Director/Senior Director - Medical Monitor

Lilly•Indianapolis, IN

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The primary objective for our Medical Director/Senior (Medical Monitor) is to provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training.

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. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see: PLA: Medical Licensing Information and Medical Education | MBC
Minimum of 10 years direct experience in medical monitoring 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.

Responsibilities

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, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
Providing review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
Ensuring activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations.
Consulting with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments.
Developing and/or reviewing operational, medical monitoring, and safety plans for studies.
Leading and/or participating 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, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
Writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
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.
May also be responsible for determining whether a product accomplishes the goal for which it was produced.
Experienced in industry with expertise in the areas of drug development, operations, and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch.
Supports new and ongoing clinical research and clinical trials and ensures efficient and timely processing of confidentiality agreements and clinical agreements.
Trains clinical research team members and evaluates their performance.
Selects, develops, and evaluates personnel to ensure the efficient operation of the function.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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