Medical Affairs Immunology - Clinical Research Scientist
Location: Indianapolis
Posted on: June 23, 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. Through the application of
scientific and clinical training and expertise, the Clinical
Research Scientist (CRS) is an integral member of the medical
affairs, development or a business unit brand team for strategic
planning in the support of launch and commercialization activities
to meet patients' needs and ultimately enhance the customers'
experience in interacting with the company. The definition of
"customer'' here includes patients, providers (HCPs) and payers.
The CRS may also work closely with global Development teams,
Therapeutic Area Program Phase, Early Phase / Clinical
Pharmacology, and Translational Medicine teams in new product
development activities over the entire spectrum of drug development
and clinical trial phases. Specific activities include developing
or contributing to the global and/or regional clinical/medical plan
in his/her therapeutic area of responsibility, the development,
conduct and reporting of local clinical trials; the implementation
of global clinical trials conducted in local affiliates/countries;
the reporting of adverse events as mandated by corporate patient
safety; 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; the outreach medical
activities aimed at the external clinical customer community,
including thought leaders; and various medical activities in
support of demand realization. In addition, with input from the
Director-Medical and Business Unit Team Physician/Regional Medical
Leader, the CRS is responsible for assuring that his/her activities
are clearly aligned with the strategic priorities of the respective
Medical Affairs business unit brand team(s), global Development
team, Therapeutic Area Program Phase, Early Phase/ Clinical
Pharmacology, and Translational Medicine team(s). The Clinical
Research Scientist serves as a scientific resource for study teams,
departments, and others as needed. The CRS is aware of and ensures
that all activities of the medical team (and direct reports, if
applicable) are in compliance with current local and international
regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.),
Good Clinical Practices (GCPs), company standards, Lilly policies
and procedures, global quality standards, the Principles of Medical
Research and activities are aligned with the medical vision. The
primary responsibility of the Business Unit- Medical Affairs CRS is
to provide expert scientific and clinical support to all aspects of
the local business, to ultimately enhance the customers' experience
in interacting with the company. In an effort to fully understand
external opinions, issues, and new science in the areas in which
Lilly operates, CRS gather and communicate scientific intelligence
and clinical insights identified through their interactions with
Scientific Experts and other Health Care Providers, Scientific
Exchange Meetings, their attendance at medical conferences, and
through other appropriate means to better inform Lilly's strategic
direction for research and commercialization. This includes local
marketed product support (participate in the development of the
"patient journey'' and the strategic plan for the compound), and
leading in local scientific data dissemination (leading and
presenting at conferences, advisory boards, scientific exchange
meetings, etc., and overseeing the development of the scientific
content of educational programs). These responsibilities are
generally related to late-phase and marketed compounds, but can
also include early phase trials (for example, phase I and II
trials). The CRS is responsible for collaborating with the global
teams in the planning, startup and conduct of phase 3b/4 studies
(and phase I and II studies where applicable), as well as
non-clinical trial solutions/activities that are conducted in
affiliates/countries as described in the clinical plan. In
addition, the CRS, if assigned by the Director-Medical and/or
Business Unit Team Physician/Regional Medical Leader, is
responsible for support of global Development studies conducted in
affiliates/countries. The core job responsibilities may include
those listed below as deemed appropriate by line management, as
well as all other duties as assigned. Business/ customer support
(pre and post launch support) Understand and anticipate the
scientific information needs of all local/regional customers
(payers, patients, health care providers) Actively address customer
(payer, patient and health care providers) questions in a timely
fashion by leading data analyses and new clinical or health
outcomes research efforts. Contribute to the development of medical
strategies to support brand commercialization activities by working
closely with the global Medical Affairs and brand teams, Global
Patient Outcomes/Real World Evidence and global PRA, clinical
management or personnel and other cross-functional management
during the development of the local business plan. Contribute as a
scientific and clinical expert to activities and deliverables of
the PRA organization, in particular giving clinical input and
insight to develop payer partnership programs and defend the
product value. Support business-to-business and
business-to-government activities as medical expert. Contribute
actively on an ongoing basis to the strategic planning for
currently marketed brands. By offering scientific and creative
input, contribute to the development, review, and approval of
promotional materials for the brand team. Support training of sales
representatives, and other medical representatives. 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 patient advocate, as well as a
medical expert. Provide medical insight and training to patient
support programs (for example, Diabetes Nurse Educators Service).
Understand and apply knowledge of customer insights to all
customer-related activities. Participate in local or national trade
associations as appropriate. 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. Support the planning of symposia,
and actively participate in advisory board meetings, scientific
exchange meetings, and the facilitation of other meetings with
health care professionals. Support medical information associates
in preparation and review of medical letters and other medical
information materials. Support training of local medical personnel,
including medical and/or outcome liaisons and health outcomes
staff. Prepare or review scientific information in response to
customer questions or media requests. Provide follow-up to
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 scientific 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. 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 analyses,
development of scientific data dissemination, and preparation of
final reports and publications. Participate in reporting of
clinical trial data in Clinical Trial Registry activities. Clinical
Planning Communicate and collaborate with Director-Medical and
Business Unit Team Physician/Regional Medical Leader as needed to
ensure life cycle plans for drugs in development address customer
needs or communicate and collaborate such needs as delegated by
Director-Medical and Business Unit Team Physician/Regional Medical
Leader, as needed, to global Medical Affairs and Development teams,
Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area
Program Phase, and Early Phase /EPM/Translational Medicine teams.
Communicate local/regional research needs and collaborate with
other regions and the global Development and Medical Affairs teams,
Global Patient Outcomes/Real World Evidence, and PRA teams to
ensure Phase 3, 3b, and 4 (and Phase I and II where applicable)
clinical programs meet the needs of local/regional customers (for
example, through global medical planning processes). Understand and
keep updated with the pre-clinical and clinical data relevant to
the molecule. Represent the clinical needs of the country/region to
the business unit medical leadership in the development of clinical
strategies, development plans and study protocol design. Clinical
Research trial /Execution and Support Review and approve local
informed consent documents and risk profiles to ensure appropriate
communication of risk to study subjects. 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). Collaborate
with clinical research staff, regional clinical operations staff,
statisticians, global patient outcomes, research scientists and
selected investigators in the development of protocols and data
collection requirements. Participate in investigator identification
and selection, in conjunction with clinical teams. Ensure that the
clinical operations 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 the planning
process and participate in study start-up meetings and other
activities to provide the appropriate scientific training and
information to investigators and site personnel. Serve as resource
to clinical research site monitors, investigators and ethical
review boards to address any questions or clarify issues arising
during the conduct of study. Review IIT proposals and publications,
as requested Contribute to global alignment of Phase 3b/4 clinical
studies (and Phase land II studies where applicable) planned by
country (ies) or global Development and Medical Affairs teams.
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. Regulatory Support Activities
Participate in development and review of local labeling and
labeling modifications in collaboration with global Development,
brand teams, regulatory, and legal. Demonstrate deep knowledge of
local label. Provide medical expertise to regulatory scientists.
Support/ assist in the preparation of regulatory reports,
preparation for regulatory agency advisory committee hearings and
label discussions, local registration efforts, and communication
and resolution of regulatory issues, including regulatory response,
from an affiliate/country perspective. Participate in advisory
committees. Participate in risk management planning along with
global Development team(s), business unit, local area, and Global
Patient Safety (GPS). Scientific I Technical Expertise and
continued development Be aware of current trends and projections
for clinical practice and access in the therapeutic area(s)
relevant to the product, both near term (1-2 years) and longer-term
(3-5 years). 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. 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, contribute and participate in
medical congresses/scientific symposia. General Responsibilities
Support the business unit management team, including medical
leadership in preparation and administration of the local or
business unit medical budget. 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, and direct reports as applicable. Collaborate
proactively and productively with all alliance, business, and
vendor partners. Participates in active coaching by providing
timely and constructive feedback to co-workers, others on the
clinical medical team, in the spirit of development, increased team
effectiveness and cohesiveness. As applicable, works closely with
direct reports on performance management plans (objectives),
development plans, and documentation of their expertise. Keeps
these documents and plans up to date. Meets regularly with each
direct report to coach, mentor, evaluate performance, evaluate
training and development needs, and monitor career development
goals. Maximizes each individual direct report's career potential,
maximizing the value to the organization. Actively participate in
recruitment, diversity, and retention and hiring efforts as
applicable. Participate in committees, Six Sigma initiatives and
task forces as requested by business unit/corporate management.
Model the leadership behaviors. Be an ambassador of both patients
and the Lilly Brand. MINIMUM R E QUIREMENTS An advanced
health/medical/scientific (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 at least one year of Pharma
Experience in Gastroenterology Therapeutic Area OTHER INFORMATION
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers Product
directors, managers, and associates of the brand Clinical research
staff Statisticians Scientific communication associates Medical
information associates Medical liaisons Global patient outcomes
research consultants/research scientists and health outcomes
liaisons Regulatory directors, scientists, and associates Sales
representatives Legal counsel Therapeutic area physicians, global
brand physicians, early phase physicians, clinical research
scientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s) Location:
Indianapolis, IN. or Remote option may be available. 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 $142,500 -
$228,800 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: , Terre Haute , Medical Affairs Immunology - Clinical Research Scientist, Science, Research & Development , Indianapolis, Indiana
