Clinical Research Scientist - Breast Cancer Franchise

Role Summary

The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise focuses on late phase assets, guiding the design, execution, and analysis of clinical trials for innovative breast cancer therapies. The role ensures medical activities align with the medical vision, regulatory requirements, GCPs, and Lilly policies, while collaborating across functions to advance the oncology pipeline and improve patient outcomes. Leadership, mentoring, and clear scientific communication are essential for external data disclosures and regulatory documentation.

Responsibilities

• Contribute to the development and execution of clinical strategies for breast cancer programs, emphasizing accelerated timelines and quality.
• Ensure procedural compliance and accountability for team members.
• Lead the preparation 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 maintain 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.

Qualifications

• PhD with 3+ years of industry experience OR BS degree or equivalent in a health-related field with 10+ years of industry experience
• 3+ years of clinical research scientist experience / clinical trial experience
• Direct line leadership experience
• Breast cancer disease state knowledge/experience (preferred)

Skills

• Strong scientific and technical expertise in breast oncology
• Excellent written and verbal communication for external data disclosures and regulatory documentation
• Ability to mentor and lead cross-functional teams
• Proven ability to influence across functions and build a positive working environment
• Strategic planning, data analysis, and ability to contextualize clinical data for decision making
• Effective collaboration with medical affairs, regulatory, statistics, and clinical operations
• Travel willingness domestically and internationally as needed

Education

• PhD with 3+ years of industry experience, or BS degree with 10+ years of industry experience (as applicable per qualifications)
• Advanced health/medical/scientific graduate degree (e.g., PharmD, PhD, MSN with clinical specialty) (preferred)

Additional Requirements

• Ability to engage in domestic and international travel as needed
• Fluent in English, both verbal and written