Clinical Research Physician - Incretin Clinical Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Scientific and medical training, clinical expertise, and relevant clinical experience
Awareness and compliance with 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
Adequately qualified and trained in required tasks, including maintaining a current curriculum training map
Ability to serve as a scientific resource and leader for study teams, departments, and others

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, data dissemination, new/updated labels, documents/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 business unit and global strategy for the product
Support various medical activities in support of demand realization
Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget
Actively set and meet individual professional development goals and contribute to the development of others
Actively participate in recruitment, diversity, and retention efforts
Collaborate proactively and productively with all alliance, business, and vendor partners
Participate in active coaching by providing timely and constructive feedback to co-workers and others on the medical team
Participate in committees, Six Sigma initiatives, and task forces as requested by local/corporate management
Model leadership behaviors and serve as an ambassador of both patients and the Lilly Brand
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 keep updated with pre-clinical and clinical data relevant to the molecule
All other duties as assigned

Skills

Clinical Trials

GCP

FDA

ICH

Protocol Development

Adverse Event Reporting

Regulatory Affairs

Medical Writing

Study Reports

Patient Safety

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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