Clinical Research Scientist - Breast Cancer Franchise

Chester, Maryland, United States

Apply with AI Apply

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates should possess a strong understanding of breast cancer and clinical development, with a focus on late-phase assets. Demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills are required. The role necessitates a thorough knowledge of regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), and company standards. Experience in collaborating with cross-functional partners such as medical affairs, clinical operations, regulatory, statistics, and data science is essential. The ability to proactively identify, assess, and mitigate risks related to medical oversight of clinical trials is also a key requirement.

Responsibilities

The Clinical Research Scientist will be responsible for the design, execution, and analysis of clinical trials for breast cancer therapies, ensuring compliance with all relevant regulations and standards. Key duties include leading the completion of clinical trial documents, supervising medical monitoring activities, and collaborating with internal teams and external partners on scientific integrity and operational excellence. The role also involves serving as a scientific resource for study sites and ethics committees, providing scientific input for various meetings and training, and participating in data analysis and scientific dissemination. Additionally, the scientist will contribute to strategic planning, external engagements, the development of scientific materials, and support regulatory submissions and health authority interactions.

Skills

Clinical Trial Design

Clinical Trial Execution

Clinical Trial Analysis

Breast Cancer Therapies

Regulatory Submissions

Data Disclosure

Medical Affairs

Clinical Operations

Regulatory Affairs

Statistics

Data Science

Oncology Pipeline

Patient Outcomes

Risk Mitigation

Leadership

Mentoring

Written Communication

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.

Land your dream remote job 3x faster with AI

Try Jobo Free