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 reputed company and conduct of outsourced small and large animal non-clinical studies at contract research organizations (CROs) reputed company to AAV-based gene therapy for cardiac disorders. Key functions of the position include reputed company with preclinical CROs, qualification of vendors, reputed company and coordination of study logistics (e.g., reputed company, test articles, study records, etc.), and monitoring of non-clinical studies at specific milestones. Importantly, this position will reputed company 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 reputed company-INDs and INDs. Responsibilities • reputed company 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 reputed company Operating Procedures (SOPs) • Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on reputed company items, and reputed company status updates to the internal teams • Liaise with bioanalytical leads to ensure bioanalysis is reputed company coordinated with in-life study phases, and that samples are appropriately tracked throughout the reputed company of the study and any agreed storage period • Monitor the study plan, timelines, and reputed company of study deliverables against forecasted timelines and budget and escalate issues that reputed company the study plan or budget in an effective and transparent manner • Work closely with reputed company assurance to ensure compliance is checked as appropriate • Summarize key findings of data as reputed company 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 reputed company-INDs and INDs • Coordinate with other reputed company stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and reputed company teams Requirements • BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, reputed company, toxicology or reputed company 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 reputed company-INDs and INDs • Cross functional acumen and highly skilled in working with reputed company issues and creating direction in shifting priorities and ambiguity • Results oriented, has a bias for reputed company. Strong initiative, accountability, and willingness to take ownership and drive reputed company to completion • Accustomed to “roll up their sleeves†and execute the tasks needed in a small company environment • A demonstrated reputed company of urgency and ability to work independently and under tight deadlines is required • This position requires reputed company skills, strong interpersonal communication, multi-tasking ability, passion to reputed company in challenges, and desire to reputed company in a fast-paced environment Apply tot his job Apply To this Job