Clinical Research Scientist - Breast Cancer Franchise

Role Summary

The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise focuses on late‑phase assets within an evolving portfolio. The role designs, executes, and analyzes clinical trials for innovative breast cancer therapies, ensuring medical activities align with the medical vision and comply with applicable regulations, GCPs, and Lilly policies. The CRS collaborates with cross‑functional partners to advance the oncology pipeline, identify and mitigate risks, and contribute to regulatory submissions and external data disclosures. Leadership and mentoring of junior scientists are required, along with strong written communication for regulatory documentation and external data disclosures.

Responsibilities

• Contribute to the development and execution of clinical strategies for breast cancer programs, balancing accelerated timelines with quality.
• Ensure procedural compliance and accountability for the team’s compliance.
• Lead the 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.
• Partake 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.

Qualifications

• Required: PhD with 3+ years of industry experience, or BS degree with 10+ years’ industry experience in a health‑related field, plus 3+ years of clinical research/scientific trial experience; demonstrated leadership experience.
• Preferred: Direct line leadership experience; breast cancer disease state knowledge/experience; advanced health/medical/scientific graduate degree (PharmD, PhD, MSN with advanced clinical specialty).
• Required: Experience across all phases of a trial lifecycle (design, start‑up, implementation, regulatory submission).
• Required: Strong communication, interpersonal, teamwork, organizational, and negotiation skills; ability to influence cross‑functional teams.
• Preferred: Travel flexibility (domestic and international) to support business needs; fluent in English (verbal and written).

Skills

• Scientific consultation to medical affairs, health outcomes, and commercial teams.
• External scientific engagement planning and execution; attendance at relevant symposia.
• Ability to develop and review scientific materials (slides, abstracts, posters, manuscripts).
• Strategic thinking to contextualize clinical data for decision‑making and portfolio strategy.

Education

• PhD or higher, or BS with extensive industry experience in health-related fields as specified in qualifications.

Additional Requirements

• Direct line leadership experience; breast cancer disease state knowledge/experience.
• Ability to engage in domestic and international travel as needed to support the team’s goals.
• Fluent in English, both verbal and written.