Preclinical Study Monitor
Redwood City, CA
Research & Development – Non-clinical /
Full Time /
On-site
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 property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team 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.
Adverum Biotechnologies is seeking a highly motivated and experienced Preclinical Study Monitor to manage all aspects of the planning, coordination, and conduct of nonclinical studies conducted at our Contract Research Organization (CRO) partners. This individual will serve as the primary liaison between Adverum and CROs, ensuring studies are conducted in compliance with GLP regulations, study protocols, and company standards.
What you'll do:
- CRO Management & Study Oversight:
- Serve as the single point of contact with CROs, facilitating contracting and protocol development.
- Provide comprehensive oversight of nonclinical study conduct, ensuring adherence to protocols and timelines.
- Coordinate the finalization of study designs, protocol review, and study report cross-functional reviews, working closely with lead scientists.
- Conduct CRO inspections and visits to observe the compliance of procedures with the study protocol.
- Data Management & Reporting:
- Draft subreports of study data when necessary.
- Track deliverables of collected samples, documentation, data, and reports to ensure internal and external alignment and proper coordination of nonclinical studies.
- Review draft reports for completeness prior to finalization. Coordinate revisions and finalization of study reports.
- Responsible for archiving project documents, including nonclinical protocols, reports, data, and study-related documents.
- Maintain accurate and well-organized records and study files.
- Operational Responsibilities:
- Track contracts, purchase orders, and invoices related to nonclinical studies.
- Effectively communicate study progress and potential issues to relevant stakeholders.
- Work collaboratively within Preclinical and Research teams and cross-functionally across the organization.
About you:
- Bachelor’s degree in biological sciences required.
- Minimum 5 years of relevant experience in preclinical study monitoring.
- Previous experience working at a CRO is required.
- Previous experience performing bioanalytical work is plus.
- Solid understanding of drug development, study design, procedures, and documentation practices.
- Proven knowledge of regulatory requirements, guidances, and Good Laboratory Practices (GLP).
- Ability to influence and negotiate effective solutions.
- Ability to work collaboratively within the Preclinical and Research teams as well as cross functionally across the organization to deliver exceptional results and ensure long-term success.
- Excellent organizational, communication, and collaboration skills. Detail-oriented with excellent record-keeping abilities.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Excel, Word, Prism, and PowerPoint.
- Ability to travel occasionally as required.
$124,092 - $133,013 a year
The salary range for this position is $124,092USD to $133,013 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.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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.
