The posting
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
About the Role
You will help make sure our clinical studies are safe, well documented, and ready for inspection. You will also act as a scientific resource for internal teams, customers, and business partners, supporting everything from protocol questions to regulatory submissions.
Key Responsibilities
Trial Project Management
- Lead the planning and delivery of Phase 1 studies, including first-in-human, single and multiple ascending dose, and food effect or drug interaction studies, from startup through database lock and study closeout.
- Oversee Phase 1 clinical units, CROs, and vendors such as bioanalytical labs, central labs, and pharmacokinetic (PK) service providers.
- Manage the study budget, forecast spend, and review vendor invoices and change orders.
- Partner with Clinical Pharmacology, Regulatory, Safety, Biostatistics, Data Management, and Supply Chain to keep study activities aligned.
- Make sure clinical supplies, including investigational product and comparators, are available at the unit when each cohort is ready to dose.
- Run regular status meetings with study teams and vendors, and give leadership clear updates on progress, issues, and decisions needed.
Study Quality and Compliance
- Plan and carry out study-level safety reviews.
- Keep the Trial Master File (TMF) maintained and archived so it is always inspection-ready.
- Confirm that data in Vault Clinical is accurate and complete.
- Take part in responses to inspections, assessments, and audits.
Scientific and Therapeutic Area Expertise
- Answer protocol and technical questions from customers and business partners.
- Make sure user needs are met in device design, user instructions, and training materials, where relevant.
- Provide scientific input on clinical and regulatory documents, including:Study protocols and Investigator Brochures (IBs) Risk profiles and annual reports Briefing documents and New Drug Applications (NDAs) Safety updates and study reports Abstracts, publications, and manuscripts
- Advise on, or draft, responses to questions from regulatory agencies and affiliates.
Minimum Qualifications
- Bachelor’s degree with 3 years of clinical research experience, or relevant experience in a scientific or health-related field.
Additional Preferences
- Master’s degree
- Phase 1 experience preferred
- Proven ability to work well across cultures and in a virtual environment.
- Strong knowledge of the regulations and guidelines that apply to running clinical studies.
- Proficiency with Excel, Project, risk management tools, and budget monitoring and control tools. Strong leadership and networking skills.
- Clear, effective communication.
- Proven problem-solving ability.
- Strong self-management, organizational, and interpersonal skills.
- Solid verbal reasoning, attention to detail, critical thinking, and analytical skills.
- Experience working on cross-functional teams or projects.
- Willingness to travel, up to 10% (this varies with your responsibilities).
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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $154,000
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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