Job Detail
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Career Level Others
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Experience 2 Years
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Qualifications Master’s Degree
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 35,000 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.
The Clinical Research Scientist (CRS) will support clinical programs within neurodegeneration therapeutic area (LRL), and report to the Senior Medical Director, Clinical Head of Neurodegeneration.
Responsibilities :
The primary responsibilities of the CRS will primarily relate to early-phase compounds, but may also include compounds in later stages of clinical development as needed. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
- CRS will be involved in development of the overall strategy and clinical plan for development of clinical compounds, including preparation of high-level plan for phase I, II and Ill studies; collaboration with local clinical research staff, consultants and clinical investigator’s in the design, conduct and reporting of global Phase I, II and III clinical trials (e.g., sample size, patient dedication, timelines, grants, and governance review interactions).
- CRS will also collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development with disease-progression and drug-disease response models.
- CRS will work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, collaborate with non-clinical pharmacologists to translate observations from pre-clinical experiments to human clinical studies (biomarker development) in the therapeutic area of responsibility.
- CRS will participate in designing and writing study protocols, participate in investigator identification and selection (in conjunction with clinical team); review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects.
- CRS will help ensure that operational team has detailed 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, and 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.
- CRS will serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. CRS will be required to understand and actively address the scientific information needs of all investigators and personnel; monitor (in conjunction with Global Patient Safety group) 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.
- CRS will be required to critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and stay up to date with medical and scientific developments relevant to the therapeutic area. Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects will be required.
- CRS will also explore and take advantage of opportunities for extramural scientific experiences, and attend scientific symposia.
Basic Requirements:
- An advanced scientific/medical graduate degree such as PharmD, DVM, PhD, or MD is required (PhD preferred).
- Minimum of 2 years of pharmaceutical / clinical drug development experience.
Additional Skills/Preferences:
- Neuroscience experience strongly preferred.
- 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 build a positive working environment.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (up to 10% travel).
- Proficient in English, verbal and written communication.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.