Clinical Research Scientist
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 10, 2025
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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. Organization Overview: The
Diabetes, Obesity & Complications Program Phase Clinical Research
Scientist (CRS) participates in the following for compounds of
responsibility for the therapeutic area, including an evolving
portfolio of compounds targeting chronic weight management and
diabetes mellitus: 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; assessment of licensing
opportunities, and the outreach activities aimed at the external
clinical customer community. In addition, the Clinical Research
Scientist works with research scientists to identify lead compounds
and clinical candidates and plan pre-clinical studies. Core tasks
will be delegated based on level of experience. Other activities
include internal training activities, peer-review of clinical
protocols and reports, and ad hoc scientific consultation within
Lilly. The CRS works with late stage development colleagues to plan
for meeting patient needs through clinical studies, and outcomes
and pharmacoeconomic research. The Program Phase CRS 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. Primary Responsibilities : The primary responsibilities of
the Diabetes, Obesity & Complications Program Phase CRS are
generally related to early-phase compounds, including those
targeting chronic weight management and diabetes mellitus. 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 early phase clinical plan for development of
clinical compounds, focusing on studies required for strategic
decisions. Collaborate with local clinical research staff,
consultants and clinical investigators in the design, conduct and
reporting of global Phase lb and Ila/IIb clinical trials (e.g.,
sample size, patient commitment, timelines, grants, and governance
review interactions). 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.
Work closely with discovery research scientists in the development
of basic research strategies, clinical candidate compound
selection, and pre-clinical development. Collaborate with
non-clinical pharmacologists to translate observations from animal
experiments to human clinical studies (biomarker development) in
the area therapeutic area of responsibility. Collaborate with drug
disposition scientist to conduct pharmacokinetic and drug
metabolism studies of drug candidates in humans. Assist
pharmacokineticists and statisticians by providing clinical support
to the development of pharmacostatistical models of drug exposure
and response (PK/PD modeling and trial stimulation) to optimize
dosing regimens and selection of the target patient population.
Clinical Research/Trial Execution and Support Design and oversee
implementation of Phase lb and Ila/IIb clinical studies. Design and
write clinical trial protocols. Design and oversee implementation
methods for development and biomarker qualification studies.
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 clinical team. Interact with
consultants and clinical investigators to plan, initiate, and
conduct worldwide clinical trials (Phase I and II). Review and
approve risk profiles, and local informed consent documents as
required, to ensure appropriate communication of risk to study
subjects. Ensure 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 CDAs I 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. 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. 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. 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. Support development
of slide sets and publications (abstracts, posters, manuscripts).
Support the creation and review of any scientific information with
respect to customer questions or media request in accordance with
global compliance policies and procedures. Provide congress support
(e.g., availability to answer questions at exhibits, provide oral
and poster presentations, staff medical booth, meet thought
leaders, and participate in customer events). Regulatory Support
Activities Support/ 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. Develop and
review labeling modifications in collaboration with regulatory and
safety groups. Participate in risk management planning along with
GPS colleagues. Provide medical expertise to regulatory scientists.
Business/ customer support Understand the scientific/medical needs
of all Diabetes Obesity & Complications Program Phase customers
(payers, patients, health care providers Provide advice and
consultation to global business unit with regard to potential
markets for development compounds and in-licensed projects or
compounds. Support business development in collaboration with the
regulatory and corporate affairs group. Establish and maintain
appropriate collaborations and relationships with external experts,
thought leaders, and the general medical community on a national
and possibly international basis. Participate in PhRMA or other
local or national trade associations. Develop and maintain
appropriate collaborations and relationships with relevant
professional societies. Participate in patent development. 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
in medical field of interest; and keep updated with medical and
other scientific developments relevant to the therapeutic area.
Provide consultation to health outcomes staff, marketing
professionals, and management regarding the potential medical need
served by responsible therapeutic area drug candidates. Knowledge
of current trends and projections for clinical practice and access
in the therapeutic area(s) relevant to the development projects.
Explore and take advantage of opportunities for extramural
scientific experiences. Attend scientific symposia. Understand and
keep updated with the pre-clinical, clinical pharmacology and
clinical data relevant to the molecule. Maintain awareness of
current clinical practices through experience or contacts. General
Responsibilities Actively set and meet individual professional
development goals and contribute to the development of others by
being an active source of coaching and feedback to co-workers.
Actively participate in recruitment, diversity, and retention
efforts. Participate in committees, initiatives and task forces as
requested by local/corporate management. Model leadership behaviors
and lead matrixed cross-functional teams. Basic Qualifications An
Advanced Health/Medical/Scientific degree (For Example, In
Pharmacology, Physiology, Microbiology) or related Graduate degree
such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty
(Clinical Nurse Specialist/Nurse Practitioner) and one of the
following 1. 3-5 Years of clinical experience or 2. 3-5 Years of
pharmaceutical experience (2 of which is in clinical development)
Or • Have a BS Or Masters Degree In Health/Medical/Scientific or
related field and 7-10 years of pharmaceutical experience that is
directly related to at least one of the following 1. Clinical trial
experience 2. Experience in areas relevant to drug discovery 3.
Drug/Clinical Development experience (for example, epidemiology,
toxicology, pharmacology, regulatory affairs, medical affairs)
Additional Skills/Preferences 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. • 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 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 $168,000 -
$294,800 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
Keywords: Eli Lilly and Company, Indianapolis , Clinical Research Scientist, Science, Research & Development , Indianapolis, Indiana
