Manager of Clinical and Regulatory Affairs at Pangea Laboratory, LLC

Tustin, California, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Sep, 26

Salary

160000.0

Posted On

06 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evidence Generation, Clinical Utility Studies, Project Management, CRO Management, GCP, IVDR, CE-IVD, Data Analysis, Scientific Writing, Regulatory Coordination, Clinical Operations, Stakeholder Management

Industry

Medical and Diagnostic Laboratories

Description

Job Summary: 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. Key Responsibilities: Clinical Affairs (Primary Focus): * 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 Education and Experience: * 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 Preferred: * Experience in molecular diagnostics, oncology, urology, or laboratory-developed tests (LDTs) * Experience supporting clinical utility or observational studies * Exposure to regulatory processes for IVD or CE-IVD / IVDR (direct ownership not required) * Experience supporting publications, abstracts, or scientific presentations * Experience in a small or early-stage company environment About us: Pangea Laboratory is a California-based diagnostics company founded in 2014. We focus on the precise, early detection of emerging diseases. Our mission is to have a positive impact on human life, by providing biomedical communities with reliable and high-quality testing services, delivering the data they need to diagnose and treat diseases in an effective and timely manner. Named a Top Workplace by the OC Register, Pangea Laboratory continues to be a place where employees feel engaged, connected, and energized about their work. If you are passionate about helping people in advancing science and working with awesome teams in a fast-growing company, we want to speak with you! How We Work: Our Values: * Focus – Relentless Prioritization. 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. Although we are focused, we realize adaptability to unplanned environmental changes is required. * Reliability – We are accountable to what we say we will do. We are reliable to our customers and to our teammates. Decision Drivers: What we always consider when making decisions * Culture – How will it impact teammates and our work environment. Team first. * Customer – How will it impact Physicians, Patients, Payors, and Partners * Compliance – How will it impact quality, regulatory, and legal requirements CORE Operating Behaviors: * 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. Compensation: The estimated base compensation range for this position is $130,000-$160,000 annually at the time of posting. Actual compensation details will be provided in writing at the time of offer, if applicable, and it is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. Equal Employment Opportunity Employer: Pangea Laboratory welcomes candidates of all backgrounds. These include sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender, gender identity, gender expression, physical & mental disability, medical condition, genetic information, military and veteran status, or any other protected status as defined by federal, state, or local law. Location: Onsite – Pangea HQ – 14762 Bentley Cir. Tustin, CA 92780

Responsibilities

Lead the execution of clinical evidence generation and utility studies for the Bladder CARE diagnostic to support physician adoption and payer engagement. Coordinate with external partners and provide secondary support for CE-IVD/IVDR regulatory documentation and tracking.