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.

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

Summary 

We have an excellent opportunity for a skilled, talented, and highly motivated individual to join the phase 3 Cardiovascular development team. The role of Clinical Research Scientist (CRS) will be a key member of the Lilly Cardiovascular (Cardio Metabolic Health) Medical team, which will be involved in all aspects of large, multicenter, pivotal, phase 3 Cardiovascular clinical trials within the Lp(a) lowering portfolio. These studies are complex and conducted globally. The CRS will work directly or in collaboration with other members of the medical team and other functional areas in the following key activities: develop clinical development plans, develop protocol synopsis, prepare clinical sections of regulatory documents, work in close collaboration with the Clinical Operation and Data Management teams, collaborate with external partners such as AROs and CROs, oversee the conduct of clinical trials, conduct investigator training, participate in data and safety review activities, provide medical direction to Clinical Operations, represent the Medical function in cross-functional teams and discussions. The CRS will work in close collaboration with the Clinical Research Physician. 

An ideal candidate is a person who is motivated, has an agile mind-set, is willing to learn and adapt, shows a positive and proactive attitude, is a great team player, and wants to make a difference in the lives of patients. The person should use a strong foundation of technical experience to enrich decision-making, identify efficiencies, and increase the probability of technical success of projects. 

Capabilities 

Challenges the status quo and champions breakthrough approaches to implement novel solutions to scientific issues and/or processes. Acts with speed, agility, and decisiveness to identify the critical issues to resolve; influences team and/or key stakeholders on the critical risks and plan for resolution. Creates an environment for open scientific debate, integrates information, and boldly drives to decisions or actions where no process/precedent exists. Champions changes that increase the effectiveness of the overall drug research, development, and commercialization. 

  

  

Responsibilities 

Study Design and Planning 

Provides clinical and scientific contributions to clinical development plans, preparation of regulatory documents, protocol development and writing, development of eCRF/EDC, setting up clinical event committees and other key committees (IDMC, Executive Committee, etc.), including development of charters. 

Study Start-up 

Supports Clinical Operation in developing planning documents, works with regulatory and ethics committees (e.g., RFIs response), prepares and keeps up to date FAQs, contributes to site and patient-facing materials, planning documents, regulatory/ethics, FAQs, site and patient-facing materials, collaborates with AROs/CROs. 

Study Team and Investigator Training 

Contributes to the development of training modules, Investigator webinars, Investigator meetings, and CRA/staff training. 

Medical Oversight of Clinical Trials 

Uses available tools to monitor study conduct (screening, randomization, adjudication, retention). Participates in and leads safety and data cleaning activities (medical listing review, periodic safety review, preparation for IDMC review). Quality control of tables, listings, and graphs before database lock. 

Communication with Sites 

Supports site/CRA communication: protocol/medical questions, lab alerts and follow-up, Q&A documents, issues management, lab alerts. 

Internal and External Collaboration 

Engages with internal and external experts. Contributes to Ad Boards as needed. Interacts with KOLs, prepares material for KOL interaction as needed. Participates in cross-functional and company-wide initiatives as required. Participation in the development of publication plans, including contribution as an author in abstracts/manuscripts. 

Impact on Lilly 

Actively mentors and coaches diverse talents, including giving constructive feedback.  Develops, motivates, and creates opportunities for others to be highly productive and contribute to the success of the Cardiovascular area. 

  

  

Minimum Qualifications 

Master's, PharmD, or PhD in a scientific field5 years of work in clinical development in Pharma or equivalent experience, which must include direct participation in the conduct of randomized clinical trials 

Additional Skills and Preferences

Prior experience in large cardiovascular outcome trials is strongly preferred Prior work in complex matrix, cross-functional teams with multiple geographical locations 

Location/Travel 

Primary Location: Indianapolis, US. A remote/hybrid position can be considered for the right candidate, with travel to Lilly Headquarters at regular intervals and as needed Business travel as needed (may vary with time but is not expected to exceed 10%). 

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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