Job Description

Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. What you’ll do Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial. Review and analyze the eligibility of participants per inclusion/exclusion requirements of a clinical trial. Review 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. Provide review of study protocols and ongoing 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. Ensure activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations. Consult with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments. Develop and/or review 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. Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. About you Must have an MD or equivalent with Board Certification in Ophthalmology (preferred) or subspecialty and a current California medical license. Have a minimum of 5-7 years direct experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a pharmaceutical, clinical trial environment or CRO required. Be proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as medical terminology, clinical trials, and clinical research. Salary The salary range for this position is $279,473 USD to $367,339 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off. Inclusion and Diversity At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space that allows for everyone in our Adverum Community to not only feel safe but also encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation. #J-18808-Ljbffr Adverum Biotechnologies, Inc.

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