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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:

Lilly has innovated in diabetes care since 1923, when we introduced the world's first commercial insulin. We are currently building upon this heritage by working to meet the diverse needs of people with diabetes, obesity, and complications. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by these diseases and those who care for them. Today, Lilly strives to become the next leader in cardiovascular and renal diseases. We are looking for a clinical research scientist (CRS) to provide clinical development support to a rapidly growing cardio-renal portfolio.

The cardio-renal CRS is a critical member of the clinical development team who engage in clinical trial planning, trial conduct, and trial closure for molecules in development for heart failure, atherosclerosis and lipid management, renal diseases, pulmonary hypertension, atrial fibrillation, and related diseases; as well as provide CRS support for our diabetes and obesity portfolio as needed. The CRS responsibilities include contribution in the development, conduct, and reporting of global clinical trials for new molecules; 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 CRS 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 TA 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.

The TA program phase CRS actively participates in and supports Lilly's Vision and strategies including, but not limited to, innovation (tailored therapies and solutions), collaboration, social responsibility, improving value, and execution.

**Primary Responsibilities** : This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with the hiring manager regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibilities of the Cardio-renal and Diabetes, Obesity & Complications program phase CRS are generally related to early-phase molecules.

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 early-phase clinical strategy and planning.

+ Collaborate with internal and external collaborators on global Phase Ib and IIa/IIb trials.

+ Integrate study development with disease progression and drug-response modeling.

+ Partner with discovery scientists on compound selection and pre-clinical development.

+ Translate non-clinical findings into human studies, including biomarker development.

+ Support pharmacokinetic and pharmacostatistical modeling.

Clinical Research Execution

+ Design and oversee Phase Ib and IIa/IIb studies and biomarker qualification methods.

+ Write protocols and collaborate on data collection requirements.

+ Participate in investigator selection and trial conduct.

+ Ensure ethical and regulatory compliance.

+ Provide training and support to site personnel.

+ Monitor patient safety and adverse event reporting.

Scientific Data Dissemination

+ Align with global policies on data sharing and professional interactions.

+ Address scientific inquiries from healthcare professionals.

+ Support clinical trial registry activities and health economic evaluations.

+ Contribute to symposia, advisory boards, and publication development.

+ Provide congress support and respond to media inquiries.

Regulatory Support

+ Assist with regulatory documentation and communications.

+ Collaborate on labeling and risk management planning.

+ Provide medical expertise to regulatory teams.

Business and Customer Engagement

+ Understand the needs of diverse stakeholders (patients, providers, payers).

+ Advise on market potential and support business development.

+ Build relationships with external experts and professional societies.

+ Advocate for patient-centered approaches and define key patient journey moments.

Scientific & Technical Development

+ Stay current with medical literature and scientific advancements.

+ Consult on health outcomes and market access strategies.

+ Pursue extramural scientific opportunities and attend symposia.

+ Maintain awareness of clinical practices and therapeutic trends.

General Responsibilities

+ Set and pursue professional development goals.

+ Support recruitment, diversity, and retention efforts.

+ Participate in committees and initiatives.

+ Lead cross-functional teams and model inclusive leadership.

+ Represent Lilly’s brand and values.

Internal Collaborations

+ Therapeutic area leadership

+ Scientific leaders and program directors

+ Global brand and product planning teams

+ Clinical development and research staff

+ Regulatory, legal, and safety teams

External Collaborations

+ Scientific and clinical experts

+ Investigators and practicing clinicians

+ Regulatory agencies

+ Professional associations

+ Advocacy and community organizations

Job Requirements

+ PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years’ industry experience

+ Ability to **travel domestically and internationally** up to 15% as needed

Additional Skills/Preferences

An Advanced Health/Medical/Scientific degree in the life sciences (for example - pharmacology, physiology, microbiology, genetics) 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)

+ Ability to balance scientific priorities with business priorities with examples of successful leadership skills

+ Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills

+ Capacity to influence others (both cross-functionally and within the function) 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

$156,000 - $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.

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