Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.
Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
Tracks study progress, manages budgets, and mentors junior clinical study managers.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.
Provide medical leadership and clinical oversight for physician onboarding, ordering workflows, and clinical experience initiatives.
Serve as a senior physician resource, bridging clinical practice and operational execution to reduce friction in the ordering process.
Partner with cross-functional teams to improve end-to-end clinical and operational processes and drive test utilization and retention.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Lead a small team of Orca-T Account Managers to execute commercial strategy for ORCA T®.
Collaborate cross-functionally with marketing, sales training, and sales operations to maximize teamwork.
Develop and monitor account activity, provide coaching, and ensure compliance.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies for blood cancer patients. They maintain a start-up culture of camaraderie and leadership by example, with a focus on passion, courage, and integrity.
Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
Drive performance management, mentoring, and professional development for direct reports.
Support resource management, adherence to regulations, and continuous process improvements.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.
Manage and motivate a team of CRAs to achieve Precision for Medicine’s quality standards.
Support the career development of the organization’s Clinical Research Associate (CRA) workforce.
Strengthen the quality and productivity of operations within the group.
Precision for Medicine is a Clinical Research Organization with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, and advanced biomarker and data analytics solutions.
Lead clinical development strategy and execution for CAR T-cell therapy trials in autoimmune diseases.
Oversee scientific content of protocols, regulatory documents, and clinical study reports.
Represent Clinical Development with cross-functional teams, KOLs, and external stakeholders.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It fosters a culture of collaboration, innovation, and accountability with a focus on transforming treatment paradigms.
Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.
Translate program strategy into integrated timelines, milestones, and deliverables.
Manage one or more highly complex R&D programs and/or high-profile partnerships.
Lead cross-functional program management activities supporting autoimmune clinical development programs.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Lead strategic market access initiatives that leverage clinical insight, provider behavior, and real-world evidence.
Oversee OncoGenius, the proprietary oncology market intelligence platform, translating provider insights into actionable strategies.
Engage with life sciences clients as a member of the Access Experience Team, providing expert guidance on payer and provider dynamics.
Precision AQ is a life sciences company that provides market access and clinical solutions for oncology therapies. The firm is part of Precision Medicine Group, known for its collaborative culture and specialized expertise in healthcare ecosystem strategy.
Direct and manage a team of Project Directors and Project Managers in global clinical program planning and execution.
Interact with study sponsors as the primary escalation point and optimize profitability of the Project Management organization.
Select, train, develop, and manage talent in project leadership roles, ensuring compliance with SOPs and regulatory requirements.
Precision Medicine Group is a life science company that provides clinical research, data analytics, and commercial services to biopharmaceutical clients. They are a sizeable organization with a focus on quality, people, clients, and performance, fostering a culture of collaboration and continuous improvement.
Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance.
Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, they've built a global team of over 100 employees headquartered in Boston, with a focus on advancing their lead asset. We encourage people from all backgrounds to apply and cultivate a culture where all voices are included.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Prepare and manage operating budgets based on performance and revenue.
Identify research costs and develop multi-year budgets for trials.
Monitor invoices and ensure conformance with budgetary limitations.
Fred Hutchinson Cancer Center is a non-profit organization that provides adult cancer treatment and conducts groundbreaking research on cancer and infectious diseases. They are based in Seattle and have a reputation as one of the world’s leading cancer, infectious disease, and biomedical research centers.
Develop advocacy with key stakeholders and KOLs within the head and neck cancer space, to support the continued success of LOQTORZI.
Lead external engagements and support in-line brand marketing initiatives for LOQTORZI.
Develop a strategic Regional engagement plan in coordination with cross functional partners.
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of novel immuno-oncology therapies. At Coherus, they provide equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment.