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.
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.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
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.
Lead and develop clinical operations teams, overseeing oncology trial execution from feasibility to closeout.
Drive process improvements and operational excellence to enhance study delivery and site performance.
Ensure compliance with regulations, manage budgets and resources, and foster stakeholder relationships.
The company is a global clinical development organization focused on advancing oncology therapies through clinical trials. It fosters a collaborative and inclusive work environment with opportunities for professional growth and continuous learning.
Lead and manage the Clinical Solution Analyst team, overseeing resourcing, performance, and career development.
Act as a senior product subject matter expert, shaping solution design and providing delivery insights to inform the product roadmap.
Partner with Sales to support feasibility assessments and with customers to ensure successful onboarding and delivery.
Evinova is a health-tech business focused on accelerating better health outcomes through digital transformation in the life sciences sector. The company fosters a collaborative, fast-paced culture with a shared purpose to transform health through data and digital innovation.
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.
Act as a strategic partner for key customers, leading governance, growth initiatives, financial performance, and cross-functional collaboration.
Lead and oversee global, multiregional, or complex regional Clinical FSP partnerships, ensuring alignment with contractual agreements and strategic priorities.
Provide executive oversight for clinical FSP delivery, ensuring quality, timelines, key performance indicators, and contractual commitments are achieved.
The employer is a global clinical research organization that partners with pharmaceutical and biotech companies to deliver clinical trials. They are a large, established company with a culture focused on innovation, collaboration, and advancing healthcare worldwide.
Independently negotiate and manage complex clinical trial agreements, site budgets, and amendments with minimal training.
Partner cross-functionally with Clinical Operations, Finance, and Legal to ensure compliant and timely study startup.
Serve as subject matter expert and escalation point for contract and budget issues across global studies.
CareDx is a leading precision medicine solutions company focused on improving outcomes for transplant patients through innovative diagnostics, services, and digital health solutions. As a leader in genomics-based transplant information, the company offers a competitive Total Rewards package and fosters a mission-driven culture where employees directly impact patient lives.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
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.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
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.
Lead operational execution of cell therapy trials from startup through close-out, managing timelines, budgets, and vendor oversight.
Ensure compliance with regulatory standards including FDA, EMA, and ICH-GCP, and contribute to protocol development and study documents.
Collaborate cross-functionally with clinical operations, data management, regulatory, and manufacturing teams to drive study success.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. They are guided by core values of collaboration and innovation, fostering a culture of ownership and clarity.
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.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.
Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.
Provide strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Oversee project administration and management of early phase clinical trials for the Pediatric Early Phase Clinical Trial Network.
Manage grants administration, budget oversight, and progress reporting for a $3M+ annual grant.
Lead and mentor a team, ensuring study development and implementation within sponsor timelines.
COG Research Foundation, LLC is a California 501(c)(3) entity that serves as a fiscal sponsor for research programs, providing legal, fiduciary, and administrative oversight. The foundation supports the Children's Oncology Group, which unites over 13,500 experts at more than 220 leading children's hospitals and cancer centers across multiple countries.