Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
Senior Medical Monitor (Senior Director) image - Rise Careers
Job details

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.


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.
  • 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.


About you:
  • 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.


$305,000 - $327,000 a year
The salary range for this position is $305,000 USD to $327,000 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. The amount of incentive varies and is subject to the terms and conditions of the 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.

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.

Average salary estimate

$316000 / YEARLY (est.)
min
max
$305000K
$327000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs
Photo of the Rise User
Posted 8 days ago

Join AbbVie as a Senior Scientist II, where you will develop and implement cutting-edge analytical methods for complex biologics.

Photo of the Rise User

As a Senior Clinical Development Medical Director, you will guide strategic clinical initiatives within our oncology team for Novartis in East Hanover.

Photo of the Rise User
Eurofins Hybrid Easton, MD 21601, USA
Posted 13 days ago

Join Eurofins as a Microbiologist and contribute to ensuring product safety and quality through rigorous scientific testing.

Photo of the Rise User

Join AbbVie as a Principal Research Scientist I to lead a dynamic team driving innovative drug development solutions.

ngc Hybrid United States-California-Woodland Hills
Posted 2 days ago

Join Northrop Grumman as an AMO Physicist and help advance technology in quantum sensing solutions for global security.

Photo of the Rise User

Seeking a dynamic Principal Research Scientist I to drive innovative analytical strategies at AbbVie.

Photo of the Rise User

Join CHAI as a Manager in the Women’s & Newborn Health team, focusing on innovative strategies to improve health outcomes in underserved populations.

Photo of the Rise User
Posted 5 days ago

Join Kelsey-Seybold Clinic as a Chief Physicist in Radiation Oncology to lead and innovate in providing exceptional radiation treatment care.

Photo of the Rise User
Posted 8 days ago

Join AbbVie as an Associate Scientist to contribute to groundbreaking research and innovative solutions in healthcare.

Photo of the Rise User
Posted 7 days ago

Join LLNL as a Postdoctoral Researcher to innovate in the field of RF photonics and collaborate with top scientists.

Photo of the Rise User
Posted 21 hours ago

Join AbbVie as a Senior Scientist II to drive peptide therapeutic innovations within the Immunology Discovery organization.

Photo of the Rise User
Posted 7 days ago

Seeking an experienced Director II of Clinical Development to lead our aesthetic clinical programs at AbbVie in Irvine, CA.

Photo of the Rise User
Posted 5 days ago

Join AbbVie as a Postdoctoral Fellow focusing on computer vision to advance AI methodologies in drug development.

Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a on...

20 jobs
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 4, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
Photo of the Rise User
Someone from OH, Cincinnati just viewed Group Facilitator - Outpatient at Discovery Behavioral Health
B
Someone from OH, Lima just viewed Head of Digital Acquisition at Booksy