Lead end-to-end TMF strategy, including transition from outsourced to in-house operations.
Ensure TMF health and inspection readiness through governance, quality control, and metrics.
Serve as TMF subject matter expert and partner cross-functionally for document flow and compliance.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The company is guided by core values of collaboration, innovation, and ownership, and is committed to transforming treatment for autoimmune disease.
Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
Manage validation of analytical methods and stability programs to support clinical trials.
Investigate laboratory deviations and ensure risks are managed to resolution.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.
Develop and execute strategic account plans across health systems, IDNs, and treatment centers.
Lead treatment center activation, onboarding, contracting, operational readiness, and site certification.
Serve as the primary customer contact for CAR-T/cell therapy operations, logistics, and order management.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases. The company is guided by core values and is committed to transforming the future of treatment for autoimmune disease.
Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.
Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.
Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.
AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out.
Lead sponsor-side CRO and vendor management across the full study lifecycle.
Translate study requirements into operational plans and drive study-level strategic decision-making.
Oura empowers people to own their inner potential with award-winning products that provide insights into readiness, activity, and sleep quality. As a quickly growing company, we focus on helping people live healthier and happier lives, ensuring our team members have what they need to do their best work.
Manage clinical elements of trials including site selection, start-up, enrollment, monitoring, and close-out for studies across multiple countries.
Lead CRAs and ensure timeline adherence, quality delivery, and effective communication with cross-functional teams and sponsors.
Identify risks to project timelines, create action plans, and mentor team members while maintaining focus on study priorities.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, biomarker and data analytics, with a focus on rare diseases and oncology. The company is part of Precision Medicine Group, a growing organization dedicated to advancing oncology development and positively impacting patient health.
Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.
Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.
Lead integrated asset strategy across the full product lifecycle, from research through commercialization.
Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
Partner cross-functionally with Research, Clinical, Regulatory, and Commercial teams to ensure alignment and execution.
Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values, the company is committed to transforming treatment for autoimmune disease.
Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
Lead and mentor a team of CRAs and clinical trial logistics personnel.
Develop and implement processes and tools for high-quality trial management.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
Ensure CTMs have proper resources and training to deliver high-quality study conduct.
Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.
Serve as the Clinical Scientist for one or more Phase 2/3 studies, contributing to study design, protocol development, and oversight.
Lead data review and medical monitoring activities, identifying trends, deviations, and safety signals in collaboration with Medical Monitors.
Support regulatory submissions, cross-functional partnerships, and scientific publications to advance clinical development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a growing company with a collaborative, fast-paced environment where individual contributions have significant impact.
Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
Collaborate with investigators and site teams to maintain study integrity and operational excellence.
Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.
Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.