Eli Lilly and
Senior Director Global Medical Affairs (Cardiovascular/Cardiometabolic Health)
Eli Lilly and, 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 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 are looking for people who are determined to make life better for people around the world. Purpose:
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Cardiovascular/Cardiometabolic Business Unit – Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is an integral member of the medical affairs team for strategic planning in support of launch and commercialization activities to meet patients’ needs and enhance the customers’ experience in interacting with the company. The definition of “customer” includes patients, providers (HCPs) and payers. The Senior/Executive Director may work with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development across the drug development spectrum and clinical trial phases. Specific activities include developing or contributing to the global and/or regional clinical/medical plan, the development, conduct and reporting of clinical trials; implementation of global clinical trials conducted in local affiliates/countries; reporting adverse events; review processes for protocols, study reports, publications and data dissemination; updates to labels, documents and tools supporting product pricing, reimbursement and access (PRA); grants submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities with the external clinical customer community (thought leaders); and various medical activities in support of demand realization. The Senior/Executive Director serves as a scientific resource for study teams and others as needed. They ensure all activities of the medical team are in compliance with current local and international regulations, laws, guidance (FDA, ICH, CPMP, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and global quality standards, aligned with the medical vision. Primary Responsibilities
The primary responsibility is to provide expert medical support to all aspects of the local/global business to enhance the customers’ experience with the company. This includes marketed product support (development of the patient journey and strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies, medical support for pricing, reimbursement and access (PRA), and leading in scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of scientific content for educational programs). Responsibilities relate to late-phase and marketed compounds and may include early-phase trials. The Senior/Executive Director is responsible for planning, startup and conduct of phase 3b/4 studies, and nonclinical trial activities conducted in global teams and affiliates. With portfolio expansion, this role provides scientific support for incretins family within the portfolio across the spectrum of patients with obesity, including design and execution of phase 3b/4 studies and expansion of real-world evidence and patient-reported outcomes to address commercial needs. Business/customer support (pre and post launch support) Support planning of symposia, advisory board meetings, and facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations with external scientific experts, thought leaders, and the medical community at local, national, regional and international levels. Develop and maintain collaborations with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (e.g., answering questions at exhibits, presenting oral/poster presentations, staffing medical booths, meeting thought leaders, and participating in customer events). Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in protocol development and data collection requirements. Participate in investigator identification and selection with clinical teams. Ensure clinical operations teams have documented completion of administrative requirements for study initiation and conduct per GCPs and local laws. Assist in the planning process and participate in study start-up meetings to provide scientific training and information to investigators and site personnel. Serve as a resource to clinical research site monitors, investigators and ethical review boards to address questions during study conduct. Review IIT proposals and publications as requested; contribute to global alignment of Phase 3b/4 studies (and Phase I/II where applicable) planned by country or global Development team. Understand and address scientific information needs of investigators and personnel. Monitor patient safety during studies and track adverse events in line with corporate patient safety policies. Regulatory Support Activities Be aware of current trends and projections for clinical practice and access in relevant therapeutic areas (near term and longer term). Critically read and evaluate relevant medical literature; know the status of data from competitive products; stay updated with medical developments relevant to the product. Responsible for scientific training of the clinical study team. Act as scientific consultant and protocol expert for clinical study team members and others in medical. Explore opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Be an ambassador for patients and the Lilly Brand. Essential skills include deep understanding of cardiovascular pathophysiology, clinical management, medical affairs (including medical planning for launch), data dissemination and communication across early-phase data, clinical data, and observational research to enable use of real-world evidence to support provider, patient, policy and payer needs. Minimum Qualification Requirements: Medical Doctor or Doctor of Osteopathy. Board eligible or certified in appropriate specialty/subspecialty or equivalent post-medical school training applicable to hiring country. US-trained physicians must have board eligibility or certification. Physicians trained outside the US may be hired at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed medical education at schools that meet LCME requirements. See the list of foreign medical schools at the referenced government site for details. Minimum 2 years of clinical experience in cardiovascular medicine Preferences: Cardiology board eligible or certified preferred Prior pharmaceutical industry experience in medical affairs or clinical development preferred Knowledge of drug development process preferred Ability to balance scientific priorities with business priorities and influence others to create a positive working environment Ability to engage in domestic and international travel as needed Strong leadership, communication, teamwork, organizational, and negotiation skills Fluent in English, verbal and written Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If accommodation is required to submit a resume, please complete the accommodation request form. This is for accommodation requests as part of the application process; other correspondence will not receive a response. 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, and Women’s Initiative for Leading at Lilly. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $198,000 - $356,400. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program, including 401(k), pension, health benefits, flexible benefits, life insurance, paid time off, and well-being programs. Lilly reserves the right to amend compensation and benefits 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 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 are looking for people who are determined to make life better for people around the world. Purpose:
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Cardiovascular/Cardiometabolic Business Unit – Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is an integral member of the medical affairs team for strategic planning in support of launch and commercialization activities to meet patients’ needs and enhance the customers’ experience in interacting with the company. The definition of “customer” includes patients, providers (HCPs) and payers. The Senior/Executive Director may work with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development across the drug development spectrum and clinical trial phases. Specific activities include developing or contributing to the global and/or regional clinical/medical plan, the development, conduct and reporting of clinical trials; implementation of global clinical trials conducted in local affiliates/countries; reporting adverse events; review processes for protocols, study reports, publications and data dissemination; updates to labels, documents and tools supporting product pricing, reimbursement and access (PRA); grants submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities with the external clinical customer community (thought leaders); and various medical activities in support of demand realization. The Senior/Executive Director serves as a scientific resource for study teams and others as needed. They ensure all activities of the medical team are in compliance with current local and international regulations, laws, guidance (FDA, ICH, CPMP, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and global quality standards, aligned with the medical vision. Primary Responsibilities
The primary responsibility is to provide expert medical support to all aspects of the local/global business to enhance the customers’ experience with the company. This includes marketed product support (development of the patient journey and strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies, medical support for pricing, reimbursement and access (PRA), and leading in scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of scientific content for educational programs). Responsibilities relate to late-phase and marketed compounds and may include early-phase trials. The Senior/Executive Director is responsible for planning, startup and conduct of phase 3b/4 studies, and nonclinical trial activities conducted in global teams and affiliates. With portfolio expansion, this role provides scientific support for incretins family within the portfolio across the spectrum of patients with obesity, including design and execution of phase 3b/4 studies and expansion of real-world evidence and patient-reported outcomes to address commercial needs. Business/customer support (pre and post launch support) Support planning of symposia, advisory board meetings, and facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations with external scientific experts, thought leaders, and the medical community at local, national, regional and international levels. Develop and maintain collaborations with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (e.g., answering questions at exhibits, presenting oral/poster presentations, staffing medical booths, meeting thought leaders, and participating in customer events). Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in protocol development and data collection requirements. Participate in investigator identification and selection with clinical teams. Ensure clinical operations teams have documented completion of administrative requirements for study initiation and conduct per GCPs and local laws. Assist in the planning process and participate in study start-up meetings to provide scientific training and information to investigators and site personnel. Serve as a resource to clinical research site monitors, investigators and ethical review boards to address questions during study conduct. Review IIT proposals and publications as requested; contribute to global alignment of Phase 3b/4 studies (and Phase I/II where applicable) planned by country or global Development team. Understand and address scientific information needs of investigators and personnel. Monitor patient safety during studies and track adverse events in line with corporate patient safety policies. Regulatory Support Activities Be aware of current trends and projections for clinical practice and access in relevant therapeutic areas (near term and longer term). Critically read and evaluate relevant medical literature; know the status of data from competitive products; stay updated with medical developments relevant to the product. Responsible for scientific training of the clinical study team. Act as scientific consultant and protocol expert for clinical study team members and others in medical. Explore opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Be an ambassador for patients and the Lilly Brand. Essential skills include deep understanding of cardiovascular pathophysiology, clinical management, medical affairs (including medical planning for launch), data dissemination and communication across early-phase data, clinical data, and observational research to enable use of real-world evidence to support provider, patient, policy and payer needs. Minimum Qualification Requirements: Medical Doctor or Doctor of Osteopathy. Board eligible or certified in appropriate specialty/subspecialty or equivalent post-medical school training applicable to hiring country. US-trained physicians must have board eligibility or certification. Physicians trained outside the US may be hired at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed medical education at schools that meet LCME requirements. See the list of foreign medical schools at the referenced government site for details. Minimum 2 years of clinical experience in cardiovascular medicine Preferences: Cardiology board eligible or certified preferred Prior pharmaceutical industry experience in medical affairs or clinical development preferred Knowledge of drug development process preferred Ability to balance scientific priorities with business priorities and influence others to create a positive working environment Ability to engage in domestic and international travel as needed Strong leadership, communication, teamwork, organizational, and negotiation skills Fluent in English, verbal and written Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If accommodation is required to submit a resume, please complete the accommodation request form. This is for accommodation requests as part of the application process; other correspondence will not receive a response. 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, and Women’s Initiative for Leading at Lilly. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $198,000 - $356,400. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program, including 401(k), pension, health benefits, flexible benefits, life insurance, paid time off, and well-being programs. Lilly reserves the right to amend compensation and benefits programs at its discretion. #WeAreLilly
#J-18808-Ljbffr