Senior Medical Monitor (Senior Director)

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.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team.  Unsolicited resumes sent to Adverum will be considered Adverum's property.   Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

The primary objective for our 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.

• 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.
• 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.
• Providing 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.
• 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 developing 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 pertaining 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 managing 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.

• MD or equivalent, with specialization in ophthalmology
• A minimum of 10-12 years direct experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment 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.

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.