Director/Senior Medical Sciences, Medical Monitoring

Job not on LinkedIn

November 7

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $279.5k - $367.3k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Adverum Biotechnologies

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Biotechnology • Pharmaceuticals

Adverum Biotechnologies is a company focused on developing gene therapies to treat debilitating ocular diseases. Their mission is to establish gene therapy as a new standard of care, particularly in treating conditions like wet age-related macular degeneration (wet AMD), which is a leading cause of blindness globally. The company is advancing their investigational gene therapy Ixo-vec, designed to provide a long-lasting treatment through a single in-office administration, which could replace the current standard of frequent and painful eye injections. By leveraging their proprietary adeno-associated virus (AAV) vector platform, Adverum aims to transform the standard of care, improve accessibility to treatment, and achieve significant societal impact by restoring vision and preventing blindness.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

💰 $217M Post-IPO Equity on 2020-08

📋 Description

• 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.

🎯 Requirements

• Must have a MD or equivalent required with Board Certification in Ophthalmology (preferred) or subspecialty and a current California medical license. • You 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. • You are proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

🏖️ Benefits

• medical • dental • vision • 401k • STD/LTD • life and accident insurance • either paid time off or flexible paid time off