Lilly Clinical Research Physician-Development in Indianapolis, Indiana
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; 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), grant submissions and contracts; 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 the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed.
The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
Core Job Responsibilities
The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds.
The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology 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.
Contribute to business unit and global alignment of clinical strategy and clinical plans.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule
Clinical Research/Trial Execution and Support
Plans, collaborates on and reviews 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.
Provides oversight and input into ICDs
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (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 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 corporate patient safety policies and procedures.
Review IIT proposals and publications, as requested by Director-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.
Prepare or review scientific information in response to customer questions or media requests
Provide telephone follow-up or specific written 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 and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support the design of customer research as medical expert
Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel.
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 (ore and post launch support)
Scientific I Technical Expertise and continued development
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) 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.
Clinical research or pharmaceutical medicine experience preferred
Training in endocrinology preferred
Primary internal interactions
Director(s)-Clinical Operations, managers or project managers
Clinical planning, operations, CRPs/Ss, other research staff
Scientific communication associates
Medical information associates
Global patient outcomes research consultants/research scientists and global patient outcome liaisons
Regulatory directors, scientists, and associates
Product directors, managers, and associates of the brand teams
Sales district managers and sales representatives
Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
Global Marketing director or manager
Corporate patient safety physician
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Regulatory agency personnel
Professional association staff and leaders
Disease advocates and lay organizations focused on relevant health issues
Formulary representatives (private and government)
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Medical Advisor, Product Development - Diabetes
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
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 39,000 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
State / Province: