Clinical Research Physician, EMP at Eli Lilly and Company

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), 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 and ensuring compliance with local and international regulations, laws, guidance (e.g., NMPA, ICH, FDA, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and Principles of Medical Research
Alignment with the medical vision

Responsibilities

Participate in the development, conduct, and reporting of clinical trials for new compounds
Implement clinical trials
Report adverse events as mandated by corporate patient safety
Participate in the review process for protocols, study reports, publications, data dissemination, products, new and updated labels, grant submissions, contracts, and contracts with regulatory and other governmental agencies
Serve as a scientific resource for study teams, departments, and others as needed
Contribute to the development of the overall strategy and clinical plan for affiliate development of clinical compounds, focusing on studies required for regulatory submission
Support preparation of high-level plan for phase 2 and 3 studies for early phase to support submission
Collaborate with other scientists (e.g., PK/PD, statistics, ADME, modeling and simulations) to integrate study development
Design and oversee implementation of all clinical pharmacology studies, including understanding unique aspects in healthy volunteers and patient groups
Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research
Design, create, and provide oversight for protocol development
Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements
Collaborate with local clinical research staff, statisticians, and selected consultants and/or investigators in the development of protocols and data collection requirements
Participate in investigator identification and selection, in conjunction with the clinical pharmacology clinical operation group
Review and provide input to risk profiles and local informed consent documents, ensuring appropriate translation and communication of risk to study subjects
Provide oversight ensuring operational team documents completion of administrative requirements for study initiation and conduct (e.g., ethical review board, informed consent, regulatory approval/notification) consistent with GCPs and local laws
Assist in planning process and participate in study start-up meetings and other activities to provide appropriate training and information to investigators and site personnel
Other duties as assigned by line management, primarily related to clinical pharmacology including early phase exploratory and bridging studies for China submissions

Skills

Clinical Research

Clinical Trials

Good Clinical Practices

ICH Guidelines

FDA Regulations

Clinical Pharmacology

Protocol Development

Adverse Event Reporting

Study Reports

Regulatory Compliance

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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