Lilly

Role Description The Associate Director, GMI is responsible for developing, influencing, and delivering a Global Medical Information strategy in partnership with Global Medical Affairs and other cross-functional partners to support product launches and subsequent line extensions & new indications. The GMI Associate Director will bring the perspective of the customer into the launch strategy by anticipating customer questions, sharing insights around customer experience and satisfaction with the BU and the function, and by implementing key critical initiatives for content generation and dissemination across reactive channels. Responsibilities - Establish relationships within compound and cross-functional teams, across regions and geographies, development phases, and with alliance partners and vendors to resolve medical information strategy for launching molecules. - Understand the voice of the customer based on deep expertise and network within Medical Affairs, then applying that understanding to create a Global Medical Information launch strategy. - Use customer insights to develop Global Medical Information content that improve customer understanding across channels (Digital; Contact Centers). - Ensure unsolicited verbal and written Medical Information inquiries from HCPs and consumers are answered in a timely, accurate, and compliant manner. - Lead the development of comprehensive medical information portfolio training for affiliate, regional, and call center partners that will improve the first customer touchpoint at product launch. - Provide functional coaching and lead ground-breaking initiatives that impact Global Medical Information processes, procedures, and systems. - Develop and maintain expertise in drug information practices across the industry, apply expertise and benchmarking to internal Medical Information discipline. - Provide staffing support and expertise at the Medical Information booth at scientific congresses. Qualifications - Bachelor’s Degree. - Minimum 5 years of medical affairs or medical writing experience. - Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role. Requirements - Master’s Degree with minimum 2 years of medical affairs or medical writing experience. - PhD/PharmD with post-doctoral experience, experience in Oncology, or medical affairs / medical writing experience. - Demonstrated mastery of written English and professional verbal skills in English. - Experience leveraging generative AI for scientific writing. - Strong social skills and the ability to be flexible in varying environments and with multiple customer groups. - Demonstrated ability to lead and influence without authority across all levels in the organization. - Ability to assimilate and communicate large volumes of medical information. - Adaptable to newly emerging technologies. - Demonstrated high-level end-user computer skills. - Ability to engage in travel to a degree appropriate to support the business. - Attention to detail and ability to translate content strategy into realistic implementation plans. - Highly motivated to learn new processes with a quality demeanor. Benefits - Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $187,000. - Full-time equivalent employees also will be eligible for a company bonus. - Lilly offers a comprehensive benefit program to eligible employees, including: - Eligibility to participate in a company-sponsored 401(k); pension. - Vacation benefits. - Eligibility for medical, dental, vision and prescription drug benefits. - Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts). - Life insurance and death benefits. - Certain time off and leave of absence benefits. - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Title: Senior Director - Counsel, Integrated Patient Safety, Regulatory Legal Location: US, Indianapolis IN US: USA Remote time type Full time job requisition id R-105759 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. Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal Organization 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. 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 Senior Director - Counsel, Integrated Patient Safety will be part of the Regulatory Legal Team (RLT), which is a core strategic partner to the business, providing regulatory legal counsel across the product lifecycle from development through registration, commercialization, and post-market activities. RLT is a collaborative team of lawyers who collectively maintain the core legal expertise for the Company on global regulatory laws, including pharmacovigilance, clinical development and registration, manufacturing and quality, environmental and other areas of law. RLT works in close coordination with Business Unit Legal Teams (BULT), International Business Unit Legal (IBU Legal), IP, Litigation and other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while managing legal and regulatory risk. Responsibilities The primary responsibility of this position is to provide strategic, solutions-oriented legal counsel and pharmacovigilance subject matter expertise in support of Lilly’s broad portfolio of products – both in development and marketed. This role will provide strategic counsel to the various pillars of the Global Patient Safety organization, enabling modern pharmacovigilance practices, use of AI to streamline processes, and appropriate governance processes. This role will also partner with colleagues supporting clinical development on matters where patient safety and development activities intersect. This role requires strong judgment and innovative thinking on complex, novel issues while ensuring that Lilly’s pharmacovigilance and clinical development practices are conducted in accordance with applicable laws, regulations, and internal standards. Key responsibilities include: - Pharmacovigilance operations: Serve as the primary legal partner to the pharmacovigilance operations team, providing day-to-day counseling on case management, safety surveillance, safety contracting, vendor oversight, and post-market safety surveillance studies. This requires the ability to translate legal concepts into clear, actionable guidance for business partners operating in a fast-paced, high-volume environment while navigating complex regulatory requirements. - Safety governance: Provide legal advice and support to product level safety management teams, including assessment of emerging safety issues, proposed labeling language, and updates. - Clinical Development Interface: Partner with Regulatory Legal Team and other colleagues on clinical development matters where patient safety considerations intersect, giving pharmacovigilance perspective as needed. - AI/automation enablement: Support AI and automation initiatives across Global Patient Safety and Clinical Development by advising on legal and regulatory considerations (including appropriate governance) and helping develop scalable, fit-for-purpose approaches that enable innovation while handling risk. - PV quality and inspection readiness: Provide legal, regulatory, and GxP compliance counsel on PV Quality matters, including PV risk management, legal support for internal audits, inspection readiness, and response strategy for PV inspections, safety topics related to GCP inspections, and related findings. - Emerging regulatory issues & guidance: Maintain strong awareness of evolving pharmacovigilance and clinical development related laws, regulations, and guidance; translate developments into clear implications, recommendations, and action-oriented guidance for collaborators. - Policy and stakeholder influence: Influence internal and external stakeholders on priority regulatory policy initiatives, in coordination with Global Regulatory Affairs, Policy, and Legal colleagues, to support Lilly’s strategic objectives and protect patient and product integrity. Basic Requirements - Bachelor’s and JD Degrees - Licensed to practice law in one of the US states - Minimum 5-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company - Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Skills/Preferences - Prior regulatory agency experience - Ability to triage, prioritize and effectively counsel a high volume of inputs from a variety of sources - Highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, and members of management across all levels of the Company - Excellent judgment and meticulous level of attention to detail - Excellent written and verbal communication skills with an ability to influence others, including leadership - Proven ability to appropriately handle highly confidential information - Proven dedication to expand knowledge and adapt to a changing, rapid-paced environment - Proven leadership and effectiveness in working with senior leadership - Prior experience advising on pharmacovigilance, drug safety, clinical development, or related regulatory matters - Familiarity with global PV frameworks - Experience advising on AI/automation governance or digital health initiatives Other Information - Remote/hybrid work may be acceptable - No more than 10-15% travel is expected. The role may involve some travel to Lilly’s global affiliates Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any 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 (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $195,000 - $286,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Role Description This role is the accountable leader for global Health Economics and Outcomes Research (HEOR) strategy and execution within the Oncology Business Unit. The M4 owns the HEOR program end-to-end across all OBU assets, partnering with tumor teams, clinical development, market access, commercial, and payer-facing functions to ensure a rigorous, strategically aligned evidence base that supports the clinical and economic value of Lilly oncology medicines. This is a leadership role where the Global Medical Affairs HEOR Lead is expected to make decisions, anticipate risks, drive team performance, and deliver results with urgency. Leadership Expectations - Scientific & Methodological Command: Maintain comprehensive, continuously updated mastery of HEOR methodologies — including patient-reported outcomes (PROs), real-world evidence (RWE) design, cost-effectiveness modeling, burden of illness research, and comparative effectiveness — as applied to oncology. - Program Ownership: Own the HEOR evidence portfolio as a business priority. Anticipate gaps in the evidence base, identify issues before they surface, and drive proactive solutions across tumor teams. - Accountability & Decision-Making: Be accountable for program outcomes by making decisions and clearly identifying HEOR priorities across a complex, multi-asset portfolio. - Strategic Thinking: Connect scientific, economic, and payer landscape insights to shape the HEOR strategy. - Urgency & Delivery: Operate with a bias toward action. Drive timelines, remove obstacles, and deliver HEOR evidence commitments aligned to asset milestones and payer access needs. - Cross-Functional Partnership: Effectively partner with tumor leads, GPLs, clinical development, market access, commercial, and affiliate leaders to integrate HEOR evidence into a single, cohesive asset strategy. - People Leadership: Lead, coach, and develop the HEOR team, setting clear expectations and holding team members accountable for performance, impact, and professional growth. - Team Culture: Create a collaborative, high-performance, inclusive team culture where candid feedback, coaching, and peer learning are the norm. HEOR Strategy & Execution - Own the global HEOR strategy across the OBU portfolio, from early pipeline through lifecycle management. - Develop and maintain a portfolio-level HEOR evidence roadmap that identifies data gaps, prioritizes studies by asset and indication, and aligns to value demonstration milestones. - Facilitate the design, execution, and oversight of HEOR studies including PRO endpoint strategy, health utility studies, indirect treatment comparisons (ITCs), cost-effectiveness models, real-world evidence studies, and burden of illness analyses. - Own the integrated PRO and patient experience strategy for OBU assets. - Oversee real-world evidence strategy and execution in partnership with tumor teams and data science resources. - Provide strategic HEOR input into clinical trial design in collaboration with clinical development. - Own the HEOR-related scientific communication strategy: manuscripts, abstracts, posters, HTA dossier support, and value frameworks. - Manage the HEOR budget and resource allocation across the team. - Maintain fluency in the global HTA landscape including NICE, G-BA, HAS, CADTH, and other key bodies. External Engagement and Scientific Communication - Engage strategically with HEOR thought leaders, outcomes researchers, academic institutions, and payer/HTA stakeholders. - Lead the HEOR external engagement strategy in alignment with tumor teams, market access, and affiliate functions. - Oversee HEOR-related congress strategy, including ISPOR, ASCO, ESMO, ASH, and other relevant venues. - Support payer advisory boards and value evidence review forums in partnership with market access and commercial teams. - Build and maintain a network of HEOR academic collaborators and external experts. Qualifications - Advanced doctoral degree required (PhD, PharmD, MD, or DO). - PhD in health economics, outcomes research, epidemiology, biostatistics, health services research, or a related quantitative discipline is strongly preferred. - 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 at the discretion of the Chief Medical Officer. - Non-U.S.-trained physicians must have completed education and training at a medical school meeting LCME requirements. Requirements - Demonstrated strategic leadership in HEOR, with evidence of portfolio-level program ownership. - Deep expertise in HEOR methodologies — including economic modeling, PROs, RWE design, and HTAs. - Track record of holding teams accountable, coaching for performance, and making difficult decisions. - Ability to influence cross-functionally and create urgency without positional authority. - Strong communication skills — able to translate complex HEOR evidence for executive, commercial, payer, and clinical audiences. - Depth of understanding of the global HTA and payer landscape and its implications for oncology evidence strategy. Benefits - Eligibility to participate in a company-sponsored 401(k); pension. - Vacation benefits. - Eligibility for medical, dental, vision, and prescription drug benefits. - Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts). - Life insurance and death benefits. - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Clinical Research Physician - Ophthalmology locations US: USA Remote time type Full time Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Ophthalmologic Gene Therapy Development Clinical Research Physician (CRP) for LRM participates in the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of ophthalmologic products and other products, as required. This includes participating in: 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, documents and tools supporting product pricing, reimbursement, and access (PRA); contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for all relevant products, including various medical activities in support of demand realization. The CRP serves as a scientific and medical resource with specific expertise in ophthalmology for study teams, departments, and others as needed. Primary Responsibilities Clinical Planning - Understand and keep updated with the pre-clinical and clinical data relevant to the product(s). - Contribute to business unit and global alignment of clinical strategy and clinical plans. - Collaborate with the appropriate LRM leaders in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer): the product lifecycle plan, clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support - Plan, collaborate on, and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline. - Provide oversight and input into integrated clinical development plans (ICDs) - Collaborate with clinical research staff in the design, conduct and reporting of clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). - Review and approves risk profiles to ensure appropriate communication of risk to study subjects. - Participate in investigator identification and selection for the purposes of clinical trials, in conjunction with clinical teams, and in center of excellence identification to the extent relevant to the commercial model. - Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. - 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 to address any questions or clarify issues arising during the conduct of study. - Understand and actively addresses the scientific information needs of all investigators and personnel. - Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. - Review IIT proposals and publications, as requested by Director-Clinical/Medical. Scientific Data Dissemination/Exchange - 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. - Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. - 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. - Support medical information associates in preparation and review of medical letters and other medical information materials. - Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). - Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis. - Steward appropriate collaborations and relationships between Lilly and relevant professional societies. - Support the design of stakeholder (e.g., patient, HCP, payer) research as medical expert - Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events) - 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 label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. - Provide medical expertise to regulatory scientists. - Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. - Participate in advisory committees. - Participate in risk management planning along with affiliates and Global Patient Safety (GPS). Business/ customer support (pre and post launch support) - Contribute to the development and, where appropriate, execution of medical strategies to support brand commercialization activities by working closely with LRM leadership, brand teams, clinical plans personnel and other cross-functional management during the development of the global and local business plan(s). - Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers, policymakers). - Actively address Development customer (payer, patient, health care providers, and policymaker) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. - Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. - Contribute as a scientific and medical expert to activities and deliverables of the commercial organization, including giving clinical input and insight to develop PRA strategies and partnerships to demonstrate a product’s value. - Contribute actively on an ongoing basis to the strategic planning for the brand. - By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed. - Become familiar with market archetypes and potential influence on the medical interventions for the product. - Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert. Scientific / Technical Expertise and continued development - Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. - Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product(s), both near term (1-2 years) and longer term (3-5 years). - Responsible for the scientific training of the clinical study team. - Acts as scientific consultant and protocol expert for clinical study team members and others in medical. - Explore and take advantage of opportunities for extramural scientific experiences. - Attend scientific symposia. Minimum Qualifications - Medical Doctor. 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). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC - Board-eligibility or certification in ophthalmology Additional Preferences: - At least 5 years clinical research or pharmaceutical medicine experience desirable, particularly in the setting of a biotechnology company - Demonstrated knowledge of drug development process - Fluent in English; both written and verbal communications - Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills - Demonstrated ability to influence others (both cross-functionally and within the function) 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 Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $389,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Executive Director Early Development Clinical Research Physician - Neuroscience locations US, Remote time type Full time 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 neuroscience 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 clinical lead to progress multiple early clinical assets into first-in-human studies and 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, contacts 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 PLA: Medical Licensing Information and Medical Education | MBC - 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. - At least five (5) years of pharmaceutical industry, research, or clinical experience, 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). Additional Skills/Preferences - Pharmaceutical company experience preferable. - Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research preferable. - Broad experience in Clinical Pharmacology preferable. - Experience with genetic therapy modalities (e.g., siRNA, ASO, gene therapy) 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 Practices (GCPs) and local laws and requirements. - 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 trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. - Understand and actively address the scientific information needs of all investigators and personnel. - Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures. - Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety. - Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution. Scientific Data Dissemination/Exchange - 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/customers. - Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above. - Participate in reporting of clinical trial data in Clinical Trial Registry activities. - Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process. - Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies. - Publish results of research projects as appropriate. - Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects. - Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. - Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials. - Provide clinical reports for local and international regulatory purposes. Regulatory Support Activities - Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response. People Management and Development: - Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience. - Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness. - Develop an organizational talent base that demonstrates judgment-based risk taking and decision making. Business customer support (pre and post launch support) - 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 (business unit, payers, patients, health care providers). - Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. - Support business-to-business and business-to-government activities as medical expert. - Contribute actively on an ongoing basis to the strategic planning for the brand. - Become familiar with market archetypes and potential influence on the medical interventions for the product. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $219,000 - $389,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Role Description We are currently hiring for two National Medical Education Manager roles. The Therapeutic Areas will be Immunology & Cardiometabolic Health focused. The National Medical Education Manager at Eli Lilly Canada Inc. is responsible for strategically planning, developing, and executing medical education initiatives across Canada to support the appropriate and effective use of Lilly medicines and therapies. This role ensures all educational activities align with scientific imperatives, company strategies, and regulatory guidelines. This position is a remote opportunity and National in scope. Applicants are eligible to apply from anywhere in Canada. At Lilly Canada, we have three levels for this position based on the candidate’s experience, background, and qualifications. The expected compensation is: - Level 1: $67,500 – $99,000 - Level 2: $83,250 – $122,100 - Level 3: $111,750 - $163,900 This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program and company car. Job Responsibilities - Develop and implement comprehensive national medical education plans aligned with brand strategies, medical affairs objectives, and therapeutic area priorities. - Identify educational gaps and unmet needs within the healthcare professional community through market insights, scientific literature review, and collaboration with internal and external stakeholders. - Design, develop, and deliver high-quality scientific and medical educational programs, including symposia, speaker tours, enduring materials, and digital learning platforms. - Manage relationships with key opinion leaders (KOLs), medical societies, and other external partners to ensure credible and impactful educational content. - Collaborate cross-functionally with Medical Affairs, Marketing, Regulatory, Legal, and Compliance teams to ensure all medical education activities are compliant, scientifically accurate, and strategically relevant. - Oversee the budget and resources allocated for national medical education initiatives, ensuring efficient and effective utilization. - Evaluate the effectiveness of educational programs through defined metrics and feedback mechanisms, making continuous improvements as needed. - Stay abreast of evolving scientific data, clinical guidelines, and regulatory requirements relevant to Lilly's therapeutic areas. - Represent Eli Lilly Canada Inc. at national and international scientific conferences and meetings, engaging with healthcare professionals and gathering insights. Qualifications - Advanced degree in a scientific or healthcare-related field. - Minimum of 5 years of experience in medical affairs, medical education, or a related role within the pharmaceutical or biotechnology industry. - Demonstrated expertise in designing, developing, and executing medical education programs for healthcare professionals. - Strong understanding of the Canadian healthcare landscape, regulatory environment, and industry codes of conduct (e.g., Innovative Medicines Canada). - Excellent communication, presentation, and interpersonal skills, with the ability to effectively engage and influence diverse audiences. - Proven ability to work collaboratively in a cross-functional team environment. - Strong project management skills, including budget management and vendor oversight. - Strategic thinking and analytical skills, with the ability to translate scientific information into actionable educational initiatives. - Proficiency in English and French (oral and written) is strongly preferred. - Ability to travel nationally and occasionally internationally as required. Benefits - Eligibility to participate in a pension plan. - Vacation benefits. - Eligibility for healthcare benefits. - Flexible benefits (if applicable). - Life insurance and death benefits. - Certain time off and leave of absence benefits. - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Title: Sr. Principal Security Engineer, Application Security & Automation Location: Remote United States Full time Job Description: 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. As an Application Security Engineer your role is focused on advancing Lilly's Secure SDLC program through engineering, automation, and applied AI. This is a critical, builder role on the Security Architecture & Engineering (SAE) team that will own and evolve core AppSec platforms- SAST, DAST, SCA, secret scanning, secrets management, and software supply chain controls- while building the automation and AI tooling that can scale across thousands of repositories and hundreds of applications. We're targeting candidates at R4-6. Job description is below. What You'll Be Doing: As an Application Security Engineer, you will operate at the intersection of software engineering and security engineering- leading platforms, writing code, building integrations, and designing automation. You will take part in Lilly's Secure SDLC program end-to-end, including SAST, DAST, SCA, and secret scanning tooling; secrets management; and our emerging software supply chain capabilities. You will use technology and apply LLM-based approaches to secure application and architecture design, vulnerability triage and remediation, and the delivery of secure‑by‑default patterns across Lilly's development ecosystem. How You'll Succeed: - Engineering-first mentality: You bring real software development experience and treat security problems as engineering problems, automating what can be automated, integrating deeply with developer workflows, and writing production-quality code. - AI fluency: You are genuinely excited about LLMs and agentic tooling and have built things with them. You understand MCP, agent harnesses, and how to wire LLMs into real workflows - and you can tell where AI meaningfully accelerates security work versus where it shouldn't be trusted. - Platform management: Success requires running AppSec tooling as platforms with clear SLAs, telemetry, and continuous improvement rather than one-off scans and tickets. - Secure coding credibility: You have written code in multiple languages and ecosystems and can speak the developer's language. When you flag a finding or propose a control, engineers trust that you understand the tradeoffs. - Developer partnership: You build leverage through partnership-meeting development teams where they are, shipping secure-by-default patterns, and making the secure path the path of the least resistance. - Build system security: You understand that CI/CD is itself a high-value target. You have opinions on GitHub Actions OIDC, pinning actions to commit SHAs, least-privilege runners, and protecting secrets and artifacts as they move through the pipeline. Key Responsibilities: - Evolve one or more AppSec platforms within the Secure SDLC program. - Design and build automation within Security Architecture and Engineering. - Apply LLMs, agentic frameworks, MCP servers, and tool-calling patterns. - Partner with development teams on secure coding practices, threat modeling, and remediation of findings from SAST, DAST, SCA, and secret scanning tools. - Contribute to Lilly's Secure SDLC standards and vulnerability management policy, translating policy into enforceable pipeline and platform controls. - Support the secrets management rollout and migration of applications off legacy secret stores, including code-level guidance for SDK-based and injected consumption patterns. - Produce developer-facing content, reference architectures, secure patterns, short-form instructional content and reusable code samples. - Harden Lilly's CI/CD environment against software supply chain attacks- pinned actions, OIDC-based cloud auth, runner isolation, workflow permissions, and protection of build-time secrets and artifacts. - Partner with the Cloud Security team on Infrastructure-as-Code (IaC) security - extending secure-by-default patterns and developer guardrails from application code into the infrastructure that runs it. Your Basic Qualifications: - Bachelor's Degree in Computer Science, Information Security, Software Engineering, or related fields. - At least 2 years of dedicated application security experience - At least 2 years of software development experience with individual contributions to production systems, - At least a total of 5 years of combined experience across both rigors. - Demonstrated production coding experience in at least one of: Python, TypeScript/JavaScript, Java, Go, or C# - not solely in an advisory, review, or scripting capacity. - Experience building or integrating security automation within a GitHub environment, including GitHub Actions. - Familiarity with threat modeling in a professional setting - Hands-on experience with large language models (LLMs) in a professional or project context, such as prompt engineering, API integration, or workflow automation. What You Should Bring: - Hands-on software development experience in at least one modern language (Python, TypeScript/JavaScript, Java, Go, or C#) with a track record of shipping working code- not just reviewing others'. - Strong expertise in application security fundamentals-OWASP Top 10, CWE, secure coding practices, threat modeling, and vulnerability assessment. - Experience operating or deeply integrating with SAST, DAST, SCA, and secret scanning tools. - Genuine enthusiasm for and hands-on experience with LLMs, prompt engineering, agentic workflows, or LLM-powered tooling-bonus points for things you have actually built and shipped. - Familiarity with secrets management platforms and patterns and with software supply chain / artifact management. - Working knowledge of cloud environments (AWS preferred; Azure or GCP welcome) and containerized workloads (ECS, EKS, Docker). - Familiarity with IaC scanning and the IaC ecosystem (Terraform, CloudFormation, Kubernetes manifests) - Strong communication skills; ability to translate security requirements into actionable engineering guidance and to represent AppSec in conversations with engineering partners. - Commitment to staying ahead of with emerging AppSec threats, tooling, and AI/LLM capabilities. Location & Work Flexibility This role is based at our Corporate Center in Indianapolis, IN. We offer a flexible hybrid work model, with three days onsite and two days working remotely each week, supporting both collaboration and work‑life balance. We are also open to considering fully remote candidates based on role requirements and business needs. 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 (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Role Description The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering and Continuous Improvement delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain. - Project Management: Lead teams to deliver large programs of at least $50M USD or more in capital assets and/or support a workstream or node of a larger program of $200M or more in capital assets. These teams will consist of both Lilly and Non-Lilly professionals to safely achieve project objectives from front-end planning (conceptual design) in a Brownfield or Greenfield site through operational qualification (cradle to grave). Project objectives are defined as delivering asset capability or capacity with safety, cost, schedule, and quality assurance. - Interface/Communication: Ability to work from a regional distance from corporate headquarters while developing and maintaining effective communication with GFD program leadership, the project team, governance teams, business partners, and other stakeholders. Facilitate issue resolution, anticipate scope changes, and implement safely with quality, speed, and value. - Compliance: Lead/influence with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures. - Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification. Qualifications - Bachelor of Science – Engineering field or related to project management - Minimum 5+ Years of previous experience in capital project delivery in industrial or manufacturing facilities. - Previous experience managing greenfield projects. - Project Size: Previous experience on projects or multiple projects of >$10M. Requirements - Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Preferences - Pharma manufacturing experience. - Capital Project Management Experience in Pharma manufacturing facilities, such as: Bulk API, sterile products, secondary packaging, Devices and to a lesser extent lab projects. - Experience in the following areas: GMP manufacturing, LEAN, Automation, construction, construction quality, project controls, the engineering disciplines, safety, scheduling. - The capacity to achieve results and influence through people is critical. - Demonstrated ability to work from long distances with little supervision. - Must exhibit a good sense of judgment in decision making, without the need for management approval while at the same time keeping management informed and engaged on critical issues. - Effective communication skills both written and verbal. - Ability to influence personnel and organizations without having direct administrative responsibility for them. - Competency in a foreign language(s). - Professional Engineer (PE) or equivalent technical certification. - Project Management Professional (PMP) certification. - Experience in working and/or living outside the U.S. - Demonstrated willingness to embrace the concept of continuous improvement and be an agent for change. Benefits - Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. - Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). - Lilly offers a comprehensive benefit program to eligible employees, including: - Eligibility to participate in a company-sponsored 401(k); pension; - Vacation benefits; - Eligibility for medical, dental, vision and prescription drug benefits; - Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); - Life insurance and death benefits; - Certain time off and leave of absence benefits; - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). - Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Role Description We are looking for an RNAi drug discovery expert with deep experience in oligonucleotide chemistry, molecular biology, pharmacology, and delivery technologies. This individual will be responsible for the critical evaluation of scientific and business opportunities, design and execution of novel RNAi therapeutics within ExploR&D, and partnership with Lilly Genetic Medicines LGM to ensure strategic alignment and maximum impact. This leader combines scientific rigor and expertise, innovative thinking, demonstrated learning agility and execution, and collaborative leadership to advance RNAi innovation from concept to scalable capability. Key Responsibilities - Scientific Evaluation & Project Execution - Collaborate with external partners to critically evaluate opportunities for RNAi innovation, including scientific merit and technical feasibility. - Design and execute RNAi discovery projects with robust experimental design, fit-for-purpose methodologies, and clear success criteria. - Lead and consult regarding siRNA/ASO candidate screening, hit identification, and lead optimization using cellular and molecular biology methodologies (e.g., mammalian cell culture, in vitro screening, cell-based assays, PCR). - Oversee in vivo drug candidate testing with ATP partners, including experimental design for animal studies, dose planning and sample analysis. - Strategic Alignment & Portfolio Management - Work with leadership to translate scientific and portfolio needs into an RNAi innovation roadmap aligned with area strategies, best practices and joint initiatives. - Prioritize opportunities that impact molecule quality, cycle time, and probability of technical success. - Innovation Scouting & Technology Integration - Systematically scan internal and external landscapes for RNAi innovation and build scientific cases for licensing. - Coordinate pilot execution across internal and external partners with fit-for-purpose experimental design and robust success factors. - Partner with discovery operations, digital/IT, procurement, and finance to transition successful pilots into routine capabilities. - Due Diligence & Partnership Management - Lead and participate in due diligence of early-stage RNAi technology partners, including scientific assessments, pilot plans, and integration pathways. - Manage external biotech and CRO relationships to ensure quality delivery and strategic alignment. - Build workplans, execute, and maintain productive partnerships with biotech collaborators and technology providers. - External Representation - Represent Lilly in external meetings and conferences, showcasing internal RNAi innovation and scouting new opportunities. - Serve as scientific ambassador for ExploR&D's RNAi capabilities. Qualifications - PhD or Master’s in Chemistry or related field. - 7+ years of oligonucleotide chemistry, lead optimization and design experience. - 10+ years of drug discovery experience. - 3 patents or patent applications demonstrating scientific leadership in oligonucleotide therapeutics. Requirements - Proven track record managing cross-functional teams and projects. - Experience managing external CRO relationships and resources related to oligonucleotide research. - Deep understanding of RNAi mechanisms, delivery technologies, pharmacology, and drug development processes. - Strong leadership abilities, strategic thinking, and entrepreneurial mindset. - Excellent communication and interpersonal skills with ability to influence across organizations. - Experience with RNAi screening technologies, sequence selection, human-relevant pharmacology models, purification and formulation best practices and automation platforms. - Knowledge in area of oligonucleotide relevant tissue delivery and conjugation chemistry. - Knowledge of therapeutic areas relevant to RNAi medicines. - Proven track record of successful collaboration within drug discovery organizations. - Strong analytical and problem-solving skills. - Experience in biotech partnership models or early-stage drug discovery environments. Benefits - Eligibility to participate in a company-sponsored 401(k); pension. - Vacation benefits. - Eligibility for medical, dental, vision and prescription drug benefits. - Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts). - Life insurance and death benefits. - Certain time off and leave of absence benefits. - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Role Description The Clinical eDC Study Build Programmer is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Responsibilities: - Portfolio Delivery: - Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components. - Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives. - Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets). - Support submission, inspection and regulatory response activities. - Lead cross Business Unit/Therapeutic Area projects or programs with high complexity. - Opportunity to develop and test new ideas and/or apply innovative solutions that add new value to the portfolio. - Project Management: - Increase speed, accuracy, and consistency in the development of systems solutions. - Enable metrics reporting of study development timelines and pre and postproduction changes to database. - Partner to deliver study database per business need and before first patient visit. - Follow and influence data standard decisions and strategies for a study and/or program. - Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data. - Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables. - Integrate multi-functional and/or external information and apply technical knowledge to data-driven decision making. - Enterprise Leadership: - Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository. - Represent Data and Analytics processes in multi-functional initiatives. - Actively engage in shared learning across the organization. - Work to increase re-usability of forms and edits by improving the initial design. - Work to reduce postproduction changes change control process. - Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization. - Interact with regulators, business partners and outside stakeholders on business issues. - Think with end to end in mind consistently managing risk to minimize impact on delivery. - Build a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development. - Focus on defining database solutions and timelines in support of advancing the portfolio. - Other Responsibilities: - Provide coaching and guidance for junior Clinical Study Build Programmers. - May or may not lead a team of junior Clinical Study Build Programmers. - Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable workforce. - Provide effective technical leadership to an agile team of technical staff. - Create a team culture that fosters inclusion and innovation and values diversity. - Responsible for effective resource planning and supervising clinical study build programmer staff. - Ensure all necessary training is provided to staff to support job performance and knowledge. Qualifications - Master’s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Information Technology, Computer Sciences (or bachelor’s degree plus 5 or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors). - At least 3 years of eDC Study Build Programming experience. - 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. Requirements - Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc. - Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc. - Knowledge of CDISC and CDASH standards/standard terminology. - The ability to work independently as well as in a team environment. - Project and Vendor management experience. - Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment. - Demonstrated ability to stay abreast of trends and new information in the profession. - Quick learner to new trends in technology. - Excellent leadership, communication (written and oral) and interpersonal skills. - Demonstrated teamwork and collaboration in a professional setting. - Experience with articulating the flow of data (structure and format) from patient to analysis. - Deciding the technology platform (system/database) for data acquisition and aggregation. - Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members. - Strong therapeutic/scientific knowledge in the field of research. - Society of Clinical Data Management certification. - Project management experience. - Familiarity with clinical data tools and technologies. - Understanding and experience in using data standards. - Ability to balance multiple activities, prioritize and manage ambiguity. - Demonstrated exemplary teamwork/interpersonal skills. - Proven problem solving, attention to detail and result-oriented behaviors in a fast-paced environment. Benefits - Full-time equivalent employees will be eligible for a company bonus (depending, in part, on company and individual performance). - Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits. - Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts). - Life insurance and death benefits. - Certain time off and leave of absence benefits. - Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Company Description Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.