Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Oversee and manage regional operational activities of global pivotal trials.
Develop and oversee procedures for troubleshooting and problem solving.
Maintain effective communication with vendors and internal departments.
Prilenia is a private biopharmaceutical company focused on developing transformative medicines for neurodegenerative diseases. With a highly committed and talented global team, they are developing pridopidine, an investigational neuroprotective therapy for ALS and Huntington’s disease.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Lead the planning/execution of clinical studies, aligning with regulatory/business objectives.
Manage relationships with CROs, vendors, and external partners for timely/cost-effective study delivery.
Project manage clinical trials, overseeing timelines, budgets, and deliverables.
Jobgether is a platform that helps connect job seekers with companies. They use AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements.
Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems.
Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required.
Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies.
Precision Medicine Group provides services related to clinical research. They are an equal opportunity employer.
Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
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.
Support and observe clinical site monitoring services inhouse.
Provide monitoring and site management activities for full-service studies.
Conduct remote data review, support data query and closure activities.
Alimentiv is a global contract research organization (CRO) providing clinical trials and research services. While the employee count is not provided, they appear to foster a collaborative environment.
Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Build and operationalize a scalable clinical trial site management model leveraging IVX Health’s clinical and operational infrastructure.
Lead execution of clinical trials across multiple sites, ensuring protocol adherence, predictable study start‑up, and high‑quality administration and documentation.
Serve as the senior accountable leader for regulatory compliance, quality, SOP governance, training, documentation integrity, and CAPA.
IVX Health is a national leader in high‑quality infusion and injection therapy, operating 150+ ambulatory centers across the U.S. They are backed by Linden Capital Partners and continue to scale rapidly—expanding services, accelerating growth, and building the leading ambulatory infusion platform in the country.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Ensure the development and implementation of action plans.
Lead regional/therapeutic area project resourcing.
Develop, mentor, manage and coach GCM Managers.
Precision for Medicine is a global precision medicine clinical research services organization. They improve the clinical research and development process for new therapeutics by integrating clinical operations excellence, laboratory expertise, and advanced data sciences.
Identify, structure, and execute funded research collaborations and clinical partnerships.
Translate scientific requirements into a site-friendly operational plan.
Ensure GDPR/HIPAA-aligned processes, DPAs, data minimization, and participant withdrawal workflow.
Cephalgo is a Strasbourg-based technology company founded in 2020, developing AI solutions for safety, compliance, and trust in human-AI interactions. Backed by over €3 million in funding, they combine expertise in voice AI, data protection, and compliance to help enterprises build responsible AI systems.
Lead strategic planning and execution of Medical Affairs initiatives aligned with corporate objectives.
Drive operational excellence through process improvement, change management, and performance tracking.
Partner with cross-functional stakeholders to ensure seamless integration of medical strategies.
Kardigan is a heart health company working to make cardiovascular disease preventable and curable. They're driven by patients and their families, deeply committed to improving lives and prioritizing patient needs, authentic, always learning, winning as a team, and enabling the impossible.
Lead and manage the day-to-day operational execution of assigned cell therapy trials.
Develop and manage study timelines, budgets, forecasts, and related operational metrics.
Partner with external vendors / CROs / service providers to ensure high quality and timely deliverables.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and are guided by their core values.
Maintains responsibility of assigned projects and ensures on-time delivery.
Provides input and guidance to the design of clinical databases.
Develops, tests, and validates programs and clinical databases.
Precision Medicine Group is committed to improving the efficiency of medical treatments. They focus on applying precision medicine, supported by data, to enhance research and development in the healthcare sector and is an equal opportunity employer.