Clinical Research Physician – Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Scientific and medical training, clinical expertise, and relevant clinical experience
Awareness of and compliance with current local and international regulations, laws, guidances (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements, and Principles of Medical Research
Alignment of medical team activities with the medical vision

Responsibilities

Participate in the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of the product
Implement global clinical trials
Report adverse events as mandated by corporate patient safety
Review protocols, study reports, publications, and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions, and contracts
Engage in contacts with regulatory and other governmental agencies
Conduct outreach medical activities aimed at the external clinical customer community, including thought leaders
Develop and implement the business unit and global strategy for the product
Support various medical activities in demand realization
Serve as a scientific resource for study teams, departments, and others as needed
Collaborate with business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition addressing key customer needs (patient, provider, payer); product lifecycle plan, clinical strategies, development plans, and study protocol design
Contribute to business unit and global alignment of clinical strategy and clinical plans
Understand and stay updated with pre-clinical and clinical data relevant to the molecule
Plan, collaborate on, and review scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to agreed project timelines
Provide oversight and input into ICDs
Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions)
Review and approve risk profiles to ensure appropriate communication of risk to study subjects
All other duties as assigned by line management

Skills

Clinical Trials

GCP

FDA

ICH

Protocol Development

Adverse Event Reporting

Regulatory Compliance

Study Reports

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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