Clinical Research Scientist - Breast Cancer Franchise

Role Summary

The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise focuses on late‑phase assets, driving the design, execution, and analysis of clinical trials for innovative breast cancer therapies. The CRS ensures medical activities align with the medical vision, regulations, GCPs, and Lilly policies, and collaborates across medical affairs, clinical operations, regulatory, statistics, and data science to advance the oncology pipeline and improve patient outcomes. The role includes supervisory responsibilities and requires leadership in clinical development, mentoring capabilities, and strong written communication for external data disclosures and regulatory documentation.

Responsibilities

• Contribute to the development and execution of clinical strategies for breast cancer programs, balancing accelerated timelines with quality.
• Ensure procedure compliance and accountability for team members.
• Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
• Lead and contribute to 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 strategy 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.

Skills

• Stays current with medical literature and scientific developments in breast oncology.
• Maintains deep knowledge of clinical practice trends, access considerations, and relevant preclinical/clinical data.
• Provides scientific consultation to medical affairs, health outcomes, and commercial teams.
• Assists in planning and execution of external scientific engagement opportunities and attendance at relevant symposia.
• Demonstrates leadership in matrixed, cross-functional teams and mentors junior scientists.

Education

• PhD with 3+ years of industry experience OR BS Degree with 10+ years’ industry experience in a health-related field.

Qualifications

• 3+ years of clinical research scientist experience/clinical trial experience.
• Leadership experience.

Additional Requirements

• Direct line leadership experience; breast cancer disease state knowledge/experience.
• Advanced health/medical/scientific graduate degree (e.g., PharmD, PhD, MSN with advanced clinical specialty).
• Experience with all phases of a trial lifecycle: design, study start up, implementation, regulatory submission.
• Strong communication, interpersonal, teamwork, organizational, and negotiation skills.
• Demonstrated ability to influence cross-functional teams and foster a positive working environment.
• Ability to travel domestically and internationally as needed to support the business.
• Fluent in English, both verbal and written.