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Clinical Research Scientist – Medical Affairs (Rheumatology, United States)

Purpose

Through the application of scientific and clinical training and expertise in rheumatology, the Clinical Research Scientist (CRS) is an integral member of the U.S. Medical Affairs organization, supporting strategic planning and execution of medical activities across the product lifecycle to meet patients’ needs and enhance the experience of customers—patients, providers, and payers—in the United States.

The CRS contributes to the development and execution of U.S. and global clinical and medical plans in rheumatologic diseases, including autoimmune and inflammatory conditions, and supports launch and commercialization activities. The CRS works closely with global Development teams, Therapeutic Area Program Phase, Early Phase Clinical Pharmacology, Translational Medicine, and other cross-functional partners across the full spectrum of drug development and clinical trial phases.

The CRS ensures that activities are aligned with U.S. Medical Affairs strategic priorities and are conducted in compliance with applicable regulations, laws, guidance (e.g., FDA, ICH), Good Clinical Practices (GCPs), and company policies and procedures, while serving as a scientific resource for study teams and internal stakeholders.

Primary Responsibilities

Business / Customer Support (Pre- and Post-Launch)

• Provide expert scientific and clinical support to U.S. business activities across rheumatology.
• Understand and anticipate the scientific information needs of U.S. customers (patients, providers, and payers). 
• Contribute to development of medical strategies supporting commercialization activities in collaboration with global Medical Affairs, Global Patient Outcomes/Real World Evidence, PRA, and cross-functional teams.
• Contribute to pricing, reimbursement, and access activities by providing clinical input and supporting interactions with government and payer stakeholders.
• Participate in defining the patient journey and acting as a patient advocate within the rheumatology therapeutic area. 
• Support training of sales representatives and other medical personnel. 

Scientific Data Dissemination / Exchange

• Ensure knowledge of and compliance with U.S. regulations, global policies, and procedures governing scientific exchange and data dissemination. 
• Support development, review, and dissemination of scientific materials, including abstracts, posters, manuscripts, and educational content. 
• Establish and maintain collaborations and relationships with external scientific experts, thought leaders, and the medical community in rheumatology. 
• Support planning and execution of symposia, advisory boards, and other scientific interactions with health care professionals.
• Provide congress support, including presentations, medical booth staffing, and engagement with external stakeholders. 

Clinical Planning

• Collaborate with Medical Affairs leadership and global teams to ensure clinical and medical plans address U.S. rheumatology customer needs. 
• Communicate U.S. research needs and insights to global Medical Affairs, Development, and Patient Outcomes teams. 
• Represent U.S. clinical needs in the development of clinical strategies, development plans, and study protocols.
• Maintain up-to-date knowledge of pre-clinical and clinical data relevant to rheumatology assets. 

Clinical Research / Trial Execution and Support

• Collaborate in the design, conduct, and reporting of clinical trials, including Phase I–IV and non-interventional studies conducted in the U.S. 
• Participate in investigator identification and selection and serve as a scientific resource to investigators and study teams. 
• Ensure compliance with Good Clinical Practices, regulatory requirements, and ethical standards.
• Monitor patient safety and ensure appropriate tracking and follow-up of adverse events in alignment with corporate patient safety policies. 

Regulatory Support Activities

• Provide clinical expertise for U.S. regulatory activities, including labeling, submissions, and interactions with regulatory agencies. 
• Support preparation of regulatory documents and participation in advisory committees as appropriate. 
• Participate in risk management planning in collaboration with global Development and Global Patient Safety teams. 

Scientific / Technical Expertise

• Maintain awareness of current trends and projections in rheumatology clinical practice and access. 
• Critically evaluate scientific literature and remain informed on competitive landscape and emerging therapies. 
• Serve as a scientific consultant and protocol expert within Medical Affairs and cross-functional teams. 

General Responsibilities

• Align activities with Medical Affairs priorities and organizational objectives.
• Collaborate proactively with internal teams and external partners. 
• Contribute to coaching, development, and team effectiveness. 
• Model leadership behaviors and act as an ambassador of patients and the organization.   

Minimum Qualifications:

• Advanced health/medical/scientific degree (PharmD, PhD, MSN with clinical specialty)
• Minimum 3 years’ experience in any of the following: clinical, pharmaceutical, clinical development, research.

Preferred Qualifications:

• 5 years’ experience within rheumatology, immunology, or closely related therapeutic areas, with exposure to clinical research or Medical Affairs activities.
• Demonstrated understanding of the drug development lifecycle
• Proven experience and strong working knowledge of U.S.-based clinical and/or Medical Affairs activities, including familiarity with applicable regulatory and compliance frameworks.
• Demonstrated scientific expertise, communication skills, and ability to collaborate and influence cross-functional teams. 
• Ability to travel as required to support business needs 

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

$151,500 - $244,200

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.

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