Eli Lilly

Sr Clinical Outcomes Assessment Scientist

Posted on: 15 Mar 2022

Indianapolis, IN

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.

Responsibilities:

The demand for high quality health economic and outcomes research (HEOR) and real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision making continues to increase.  The purpose of the Lilly Value, Evidence, and Outcomes (VEO) team is to accelerate equitable patient access and transform healthcare delivery through the execution and communication of bold, high impact science.  We are looking for talented, energetic, creative, diverse, influential, and collaborative team members to join the VEO function and Team Lilly.

The ­­­VEO research scientist will provide scientific expertise and effective project oversight to ensure that patients’ perspectives are incorporated into drug development, including in evaluation of treatment benefit and when assessing benefits and risks of treatments in Lilly’s diabetes/cardiovascular portfolio.

The VEO Scientist collaborates cross-functionally as an expert in Clinical Outcome Assessments (COAs), including Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), Observer Reported Outcomes (ObsROs) and Performance Outcome Assessments (PerfOs). The scientist will use their expertise in Clinical Outcome Assessments (COAs), therapeutic area knowledge of diabetes and cardiovascular disease states, understanding of drug development and commercialization, and geographic market knowledge in the role. The scientist will collaborate cross-functionally to develop effective COA strategies across the disease states as well as design and execute measurement-related (including instrument development/adaptation/validation) studies as needed to support research across the portfolio and spanning the lifecycle of development.

Primary Responsibilities:

Strategy

Drives sustained integration of HEOR and patient measurement/COA strategies from early clinical development through commercialization of diabetes/cardiovascular assets.
Develops and oversees COA research strategy for compounds in the Lilly diabetes/cardiovascular portfolio.
Serves as a strategic partner on asset and study teams throughout development, registration, and commercialization
Formulates and drives patient measurement/COA strategies for priority products and geographies.

Study Development and Execution

Develops bold high impact science for products across the lifecycle, to influence and support evidence needs for Lilly products in support of improving patient outcomes.
Applies deep patient measurement/COA technical expertise.
Applies disease state knowledge and research methods to solve patient measurement/COA needs associated with registration, access, and communication initiatives.

Organizational Leadership and Influence

Links technical expertise with business acumen and establishes and maintains strategic relationships with key internal and external decision makers.
Effectively leads patient measurement/COA evidence planning and implementation in collaboration with cross-functional teams across the development and commercialization lifecycle teams.
Effectively integrates with and influences key business partners and external stakeholders to achieve goals and outcomes related to COA strategies and advancing the application of patient measurement to drug development and commercialization

Information Dissemination

Effectively communicates patient measurement/COA information to internal business partners, the scientific community, and customers.
Drives research dissemination strategies and leads research communication efforts including abstracts, posters, podium presentations, promotional materials and manuscripts.
Plan for, align, and drive application of results/ deliverables to increase the impact of patient measurement/COA research.

Environmental Awareness

Maintains awareness of significant developments in disease states in the Lilly portfolio and patient measurement/COA field including current methodologies and applications and other issues.
Anticipates and evaluates future market needs and trends for patient measurement/COA information within diabetes/cardiovascular globally.
Monitors and influences internal and external environmental factors that shape and impact generation and use of patient measurement/COA research.

Project Management

Ensures patient measurement/COA projects meet timelines, budget, and scope by coordinating research efforts with cross-functional Lilly business partners and external collaborators as appropriate.

Basic Qualifications/Requirements:

Doctorate (PhD, MD) with 5-11 years OR PharmD/MS degree with 5-11 years of experience in creating, executing, and delivering patient measurement/ clinical outcomes assessment (COA) strategies and projects.

Additional Preferences/Information:

Understanding of regulatory processes and expectations for COA acceptance and patient measurement promotional claims in the US and EU
Understanding of and experience with clinical research and product registration
Technical and analytic capabilities in clinical outcomes assessments and drug development regulatory policy
Demonstrated ability to drive research agendas to completion and dissemination
Ability to think and act globally with a customer focus and a solution orientation
Strong comprehension and communication skills including the ability to translate and disseminate complex scientific information in a clear and concise manner
Excellent written and verbal communication skills
Demonstrated ability to influence and collaborate within and across teams

Additional Information:

Location is flexible.
Domestic and international travel may be necessary.

Eli Lilly

Indianapolis, IN

Eli Lilly and Company discovers, develops, manufactures, and markets pharmaceutical products worldwide. The company operates in two segments, Human Pharmaceutical Products and Animal Health Products. It offers endocrinology products for the treatment of diabetes; osteoporosis in postmenopausal women and men; and human growth hormone deficiency and pediatric growth conditions.

The company also provides neuroscience products for the treatment of depressive disorder, diabetic peripheral neuropathic pain, anxiety disorder, fibromyalgia, and chronic musculoskeletal pain; schizophrenia; attention-deficit hyperactivity disorder; obsessive-compulsive disorder, bulimia nervosa, and panic disorder; and positron emission tomography imaging of beta-amyloid neurotic plaques in adult brains, as well as migraine prevention. In addition, it offers immunology products for the treatment of rheumatoid arthritis and plaque psoriasis; oncology products to treat non-small cell lung, colorectal, head and neck, pancreatic, metastatic breast, ovarian, bladder, and metastatic gastric cancers, as well as malignant pleural mesothelioma; and cardiovascular products to treat erectile dysfunction and benign prostatic hyperplasia, and acute coronary syndrome.

Further, the company provides animal health products, such as cattle feed additives; leanness and performance enhancers for swine and cattle; antibiotics to treat respiratory and enteric diseases in swine and poultry; anticoccidial agents for poultry use; and chewable tablets that kill fleas and prevent heartworm diseases. Additionally, it offers vaccines to prevent bordetella, Lyme disease, rabies, and parvovirus.

The company has collaboration agreements with Daiichi Sankyo Co., Ltd.; Incyte Corporation; Pfizer Inc.; AstraZeneca; Nektar Therapeutics; NextCure, Inc.; Dicerna Pharmaceuticals; AC Immune SA; and Avidity Biosciences, Inc. Eli Lilly and Company was founded in 1876 and is headquartered in Indianapolis, Indiana.

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