Sr. Director - Clinical Affairs

Company: Eli Lilly and Company
Location: Redwood City
Posted on: February 13, 2026

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 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. Position Summary The Sr Director, Clinical Affairs plays a critical role in supporting the Clinical Development (CD) team by providing scientific and technical expertise and will bring experience in designing and conducting clinical trials. This position serves as a liaison between CD and other cross-functional groups and is responsible for setting and implementing strategies across the CD program, providing oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies. What you’ll do: Collaborate with CD to review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses to support interactions with US and Global Health Authorities Serves as CD/medical monitor (MM) liaison/point-of-contact for inquiries from both internal and external stakeholders, clinical sites, vendors, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation, supports the Clinical Trial Liaison Team (CTL) by providing timely clinical/medical responses to sites Identifies and mitigates protocol risks, performs ongoing review and monitoring of protocol deviations (PDs), drives PD review meetings, and develops strategies for protocol retraining and improving site compliance Writes and/or reviews content for protocol training, site initiation visits, and investigator/study coordinator meetings, clinical presentation slides, scientific meetings, conferences, other events and presentations, and contributes to scientific publication of study results as needed Contributes as CD/MM representative during clinical system updates (EDC/IRT) Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, study coordinators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory, clinical operations, data management, data analytics/visualization, biostatistics, clinical supply, and quality Uses CD/MM expertise to perform ongoing clinical data review Participates in ongoing enhancements and development of team processes, structures, and tools, while supporting the development and training study team members Minimum Requirements: PhD preferred, PharmD with relevant experience may be considered 10 years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) Additional Preferences: Gene therapy and/or ophthalmology (retina) experience preferred. Ability to proactively predict issues and solve problems Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team Diplomacy and positive influencing abilities Committed to developing and mentoring team Therapeutic area knowledge relevant to mechanism of action and retinal drug development Understanding of US and Global Regulatory requirements 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 $163,500 - $281,600 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. WeAreLilly

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