Adverum Biotechnologies

Director

• 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.

Director/Senior Medical Sciences, Medical Monitoring

Controller

• Financial Close: Provide oversight for month end close.
• Review non-standard journal entries for complex transactions & GL account reconciliations of all entities. As part of quarter-end process, review financial statement package & perform flux analyses. Act as main contact with external auditors. Manage quarterly review & annual audits.
• Provide PBC items & address additional requests or questions. Provide guidance to accounting operation team to shorten monthly close cycle to 5 business days & automate processes. Tech.
• Accounting: Monitor & interpret FASB new pronouncements & assess applicability of FASB updates to ADVM. Oversee implementation of new accounting standards.
• Manage technical accounting & processes related to stock-based compensation, leases, capital expenditures, revenue contracts, & clinical trial accruals. Act as owner of stock-based compensation accounting, oversee stock admin for accuracy, proper valuation in equity awards, & prepare quarterly SBC expense pkg.
• Maintain & update accounting policies & procedures per GAAP. Lead SOX compliance efforts.
• SEC Reporting: Managing external financial reporting process, including Form 10-Q/K. Provide financial data for press release in 8-K & SEC filings. Partner with Legal to prepare Annual Proxy Statements. Coordinate with stakeholders of the document to gather updates & assist address review comments. Support VP, Accounting with preparation of quarterly audit committee presentations, disclosure committee, & audit committee reports

Senior Director, SEC Reporting – Assistant Controller

Clinical Research

• Support all phases of clinical research including planning, implementation, completion, and final reports of clinical trials.
• Serve as primary study team contact to manage study start-up, conduct, and close-out.
• Lead cross-functional study execution team to meet project milestones, budgets, and compliance with ICH/GCP and local regulatory authorities.
• Develop, plan, and forecast budget requirements for clinical programs and study sites.
• Manage CRO and vendor evaluation, selection, training, and oversight.
• Facilitate site feasibility and selection processes; conduct sponsor quality monitoring/oversight visits as needed.
• Provide strategic and operational input into study documents (protocol, ICF, CRFs, pharmacy and laboratory manuals).
• Oversight of preparation and submission of safety reports (pharmacovigilance).
• Forecast and manage investigational drug labeling, packaging and distribution; supply chain management.
• Ensure clinical record keeping in preparation for audits and inspections.
• Identify and engage thought leaders, investigators, cooperative groups, and other experts for study design and interpretation.
• In conjunction with data management, assist with eDC development, data listings, issue and query resolution.
• Collaborate on development and set-up of study systems (IVRS/IWRS, site payments and CTMS).
• Develop and report key executional metrics for oversight of clinical trials.
• Assist with creating, reviewing and implementing SOPs and processes in clinical development.
• Ensure documentation is prepared for inclusion in regulatory product submissions.

Director/Senior Medical Sciences, Medical Monitoring

Senior Director, SEC Reporting – Assistant Controller

Senior Clinical Trial Manager