Manager/Senior Manager, Non-Clinical Operations

About the position The Manager/Sr. Manager, Non-Clinical Operations role will report to the Director, Translational Science and Clinical Biomarker (TSCB). The TSCB team is comprised of drug development scientists representing pharmacology, toxicology, non-clinical bioanalytics and clinical biomarker development and operational support. This position will support operational oversight and conduct of outsourced small and large animal non-clinical studies at contract research organizations (CROs) related to AAV-based gene therapy for cardiac disorders. Key functions of the position include direct interactions with preclinical CROs, qualification of vendors, oversight and coordination of study logistics (e.g., contracts, test articles, study records, etc.), and monitoring of non-clinical studies at specific milestones. Importantly, this position will interface with Medical Writing and liaise with contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs. Responsibilities • Lead work plans (SOWs) by working with department leaders, key stakeholders and CROs following the principles of Good Laboratory Practices (GLPs/21 CFR 58), where applicable, and company Standard Operating Procedures (SOPs) • Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on action items, and provide status updates to the internal teams • Liaise with bioanalytical leads to ensure bioanalysis is well coordinated with in-life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period • Monitor the study plan, timelines, and progress of study deliverables against forecasted timelines and budget and escalate issues that impact the study plan or budget in an effective and transparent manner • Work closely with quality assurance to ensure compliance is checked as appropriate • Summarize key findings of data as well as relevant scientific publications in presentations for internal review • Work closely with Medical Writing and contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs • Coordinate with other internal and external stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and Accounting teams Requirements • BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences or equivalent • Experience in AAV gene therapy products for minimum of 2 years • Working knowledge of GLP and ICH guidelines • Experience managing studies and authoring non-clinical sections of regulatory documents, particularly pre-INDs and INDs • Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity • Results oriented, has a bias for action. Strong initiative, accountability, and willingness to take ownership and drive projects to completion • Accustomed to “roll up their sleeves†and execute the tasks needed in a small company environment • A demonstrated sense of urgency and ability to work independently and under tight deadlines is required • This position requires collaborative skills, strong interpersonal communication, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment Apply tot his job