Associate Director of Clinical Operations

🍊 Join Our Mission Revolutionizing Clinical Trials at Lindus Health. We are committed to accelerating the development of new treatments through innovative and efficient clinical trials. In a landscape where outdated practices lead to increased costs and delays, we are reshaping the future of drug development to ensure patients gain access to life-saving the…

Role Overview Acadia Pharmaceuticals is hiring an Associate Director of Clinical Operations. This position is based in either Princeton, New Jersey or San Diego, California. The Associate Director will guide key phases of clinical trials, focusing on high-quality execution and adherence to regulatory requirements. What You Will Do Lead and oversee essential stages of clinical trial operations Ensure all activities meet regulatory and company standards Promote effective collaboration across multiple teams Drive project timelines to support company objectives Take a hands-on approach to managing clinical operations

Join Revolution Medicines, Inc. as an Associate Director of Clinical Operations, where you will play a pivotal role in advancing the development of innovative therapies. This leadership position will involve overseeing clinical trial management, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success.

Nuvalent seeks an Associate Director of Clinical Operations to join the team in Cambridge, MA or work remotely. This leadership role guides the execution of clinical trials, ensuring every step aligns with regulatory standards and internal protocols. The position partners with cross-functional teams to develop and deliver on clinical strategies, overseeing studies from planning through closeout. What you will do Direct clinical trial operations for multiple concurrent studies Maintain compliance with all regulatory requirements and company procedures Work closely with colleagues across departments to create and implement clinical strategies Supervise all aspects of study management, from initiation to completion Oversee budgets, timelines, and resource planning for clinical programs Mentor and guide junior staff within clinical operations Requirements Significant experience in clinical operations and project management Background working in pharmaceutical or biotechnology organizations Demonstrated ability to manage budgets and timelines Experience mentoring or managing team members

Role overview The Associate Director of TMF Operations & Clinical Operations Analytics at TGS leads a remote team dedicated to strengthening trial master file (TMF) operations and advancing analytics within clinical operations. This position focuses on upholding compliance, quality, and efficiency throughout clinical trial activities. Main responsibilities Supervise all TMF processes to ensure accurate clinical trial documentation and maintain data integrity. Work closely with cross-functional teams to keep TMF management aligned with regulatory standards. Coordinate audit activities and maintain readiness for regulatory inspections. Lead initiatives that enhance TMF operations and introduce best practices across the team. Evaluate clinical operations data to uncover insights that support decision-making and drive process improvements. What success looks like TMF operations consistently meet compliance requirements and function efficiently. Audits and inspections are handled with thorough preparation and effective management. Analytics from clinical operations guide strategies and contribute to improved performance. Remote work This position is fully remote.

Join 4D Molecular Therapeutics as an Associate Director of Clinical Operations and play a pivotal role in leading innovative clinical trials that pave the way for groundbreaking therapeutic approaches. This position is fully remote, allowing you to collaborate with a dynamic team dedicated to advancing gene therapy solutions.

We are seeking an experienced and dynamic Associate Director of Clinical Operations to join our team at Revolution Medicines. In this pivotal role, you will lead the planning, execution, and management of clinical trials, ensuring alignment with regulatory guidelines and company objectives. You will work closely with cross-functional teams to deliver innovative therapies to patients.

Definium Therapeutics, previously known as Mind Medicine, is a pioneering biopharmaceutical company in the clinical stage, focused on developing innovative product candidates aimed at addressing brain health disorders. Our vision is to lead globally in creating and delivering treatments that enhance patient outcomes. We are actively building a pipeline of groundbreaking product candidates that target neurotransmitter pathways crucial for brain health, encompassing both acute perceptual effects and non-perceptual modalities.Founded in 2019, we are on a trajectory of rapid expansion, continuously enhancing our global presence. We are in search of dynamic, high-impact individuals across various clinical, technical, and business operational domains to bolster our team of intelligent, patient-centered professionals.The Associate Director of Clinical Operations is responsible for overseeing trial-level operations within the organization. This role requires operational expertise to ensure the successful cross-functional delivery of assigned global clinical trials, adhering to agreed timelines and budgets while complying with all relevant SOPs and regulatory standards. The ADCO will oversee external service providers, manage the planning and execution of both internally and externally managed trials, from the initial protocol synopsis to the availability of the Clinical Study Report (CSR) and appropriate trial result disclosures.The ADCO leads the cross-functional Trial Team (CTT), engaging with all team members to construct the trial operational plan, and is jointly responsible with the Study Clinician and Clinical Scientist for managing external service provider contracts and budgets, ensuring alignment with organizational goals. This role provides operational leadership for trial execution, defines risk mitigation strategies, and ensures their implementation.Key Responsibilities:Lead the cross-functional Trial Team (CTT), monitoring project deliverables and timelines. Proactively manage to ensure milestones are achieved, identifying risks and implementing mitigation strategies.Ensure the trial is delivered within the agreed/projected budget. Manage trial budget accurately, including updates for scope changes and reconciliation of trial costs. Oversee trial-level contract management, including review and approval of contracts and change orders to ensure compliance with service delivery.Provide leadership for trial implementation, driving feasibility assessments and ensuring all operational aspects align with strategic objectives.

Oruka Therapeutics is developing biologics designed to change the treatment landscape for chronic skin conditions such as plaque psoriasis. The company focuses on long-lasting relief for patients, aiming for outcomes like disease clearance with infrequent dosing. Their pipeline includes proprietary antibodies created by Paragon Therapeutics, targeting the underlying causes of dermatologic and inflammatory diseases. More details about their work can be found at www.orukatx.com. Role overview The Associate Director of Clinical Operations will manage the setup and execution of clinical trials, supporting the Director of Clinical Operations within a specific therapeutic area. This position oversees multiple studies, combining strategic planning with day-to-day operational involvement to keep clinical programs on track and within budget. Responsibilities include handling operational details, anticipating challenges, and implementing solutions to ensure trial progress. The role requires someone who can move between leadership and hands-on work, maintaining a player/coach mindset throughout. What you will do Oversee all phases of clinical trial setup and execution across several studies Support the Director of Clinical Operations in a designated therapeutic area Balance strategic planning with direct, hands-on involvement in daily operations Identify and resolve operational challenges to maintain study timelines and budgets Requirements Demonstrated integrity and sound judgment in clinical operations Ability to shift between high-level oversight and direct involvement as needed Strong commitment to study goals and a collaborative approach Adaptability and resourcefulness in a biotech setting This hybrid role is based in Waltham, Massachusetts, with an expectation of three days onsite each week. The team values learning, growth, and a positive, inclusive culture.

Role overview TransPerfect is seeking an Associate Director, TMF Operations & Clinical Analytics to join the Clinical Science and Medical Affairs group. This fully remote role reports to the Clinical Operations Leadership Team. The focus is on providing strategic oversight for Trial Master File (TMF) operations, with an emphasis on improving process functionality, efficiency, scalability, and quality. Key responsibilities Direct the TMF support model, managing both processes and systems Oversee TMF vendor relationships and manage associated processes Act as the primary contact for all TMF-related activities Develop and implement global TMF standards, standard operating procedures (SOPs), and controlled documents in line with regulations and industry expectations Maintain inspection readiness and coordinate support for audits and regulatory inspections Provide expert input on clinical documents, particularly study plans Analyze and present TMF metrics and KPIs to leadership to demonstrate TMF health Lead updates and improvements to the TMF support model Negotiate TMF vendor budgets and manage operational expenditures Requirements Significant experience with TMF systems and processes Proven background in vendor management Thorough understanding of inspection readiness and audit support Ability to oversee reporting, metrics, KPIs, and analytics for Clinical Operations Strong collaboration skills with senior leaders and stakeholders to deliver meaningful reports that support performance measurement and continuous improvement Remote work This position is fully remote.

The Associate Director of Clinical Operations Compliance & Training at Revolution Medicines focuses on upholding compliance and supporting training programs within clinical operations. This role is based in Redwood City, California. Role overview This position centers on maintaining the integrity of clinical operations by ensuring regulatory standards are met. The Associate Director will guide training efforts and help reinforce consistent practices across teams. Key responsibilities Oversee compliance activities related to clinical operations Lead and coordinate training initiatives for staff Promote adherence to regulatory requirements and internal policies Work environment This role operates within a biotechnology setting where attention to detail and commitment to regulatory standards are essential.

Join Middlebury College as the Associate Director of Counseling for Clinical Operations, a pivotal role that enhances the mental health services provided to our diverse student body. You will oversee clinical operations, ensuring the delivery of high-quality counseling services while fostering an inclusive environment that supports student well-being.

Role Overview:The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.Key Responsibilities:Program Strategy & Leadership (35%)Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.Clinical Trial Oversight (25%)Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.Regulatory & Documentation Support (15%)Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.Vendor & CRO Management (15%)Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.Team Development & Collaboration (10%)Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.Other duties as assigned.

Role Overview Karius, Inc. is hiring a Director of Clinical Operations to strengthen clinical processes and uphold high standards across services. This leadership role calls for a strategic approach and deep experience in clinical operations. The Director will focus on refining workflows and supporting improved patient outcomes. Location This position is based in Redwood City, CA with a hybrid schedule, or can be performed remotely within the United States.

We are seeking a highly skilled and dynamic Director/Manager of Clinical Operations to lead our clinical initiatives at Integrated Resources, Inc. This pivotal role requires a strategic thinker with extensive experience in clinical operations, who can drive performance and enhance patient care. You will be responsible for overseeing clinical activities, developing operational strategies, ensuring compliance with regulations, and fostering a collaborative environment among clinical teams.

Sylvan Health seeks a Director of Clinical Operations to advance the integration of nutrition into both primary and specialty care. This is a fully remote position based in Oregon. The Director will shape and expand Sylvan Health’s clinical delivery model. Reporting to the Senior Vice President of Operations, this leader manages the Registered Dietitian network and oversees the systems, workflows, and metrics that drive patient engagement and quality care. The role calls for a blend of clinical operations expertise, technology fluency, management skill, and data analysis. Collaboration is central. The Director works closely with Clinical, Growth, Operations, and Customer Success teams to ensure a strong experience for patients and providers. The position covers the full process of delivering, measuring, and improving nutrition services. Key responsibilities Design and scale Sylvan Health’s clinical delivery model Oversee the Registered Dietitian network, including systems and workflows Set and track performance metrics to support quality care and patient engagement Work cross-functionally to deliver a consistent care experience Use data to guide improvements and support growth Requirements Background in clinical operations and care management Experience in startup or rapidly growing environments preferred Understanding of clinical workflows and operational frameworks Ability to scale organizations and build new processes Comfort with data and leading teams toward company goals Clear communicator who values a people-focused approach

Join Our MissionBecome a pivotal part of our innovative team that is revolutionizing musculoskeletal care. As the Director of Clinical Operations, you will spearhead our clinical operations and report directly to the Vice President. Your leadership will be instrumental in enhancing our care team as we innovate care delivery through cutting-edge technology. You will drive initiatives aimed at improving efficiency, including technology adoption and performance enhancements across health coaches, physical therapists, and other team members. Your role will ensure uniformity across all processes, fostering member safety, engagement, service excellence, and clinical integrity.Key ResponsibilitiesOperational Strategy Execution: Transform strategic objectives into actionable operating plans and procedures, leveraging data-driven insights to uncover opportunities. You will oversee the operational framework for the organization, ensuring effective communication, clear ownership structures, and comprehensive outcomes reporting.Enhancing Organizational Performance: Partner with Clinical Operations leadership to streamline processes, expedite decision-making, boost accountability, and elevate talent density.Achieving Business Goals: Consistently meet service level agreements and business outcomes (revenue, experience, quality, finances) through a robust operating system and technology-enabled workflows. You will drive performance improvements and minimize variations to achieve or surpass targets.Innovation Leadership: Champion the integration of technology and advanced clinical practices as we innovate our AI-driven care delivery model. You will identify and implement system designs and automation to scale operations and enhance the experiences of both care teams and members.Commitment to Service Excellence: Guide program and service delivery modifications across the care team, ensuring a consistent, high-quality experience for members that aligns with our product offerings.Your ProfileStrategic Leader: Proven track record of operational excellence, adept at navigating through uncertainty and driving organizational change.Team Builder: Experience in developing and leading large service delivery teams, with a strong focus on coaching and mentoring to foster high employee engagement.Continuous Learner: Eager to explore new methodologies and approaches, remaining adaptable in a dynamic environment.

About IntusCareIntusCare is pioneering an all-encompassing ecosystem designed to empower Programs of All-Inclusive Care for the Elderly (PACE). Our innovative solutions help PACE programs enhance care quality, optimize financial performance, and ensure compliance. By replacing outdated technologies and cumbersome manual processes, we provide tailored tools for care coordination, risk adjustment, population health, and utilization management. Our mission is to enable teams to take charge of their operations and improve health outcomes for dual-eligible seniors, who represent some of the most vulnerable and complex individuals in the U.S. healthcare system.OverviewAs the Director of Clinical Operations, you will provide operational leadership and strategic direction across our clinical service lines, including population health, utilization management, and corporate compliance. Reporting directly to the Chief Population Health Officer (CPHO), you will drive scalable service delivery, oversee daily operational performance, and collaborate closely with Product and Engineering teams to transform service line requirements into clear technical specifications.This role requires a highly collaborative leader who excels in dynamic environments, constructs scalable systems, and effectively represents population health leadership to various stakeholders. The ideal candidate will possess substantial experience in population health and value-based care, coupled with robust operational expertise, although a clinical license is not a prerequisite.Key ResponsibilitiesDefine and enhance the clinical service delivery model to facilitate company expansion, scalability, and sustainable margins.Create and sustain a multi-year roadmap for scaling clinical services across people, processes, technology, and analytics.Oversee the comprehensive performance and operational health of clinical services.Develop and implement scalable workflows, operating procedures, and quality assurance frameworks.Establish capacity planning models and workforce forecasts aligned with anticipated growth and service demand.Design the clinical workforce architecture, optimizing role structures, scope of practice, and staffing ratios.

Noom is dedicated to empowering individuals to lead healthier, longer lives. As an innovative digital health company, we connect our users with valuable content, personalized coaching, community support, and medical professionals to foster sustainable health habits. Our organization thrives on a foundation of scientific research, cutting-edge technology, and exceptional talent, ensuring that every team member can witness the meaningful impact of their contributions.About the RoleAs part of our expansion, we are looking for a Senior Director of Clinical Operations to spearhead and enhance our clinical operations division. Reporting directly to the SVP of Health Operations and Customer Experience, you will inherit a dedicated team and an active portfolio of initiatives, while also creating new strategies. You will be responsible for overseeing clinical protocols, managing vendor relationships, and developing operational frameworks that bring Noom’s clinical programs to fruition for both B2B and direct-to-consumer markets.Your ResponsibilitiesOversee the comprehensive clinical operations organization for Noom Med, facilitating strategic growth in clinical programs, protocol development, and the execution of new initiatives alongside Product and Engineering teams.Act as the operational liaison between clinical strategy and implementation, ensuring that commitments to members and enterprise partners are met with excellence, accuracy, and quantifiable results.Build and lead a high-performing clinical operations team, managing recruitment strategies and headcount as the company scales.Drive the execution of clinical programs across D2C and B2B initiatives, fostering collaboration among internal clinical teams, external provider networks, and vendor partners.Ensure a positive provider and member experience, prioritizing provider satisfaction, clinical quality, and member health outcomes as key performance indicators.Establish and maintain the operational infrastructure that supports the clinical organization, including capacity models, utilization targets, reporting systems, and workflow processes that adapt to growth.Continuously evolve your role and responsibilities to meet the demands of Noom Med's expansion.

Company Overview Avalyn Pharma is innovating the landscape of pulmonary fibrosis treatment through a groundbreaking pipeline of inhaled formulations. These approved medications are expertly designed to minimize systemic exposure and deliver targeted therapy directly to the affected areas. Pulmonary fibrosis, characterized by lung tissue scarring, diminishes lung function and quality of life, contributing to increased mortality rates. Conventional therapeutic options may slow disease progression but often come with significant toxicities that limit their application. Avalyn’s inhaled approach directly addresses the underlying causes of pulmonary fibrosis, aiming to enhance patient outcomes with reduced systemic side effects. Currently, Avalyn’s AP01, an optimized inhaled formulation of pirfenidone, is under investigation in the MIST Phase 2b study for progressive pulmonary fibrosis (PPF). This formulation has demonstrated clinical proof-of-concept with better efficacy and safety profiles compared to existing treatments, having been evaluated in over 150 patients with various forms of pulmonary fibrosis. Furthermore, Avalyn has completed two Phase 1 studies for AP02, an inhaled formulation of nintedanib for idiopathic pulmonary fibrosis (IPF), with plans for a Phase 2 clinical trial in the works. For more details, please visit avalynpharma.com and follow us on LinkedIn.