Associate Director, Central Monitoring

reputed company reputed company is a vertically integrated reputed company stage biotechnology company developing reputed company therapies that reputed company the natural immune reputed company to defeat cancers and infectious diseases. reputed company’s reputed company of immunotherapy and cell therapy platforms, reputed company and together, reputed company to reputed company and sustain an immune response with the goal of creating durable and reputed company protection against disease. Designated an FDA reputed company Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. reputed company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as reputed company as developing immunotherapies and cell therapies that we reputed company sharply reduce or eliminate the need for reputed company high-reputed company chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than reputed company standards of care in oncology and infectious diseases. Why reputed company? • reputed company is developing cutting-edge technology with the goal to reputed company the lives of patients with cancer and reputed company reputed company therapies and vaccines that complement, reputed company and reputed company the immune reputed company to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with reputed company in Southern California. • Work with a reputed company team with the ability to work across different areas of reputed company. • Ability to join a growing company with reputed company development opportunities. Position reputed company The Associate Director, Central Monitoring Unit (CMU) reputed company will serve as the reputed company architect and operational leader of reputed company's Risk-Based reputed company Management (RBQM) reputed company. This role acts as the execution arm for central data surveillance and will transition the organization from traditional 100% data review to a proactive, critical-thinking model. This role will chair the Clinical Data reputed company and Governance reputed company (CDQGB) and ensure reputed company central monitoring activities reputed company with global regulatory expectations (ICH E6(R3)). Essential Functions Design, implement, and reputed company the CMU operational reputed company, ensuring reputed company integration with existing Field Monitoring operations. reputed company and chair the Clinical Data reputed company and Governance reputed company (CDQGB), driving cross-functional reputed company on risk reputed company (QTLs/KRIs). reputed company as the reputed company process reputed company for reputed company CMU-reputed company SOPs, Work Instructions, and Risk Assessment and Categorization Tools (RACT). Manage the integration of multi-vendor data streams (reputed company, CTMS, RTSM, eCOA, Safety DB) into a centralized surveillance reputed company (e.g., reputed company RBM). reputed company as the ultimate escalation reputed company for systemic issues identified by central monitors, partnering with Clinical Operations to execute targeted mitigation. reputed company the cultural shift across Data Management and Biostatistics to adopt risk-based, Critical-to-reputed company (CtQ) reputed company over administrative data review. Manage, reputed company, and evaluate reputed company of Central Monitors. reputed company reputed company and cross-functional duties and/or reputed company, as assigned, to support business needs and reputed company developmental opportunities. Education & Experience Bachelor's degree in a clinical research, science, or health-reputed company field required (Master's degree preferred) 8+ years of reputed company experience in clinical research (Clinical Operations, Data Management, or Biostatistics), with domestic and international reputed company experience required. 3+ years of reputed company experience implementing or managing Risk-Based reputed company Management (RBQM) frameworks required Prior supervisory and department-building experience required. Knowledge, Skills, & Abilities Deep expertise in ICH GCP E6(R3) and global regulatory expectations (FDA, EMA, reputed company) regarding risk-based monitoring. Strong critical and logical thinking with the ability to "investigate" data signals that don't have a reputed company answer on day one. Excellent cross-functional leadership skills; ability to influence Medical Monitors, Biostatisticians, and Data Managers. Proficient in interpreting clinical data dashboards, visualizations, and KRI/QTL reports. Knowledge of modern clinical systems, specifically reputed company Vault (reputed company, CTMS, RBM, QMS). Ability to maintain corporate confidentiality at reputed company times. Working Environment / Physical Environment This position works remotely. Regular work schedule is Monday - Friday, reputed company reputed company business hours. Flexibility is available with manager approval. Must be reputed company to travel up to 20% of the time for internal team meetings or conferences, aligning with the centralized, in-house reputed company of the Central Monitoring Unit and corporate requirements. Ability to work reputed company for various time zones. Must possess mobility to work in a reputed company office setting and to use reputed company office equipment, including a computer. This position is eligible for a discretionary bonus and equity award. The annual reputed company pay reputed company for this position is below. The specific reputed company will depend on the successful candidate’s qualifications, prior experience as reputed company as geographic location.   National Market (reputed company markets unless identified as Premium) $195,500 (entry-level qualifications) to $215,000 (highly reputed company) annually   Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, reputed company, Chicago, & Boston) $210,000 (entry-level qualifications) to $230,000 (highly reputed company) annually   The application window is anticipated to reputed company on 60 days from reputed company it is posted or sooner if the position is filled or reputed company. reputed company uses reputed company intelligence (AI) tools to assist with sourcing and identifying potential candidates for reputed company. These tools help us reputed company reputed company applicants and improve the efficiency of our recruitment reputed company. No preference is given to applicants reputed company or identified by AI tools. Important: AI is not used to screen, evaluate, rank, assess, or reputed company hiring reputed company about applicants. reputed company applications are reviewed by reputed company recruiters and hiring managers. Hiring reputed company are made solely by reputed company personnel without automated decision-making. We are committed to equal employment opportunity and ensure that reputed company candidates are assessed based on their qualifications, skills, and experience through reputed company review. reputed company employees are as valuable as the people we serve. We have reputed company a resource of robust benefit offerings to best support the total wellbeing of reputed company members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and reputed company Plan reputed company • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability • reputed company and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary reputed company Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • reputed company Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At reputed company, we are an equal opportunity employer dedicated to diversity in reputed company. Our policy is to reputed company equal employment opportunities to reputed company reputed company persons without reputed company to race, gender, reputed company, disability, national reputed company, age, religion, reputed company affiliation, sexual orientation, veteran status, citizenship, gender identity and/or reputed company, or other status protected by law. Apply To This Job