trials across various diseases including, but not limited to heart failure, ASCVD, hypertension, pulmonary hypertension, and CKD. The Executive Director will lead sound preclinical and clinical development strategies across all phases, supervise global clinical trials, oversee reporting of adverse events, review protocols and regulatory submissions, and engage with regulatory bodies and external experts as needed.
The Executive Director will ensure activities comply with applicable regulations, GCPs, Lilly policies, and the Principles of Medical Research. Core Job Responsibilities
Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning to develop and maintain draft launch labels and value propositions addressing key customer needs, consistent with the molecule’s biology and development plans. Contribute to global alignment of clinical strategy with business unit and LRL priorities. Understand and stay updated with relevant pre-clinical and clinical data for molecules. Represent Lilly in external forums to align on standards, protocols, assessment instruments, regulatory standards and guidelines. Clinical planning and trial execution and support: Collaborate with clinical research staff in design, conduct and reporting of local clinical trials; review risk profiles; participate in investigator identification and site training; ensure regulatory and ethical requirements are met; monitor patient safety and adverse events; support training and study start-up activities; provide guidance to investigators and sites. Scientific data dissemination: Ensure compliance with local/global data dissemination guidelines; support data analysis, publications, and collaborations with external experts; assist in planning symposia and meetings; prepare scientific responses to inquiries. Regulatory support: Participate in development and review of regulatory documents; provide medical expertise to regulatory scientists; assist in regulatory reports and FDA interactions as needed. Business/customer support: Contribute to medical strategies supporting brand commercialization; address informational needs of development customers; foster collaborations with New Product Planning and Health Outcomes; engage external experts and thought leaders; support payer, regulatory advisory activities. Scientific/technical expertise and development: Stay current with medical literature and developments; disseminate knowledge within Lilly; monitor trends in clinical practice and access; pursue extramural scientific opportunities. General responsibilities: Budget support, professional development, training, leadership, and brand representation. Basic Qualifications
Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty; US-trained physicians must have board eligibility/certification. Non-US trained physicians may be hired at the discretion of the Chief Medical Officer. Five years of experience in clinical research or drug development, including large global trials or equivalent qualifying activities; education and training requirements per LCME for non-US graduates. Legal eligibility to work in the United States; Lilly does not typically sponsor work visas for this position. Additional Skills/Preferences
Business acumen and five years of clinical practice with at least 2 years in cardiovascular or renal medicine are preferred. Demonstrated leadership and administrative skills; ability to work within Lilly governance; strong communication, interpersonal, and negotiation skills. Commitment to diversity and inclusion; willingness to engage with payer and health care professionals and to operate in a global regulatory environment. Lilly is an equal opportunity employer. Accommodation requests for the application process can be submitted via the workplace accommodation form. See Lilly’s EEO policy for details on protected statuses and inclusion. Our ERGs support a diverse workforce. Compensation: Actual compensation will depend on education, experience, and location. This role is a full-time position with possible eligibility for a company bonus and comprehensive benefits, including 401(k), pension, health coverage, and other well-being programs.
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