Clinical Research Scientist - Breast Cancer Franchise

Position Overview

Employment Type: Full time

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.

The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.

This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.

This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills—particularly for external data disclosures and regulatory documentation.

Primary Responsibilities

• Contribute to the development and execution of clinical strategies for breast cancer programs.
• Maintain a focus on accelerating timelines while ensuring quality.
• Demonstrate compliance with procedures and be accountable for compliance of team members.
• Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
• Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
• Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
• Collaborate with Global Patient Safety on risk management planning.
• Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
• Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
• Participate in data analysis, scientific dissemination, and preparation of final study reports.
• Analyze and contextualize clinical data to support decision-making and portfolio strategy.
• Contribute to strategic planning and innovation through cross-functional working groups.
• Support planning and execution of symposia, advisory boards, and other external engagements.
• Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
• Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.

Scientific & Technical Expertise and Development

• Stay current with medical literature and scientific developments in breast oncology.
• Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
• Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
• Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.

Leadership & Professional Development

• Model leadership behaviors and lead matrixed, cross-functional teams.
• Direct supervision of