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• Lead and oversee complex clinical trial operations from initiation through closeout.
• Serve as primary operational contact for industry-sponsored trials, ensuring quality and compliance.
• Mentor clinical operations managers and drive process improvements across projects.

This is a clinical research organization managing industry-sponsored trials and providing endpoint and specialty services. It emphasizes collaboration, flexibility, and operational excellence in a remote-first environment.

• Lead Kailera's end-to-end clinical and commercial supply chain, ensuring reliable delivery of investigational and commercial drug products.
• Build and develop a high-performing global supply chain team, establishing governance, partnerships, and performance metrics.
• Set global supply strategy and oversee logistics, compliance, systems, and budget to scale with company growth.

Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence.

• Lead clinical research project planning, execution, and delivery, ensuring regulatory compliance and quality.
• Coordinate cross-functional teams and manage timelines, budgets, and study documentation.
• Serve as the primary sponsor and client contact, providing regular project updates and resolving issues.

Alimentiv is a global CRO advancing therapies for gastrointestinal diseases, with deep expertise in IBD drug development. With about 700 employees across multiple countries, it is a private, profit-with-purpose company focused on scientific research and its people.

• Implement and optimize REMS and specialty pharmacy workflows for COMP360 in the U.S.
• Manage vendor relationships, compliance metrics, and cross-functional collaboration.
• Support launch readiness, audits, and continuous process improvement.

Compass Pathways is a biotech developing COMP360 psilocybin for treatment-resistant depression and PTSD, with FDA Breakthrough Therapy designation. Headquartered in London with a U.S. office in New Jersey, it focuses on patient-centered mental health innovation.

• Lead Clinical Trial Supply activities across the study lifecycle ensuring compliant supply.
• Manage IMP forecasting, packaging, labeling, and distribution with internal teams and vendors.
• Oversee vendor management, contract negotiations, and documentation for trials.

Immunic Therapeutics is a biotechnology company focused on clinical research and development. The company fosters a diverse and inclusive workplace culture with an emphasis on equity and collaboration.

• Coordinate planning, implementation, and delivery of device logistics projects for eCOA clinical trials.
• Oversee budgets, deployment plans, and risk mitigation while collaborating with clinical teams and stakeholders.
• Ensure inventory management, mobile device management, and global shipping are completed on schedule and within scope.

The hiring company is a life sciences organization specializing in device logistics and electronic clinical outcome assessments for clinical trials. They foster a collaborative, cross-functional remote culture aligned with US East Coast time zones.

• Independently manage assigned clinical trial activities in compliance with GCP and regulations.
• Oversee essential study documentation, TMF completeness, and study trackers.
• Manage vendors, CTMS activities, and cross-functional coordination to ensure compliant study execution.

Cognito Therapeutics is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, including an investigational therapy for Alzheimer's disease. The company is an interdisciplinary team united by a shared purpose of protecting and progressing the human ability to think, learn and remember.

• Build and lead a clinical supply consulting and advisory practice, developing repeatable offerings, methodologies, and delivery standards.
• Advise sponsors on complex supply decisions, including forecasting, inventory strategy, and risk mitigation, and convert complex data into clear actions.
• Shape product strategy by translating market needs into scalable capabilities and driving commercial growth through thought leadership.

Endpoint is an interactive response technology (IRT) systems and solutions provider that helps sponsors and pharmaceutical companies achieve clinical trial success through its proprietary PULSE® platform. Headquartered in Raleigh-Durham, North Carolina, the company has offices across the United States, Europe, and Asia.

• Support the planning, coordination, and delivery of clinical research studies.
• Collaborate with sponsors, cross-functional teams, vendors, and clinical sites to ensure studies meet timeline, budget, and quality targets.
• Manage project milestones, site activation, patient recruitment, and risk mitigation in a remote working environment.

Jobgether is an AI-powered job matching platform connecting candidates with hiring companies. The hiring partner is a science-driven clinical research organization offering a collaborative remote environment.

• Lead end-to-end clinical trial operations, ensuring compliance with GCP and regulatory standards.
• Manage study start-up, regulatory submissions, TMFs, budgets, and cross-functional collaborations.
• Drive risk mitigation and continuous improvement across clinical development programs.

This company is a clinical development organization focused on delivering high-quality clinical trials and advancing patient care. Its collaborative team of motivated professionals works remotely across the US with a strong emphasis on innovation and continuous improvement.

• Lead CMC workstream planning across multiple development programs, from technical development through regulatory submission.
• Build integrated CMC timelines in Smartsheet and coordinate with CDMO partners on tech transfers and manufacturing.
• Manage risks, budgets, and cross-functional technical operations teams to drive decisions and ensure on-time delivery.

Kailera is a biopharmaceutical company developing novel therapies for obesity and related conditions. It fosters an entrepreneurial, team-oriented culture and is committed to building an inclusive workplace.

• Lead global clinical study delivery, overseeing project management and finance teams to execute full-service trials.
• Drive operational planning, resource allocation, and financial risk oversight as part of senior leadership.
• Represent project operations with sponsors and business development, ensuring quality, compliance, and best practices.

Alimentiv is a global contract research organization focused exclusively on advancing therapies for gastrointestinal diseases, supporting over 70% of IBD compounds in development. With approximately 700 employees across multiple countries, it operates as a private, profit-with-purpose company investing in research, technology, and its people.

• Manage and scale ShipBob's most strategic merchant partnerships as the program lead.
• Partner with fulfillment center teams to ensure SLAs, escalations, and process improvements are handled with speed and accountability.
• Lead cross-functional initiatives and serve as a trusted advisor to executive stakeholders, driving growth and operational performance.

ShipBob is a leading global supply chain and fulfillment technology platform for SMB and mid-market ecommerce merchants, providing access to best-in-class fulfillment capabilities. Backed by prominent investors, it is one of the fastest-growing tech companies in Chicago with a high-performance culture focused on ownership and collaboration.

• Lead planning, execution, and integrated governance for Future of Medicine initiatives across Clinical Conduct, Quality, Technology, and Operations.
• Translate clinical, operational, quality, and program needs into scalable workflows, requirements, SOPs, and training.
• Drive readiness, change planning, and sustained adoption of new program requirements and technology capabilities.

Care Access brings world-class clinical research and health services to communities facing barriers to care through hundreds of research locations, mobile clinics, and global clinicians. The company values an inclusive culture where diverse backgrounds are welcomed and people are at the heart of medical progress.

• Lead complex projects and manage a larger book of business, overseeing end-to-end development per business processes.
• Craft project milestones and schedules, monitor budgets, and lead production meetings to ensure quality delivery.
• Manage vendor relationships, identify risks, and support training of assistant project managers.

Inizio Evoke is a healthcare communications agency focused on making health more human. They foster a collaborative culture where everyone is all in to do their best work.

• Lead the in-house Clinical Research Associate and Clinical Budget Analyst teams overseeing study start-up activities including regulatory documentation, site budgets, and vendor management.
• Establish and apply start-up best practices, representing Clinical Operations on cross-functional teams and providing strategic leadership for Penumbra-sponsored clinical studies.
• Recruit, hire, and directly supervise team members, allocating resources and managing project timelines to meet departmental goals.

Penumbra is a global healthcare company focused on innovative therapies. It designs, develops, and markets novel products and fosters a collaborative teamwork environment.

• Leads the planning, execution, and delivery of complex global clinical studies, managing timelines, budgets, and quality.
• Oversees CROs and external vendors, ensuring alignment with study timelines, budgets, and contractual obligations.
• Drives cross-functional collaboration and communicates study progress, risks, and decisions to stakeholders.

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company cultivates an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.

• Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
• Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
• Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.

Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.

• Manage and execute a portfolio of internal and external collaborative research studies for Intuitive Surgical's Digital products and services, with responsibility for project development, budgeting, and stakeholder management.
• Oversee study documentation, compliance with regulatory requirements (GCP, ISO-14155, MEDDEV, MDR), and ensure audit readiness for all research projects.
• Build and nurture relationships with external research partners, including surgeons, hospital leaders, and healthcare technology partners, to advance evidence-generation goals.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, best known for the da Vinci surgical system. The company has been operating for nearly 30 years and fosters a culture of innovation and collaboration among engineers, clinicians, and innovators.

• Execute global clinical trials from inception through closure, supporting study-level oversight and cross-functional collaboration.
• Manage external vendors, including RFP/initiation, scope of work, deliverable oversight, and risk management.
• Drive recruitment management, study materials development, and system management for CTMS, eTMF, EDC, IRT, and ePRO.

AbbVie discovers and delivers innovative medicines and solutions across key therapeutic areas like immunology, oncology, and neuroscience. As a global biopharmaceutical company, it operates with integrity, drives innovation, and fosters a collaborative culture to transform lives.