Clinical Research Scientist - Breast Cancer Franchise at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Demonstrated leadership in clinical development
Strong mentoring capabilities
Exceptional written communication skills, particularly for external data disclosures and regulatory documentation
Deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data in breast oncology
Stay current with medical literature and scientific developments in breast oncology

Responsibilities

Contribute to the development and execution of clinical strategies for breast cancer programs, maintaining 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
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
Model leadership behaviors and lead matrixed, cross-functional teams
Direct supervision of team members

Skills

Clinical Research

Clinical Trials

Oncology

Breast Cancer

GCP

FDA Regulations

ICH Guidelines

Regulatory Submissions

Clinical Strategy

Risk Assessment

Data Analysis

Mentoring

Leadership

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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