[Hiring] Clinical Research Physician @Lilly

Role Description

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Physician (CRP) participates in:

• The development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product.
• The implementation of global clinical trials.
• The reporting of adverse events as mandated by corporate patient safety.
• The review process for 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.
• Contacts with regulatory and other governmental agencies.
• Outreach medical activities aimed at the external clinical customer community, including thought leaders.
• The development and implementation of the business unit and global strategy for the product.
• Various medical activities in support of demand realization.

The CRP serves as a scientific resource for study teams, departments, and others as needed.

The CRP must ensure compliance with current local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, and Lilly policies and procedures.

Qualifications

• Medical Doctor. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• Minimum of 3 years industry experience in oncology or malignant hematology preferred.
• Demonstrated experience and knowledge of clinical research and the drug development process.
• Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.

Requirements

• Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition.
• Contribute to business unit and global alignment of clinical strategy and clinical plans.
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
• Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions.
• Provide oversight and input into ICDs.
• Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials.
• Review and approve risk profiles to ensure appropriate communication of risk to study subjects.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct.
• Assist in planning process and participate in study start-up meetings.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events.
• Review IIT proposals and publications, as requested by Director-Medical.

Benefits

• Comprehensive benefit program including eligibility for medical, dental, vision and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits and certain time off and leave of absence benefits.
• Well-being benefits including employee assistance program, fitness benefits, and employee clubs and activities.

Company Description

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.