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.
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
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
$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.
