Adverum Biotechnologies

Clinical Research

• Support the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
• Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
• Support cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
• Engages clinical trial vendors to support study start-up activities in line with the clinical trial design
• Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the presence or absence of trends and follow up as appropriate
• Collaborate on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
• Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
• Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

Clinical Scientist – Senior

QA Engineer

• Support a wide variety of GxP activities to support Adverum’s quality compliance initiatives.
• Provide risk-based quality oversight to vendor qualification activities and ensure compliance with internal procedures and documentation.
• Create and manage vendor audit schedules. Conduct audits and interact with vendors to ensure compliance with internal requirements. Ensure vendor packages are complete and inspection ready.
• Assist with executing internal audits and maintaining the internal audit program and ensure compliance with quality objectives and regulatory requirements.
• Assist with regulatory inspections and oversee the inspection readiness plan. Support inspection readiness activities, as directed by QA management.
• Works closely with other functions to assure consistency and implementation of best practices.
• Foster a quality culture and compliance within the team, promoting teamwork, accountability, and continuous learning.
• Perform other responsibilities as assigned by QA management.

QA Compliance Manager – Contract

Project Manager

• Manage functional CMC timelines (e.g. Process Development, External Manufacturing, Quality Control, Quality Assurance, Assay Development), coordinating with functional leads on key tasks to ensure on-track delivery
• Support CMC Lead and functional leads in agenda coordination for team and cross-functional meetings; attend meetings, generating clear minutes with actions and decisions well-documented
• Follow up on action items to ensure progress
• Disseminates and facilitates information flow/exchange among CMC Functions
• Work with team members to escalate constraints, risks, and conflicts via appropriate internal channels
• Provide support for internal reporting, generating materials (e.g. slides, gantt charts, excel sheets) to facilitate discussion and leadership presentations
• Support Research and Non-clinical teams on timelines, ensuring translational work can progress towards GMP Manufacturing and the clinic

Clinical Scientist – Senior

QA Compliance Manager – Contract

Project Manager, CMC – Contract