Senior Director – Medical Monitor, Ophthalmology

🕒 April 16

🇺🇸 United States – Remote

💵 $198k - $389.4k / year

⏰ Full Time

🟠 Senior

👔 Director

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1876

💊 Pharmaceuticals

Pharmaceuticals

Eli Lilly and Company is a pharmaceutical company that engages in the discovery, development, and marketing of products in the pharmaceutical industry. The company's mission is to make life better for people around the world by discovering, developing, and delivering innovative human medicines.

📋 Description

• Provide input into the design and conduct of clinical trials • Reviewing and/or generating key study documents • Assessing and interpreting safety data • Contributing to investigator, other site staff and clinical study team training • Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial • Reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of a clinical trial • Reviewing all adverse events to look for trends or risks • Providing review of study protocols and on-going medical oversight of clinical trials • Consulting with internal and external stakeholders in the development of clinical trial design and conduct • Developing and/or reviewing operational, medical monitoring, and safety plans for studies • Lead and/or participate in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies • Generating safety related documents, to ensure that the reporting of SAEs is current and complete • Responsible for the management of clinical data collection including documentation of product trials and analysis • Manages clinical protocols to support company’s product strategy, data collection, management, and final report development in compliance with appropriate standard operating procedures, regulatory and medical standards.

🎯 Requirements

• Medical Doctor or Doctor of Osteopathy • Must be board eligible or certified in Ophthalmology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring • US trained physicians must have achieved board eligibility or certification • Minimum 5 years of direct experience in medical monitoring and/or clinical development and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required • Proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

🏖️ Benefits

• eligibility to participate in a company-sponsored 401(k) • pension • vacation benefits • eligibility for medical, dental, vision and prescription drug benefits • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts) • life insurance and death benefits • certain time off and leave of absence benefits • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)