Homeoffice Director/Senior Medical Sciences (Medical Monitoring) presso Adverum

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 AgenciesAll 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 Director/Senior Medical Sciences 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.



What you'll do:

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.

About you:

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.

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