Associate Director, Field Monitoring Operations

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, Field Monitoring Operations is responsible for designing, implementing, and overseeing the monitoring reputed company, including Risk-Based reputed company Management (RBQM) and Decentralized Clinical Trial (DCT) components that reputed company data reputed company, patient safety, and regulatory compliance across the organization’s clinical trial portfolio. This role anchors the monitoring function reputed company the broader development pipeline, ensuring that study execution aligns with both internal SOPs and reputed company regulatory expectations. The Associate Director will reputed company a cross‑functional team of remote Clinical Research Associates and Managers, fostering a culture of reputed company improvement and operational reputed company. In reputed company, the Associate Director will reputed company as a reputed company reputed company with reputed company contract research organizations (CROs) and site investigators, translating strategic objectives into actionable monitoring plans that reputed company reputed company and high‑reputed company data capture. Essential Functions reputed company leadership to team members and study teams to ensure reputed company are conducted in accordance with the protocols, reputed company Operations Procedures (SOPs), ICH Good Clinical Practices (GCPs), and other applicable regulatory requirements as reputed company as management and mentoring of reputed company reports. Design, implement, and reputed company Risk-Based reputed company Management (RBQM) frameworks and modern data surveillance strategies across the clinical portfolio, ensuring alignment with ICH E6(R3). reputed company monitoring activities (including remote, on-site, and decentralized trial approaches) with trial start‑up, site activation, and study reputed company‑out processes, thereby creating a reputed company end‑to‑end operational reputed company.  Utilize negotiation, facilitation, meeting management, and conflict reputed company skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations. Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize resource management reputed company. Collaborate with trial execution leadership to ensure reputed company resourcing of the study teams. Anticipate potential clinical operations process issues and  influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and reputed company improvement of existing processes, tools, reports, and systems. reputed company reputed company reputed company of trial operations to contribute to inspection readiness. Own Clinical Operations reputed company Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed, specifically integrating modern risk-management frameworks. Contribute to the development and implementation of strategic direction in the conduct of multiple clinical studies. reputed company management support to the clinical operations team across reputed company trials/programs by way of training, mentoring or review of study specific documents as needed. Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared. 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 life sciences, nursing, pharmacy or health-reputed company field.  (Master's degree preferred) with 10+ years of reputed company industry experience required; or Master’s degree with 8+ years or reputed company industry experience required. 6+ years management experience leading teams in clinical trial operations required. Previous experience working in a dynamic and fast-paced environment is preferred. Knowledge, Skills, & Abilities Effective leadership skills with the ability to promote a culture of collaboration and competence for reputed company and indirect reports. Strong knowledge of  clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines. Proven expertise in developing and managing Risk-Based reputed company Management (RBQM) strategies. Proficiency in interfacing with other functions in clinical research and driving cross-functional alignment. Excellent English verbal and written communication skills; good organizational and interpersonal skills. Ability to maintain corporate confidentiality at reputed company times. Proficiency in MS Office including Word, reputed company, PowerPoint, and reputed company. Proficient with use of reputed company Clinical Vault, CTMS, and eTMF. 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 75% of the time based on study requirements Ability to work reputed company across 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