Clinical Research Scientist, Immunology - Lilly BioMedicines
Through the application of scientific training and clinical training and expertise, the Development Clinical Research Scientist 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 clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance (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.
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds.
- 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 (e.g., annual reports) according to the agreed upon project timeline.
- Provide protocol oversight and input into informed consent documents.
- Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
- 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 collaborates with CRP on the approval of 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/CTMs/ 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.
- Review lIT proposals and publications, as requested by CRP or 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 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.
- 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.
- 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.
- Support the design of customer research as medical expert
- 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).
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support training of medical personnel, including geographic/affiliate medical personnel as assigned, 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 I 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).
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.
- An advanced health/medical/scientific or related graduate degree such as PharmD, PhD, PA, MSN with advanced clinical specialty
- Bachelor's or Master's degree considered if paired with:
- 3-5 years of clinical/pharmaceutical experience or
- 7-10 years Drug/Clinical trial, Discovery & Development experience
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.
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills.
- Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills.
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Experience working with delivery devices and Human Factors studies.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
- Fluent in English, verbal and written communication.