Source Job

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

As Clinical Trial Manager, you will lead CRAs and oversee clinical aspects of studies across multiple countries. You will ensure timeline adherence and scope, whilst ensuring quality delivery. Management and operational delivery of the clinical elements within a trial including site selection, start-up, and data cleaning activities. Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.

Precision for Medicine is a precision medicine CRO which combines novel clinical trial designs, experts and biomarker solutions.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.

The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.

This position is posted by Jobgether on behalf of a partner company.

• Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
• Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
• Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.

GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.

This position is posted by Jobgether on behalf of a partner company.

• The Medical Director serves as the project physician and provides medical and scientific expertise to project teams, ensuring data accuracy and patient safety.
• Support Business Development by participating in the RFP process, preparing medical considerations for proposals, and participating in bid defense meetings.
• Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. They integrate clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate all necessary activities required to set up and monitor a study.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.

Lead global regulatory activities for cell therapy programs as the Global Regulatory Lead. Shape regulatory strategy, lead health authority interactions, and support documentation. Collaborate with Clinical, CMC, Nonclinical, Quality, and Program Management teams.

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.

As Legal Counsel, you will shape the regulatory and compliance framework. You'll work at the intersection of law, technology, and entrepreneurship. You will support a dynamic ecosystem where progress is driven by those who dare.

Critical Ventures backs those who build—not just founders seeking exits, but visionaries who see the world as it could be and act without waiting for permission.

The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care

• Assist with daily site activities, acting as the primary point of contact for the site.
• Assist with training and mentoring research staff, upholding professional development goals.
• Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.

• Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.

Precision for Medicine combines novel clinical trial designs, operational and medical authorities, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. They are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.

• Lead complex clinical trials from initiation through completion.
• Oversee cross-functional teams and manage project scope.
• Contribute to high-impact clinical research projects.

This position is posted by Jobgether on behalf of a partner company.

• Manage a team of Clinical Specialists and independent contractors.
• Develop and deliver clinical education to sales, clinical specialists, marketing, surgeons, and OR staff.
• Collaborate with Quality, Regulatory, Marketing, and R&D to develop clinical education around new product development.

Calyxo, Inc. is a medical device company founded in 2016 to address the profound need for improved kidney stone treatment.

• Manages central laboratory and specialty vendors across clinical trials.
• Provides support for sample related matters to clinical study teams.
• Assists with vendor selection and oversight.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.

Oversee regulatory operations across our expanding national footprint. Guide state higher education approvals, partner with campus and executive leaders. Shape the regulatory framework that supports our mission to transform nursing education.

Arizona College of Nursing transforms people’s lives by preparing them for careers in nursing and improving communities through the care its graduates provide.