Manager of Clinical and Regulatory Affairs

Benefits

Qualifications

• •Bachelor's or Master's degree in life sciences, biomedical sciences, public health, or related field
• •4-7 years of experience in clinical affairs, clinical research, or clinical operations within diagnostics, medical devices, biotechnology, or laboratory testing
• •Experience supporting clinical studies, including site/vendor coordination, data tracking, and study execution
• •Strong project management skills with ability to manage multiple studies and timelines simultaneously
• •Experience working with CROs, investigators, or external clinical partners
• •Familiarity with GCP and general clinical research standards
• •Strong organizational, communication, and problem-solving skills
• •When we decide the business priorities and initiatives to support those priorities, we execute with disciplined focus
• •Agility - Flexible and Proactive
• •In a start-up type of environment, "not in by job description" doesn't ever come to mind
• •Creative, resourceful problem solving
• •We embrace problems and look forward to creative problem solving
• •Clear, transparent, and effective communication
• •Willing to discuss, debate, and then execute on decision with no looking back
• •Leadership through influence and trust, not hierarchy
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Responsibilities

• •The Manager of Clinical Affairs is responsible for the execution of clinical evidence generation activities for Pangea's Bladder CARE diagnostic, with a primary focus on clinical utility studies, publication support, and evidence development to support physician adoption and payer engagement
• •This is a hands-on, execution-focused role in a lean environment
• •The position will coordinate clinical studies with internal teams and external partners (sites, investigators, CROs), manage timelines and deliverables, and support data analysis and publication activities
• •The role also provides limited regulatory support, primarily coordinating with external regulatory consultants and internal stakeholders for CE-IVD / IVDR-related activities
• •This role is not responsible for regulatory strategy or direct agency interaction
• •Support the planning and execution of clinical studies for Bladder CARE, including clinical utility and evidence generation initiatives
• •Coordinate study activities with external partners, including investigators, clinical sites, CROs, and vendors
• •Assist in development and refinement of study documents, including protocols, case report forms, and study plans
• •Track study timelines, milestones, budgets, and deliverables to ensure on-time execution
• •Monitor study progress and identify risks or delays, escalating as needed
• •Support data collection, data quality review, and coordination with biostatistics or external partners
• •Contribute to preparation of abstracts, manuscripts, and scientific presentations
• •Support development of evidence packages used for physician education, publications, and payer discussions
• •Maintain organized documentation to support study execution and audit readiness
• •Regulatory Support (Secondary Focus):
• •Support CE-IVD / IVDR-related activities by coordinating with external regulatory consultants and internal teams
• •Assist in compiling documentation and tracking deliverables required for regulatory submissions
• •Maintain regulatory documentation, trackers, and internal files
• •Coordinate cross-functional inputs (lab, quality, clinical) required for regulatory activities
• •Monitor timelines and ensure alignment with project milestones
• •Cross-Functional Collaboration:
• •Provide clinical, scientific and regulatory input to product development teams and senior leadership
• •Work closely with laboratory operations, R&D, commercial, and leadership teams
• •Coordinate with external consultants (clinical, regulatory, statistical) as needed
• •Support communication of study progress and key updates to internal stakeholders
• •Contribute to a collaborative, execution-focused environment in a growing organization
• •Reliability - We are accountable to what we say we will do
• •Customer - How will it impact Physicians, Patients, Payors, and Partners
• •Compliance - How will it impact quality, regulatory, and legal requirements
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