Job Summary:

The Director of Clinical and Regulatory Affairs owns the clinical and regulatory strategy for Pangea’s diagnostic portfolio, including prioritization, sequencing, and execution of clinical programs and regulatory submissions. This role focuses primarily on clinical trials and submissions to enable regulatory authorization (IVDR and FDA) and market access for Bladder CARE, while also supporting emerging initiatives in NGS-based microbiome diagnostics.

This position is ideal for a highly motivated professional who can operate strategically and tactically within a lean team environment. The director will be expected to manage and execute programs efficiently with limited resources, collaborating closely with the Chief Scientific Officer and a Clinical Trial Project Manager.

Clinical Strategy & Execution

  • Define and own the clinical strategy for Bladder CARE and future diagnostic programs, including study prioritization, timelines, budgets, and evidence generation plans aligned with regulatory, commercial, and reimbursement goals.
  • Contribute to protocol and statistical analysis plan development and execution, study site selection, and coordination of clinical operations with internal and external partners (CROs, clinical sites, and investigators).
  • Ensure clinical data collection and management meet regulatory and scientific standards (GCP, ISO 14155).
  • Oversee post-market clinical follow-up and real-world evidence (RWE) programs to support market expansion.

Regulatory Affairs

  • Own the global regulatory strategy and decision-making for Pangea’s diagnostic products, including prioritization and sequencing of IVDR, FDA, and state-level submissions in alignment with business objectives.
  • Serve as the primary liaison with consultants, regulatory agencies and notified bodies, managing submissions, responses, and audits.
  • Maintain regulatory compliance across all clinical and diagnostic activities.
  • Work collaboratively with quality and laboratory teams to ensure ongoing compliance with CAP/CLIA, ISO 13485, and IVDR requirements.

 

Reimbursement & Market Access

  • Lead clinical and health economics studies to support payer coverage and reimbursement pathways.
  • Collaborate with market access and health economics consultants as well as external advisors to build evidence supporting clinical utility and cost-effectiveness.
  • Support the generation of publications and white papers that strengthen payer and physician adoption.

Other

  • Provide clinical, scientific and regulatory input to product development teams and senior leadership.
  • Support research collaborations, grant applications, and publications related to Bladder CARE and NGS microbiome initiatives.
  • Build, mentor and guide the Clinical & Regulatory Affairs teams.

 

Education:

  • Advanced degrees (PhD, PharmD, MD, or MS) in a biomedical or life science field.
  • Minimum of 5+ years (8+ preferred) of progressive experience in clinical and regulatory affairs, with increasing leadership responsibilities with in vitro diagnostics (IVD) or molecular diagnostics.
  • Proven experience with IVDR Technical Documentation, NYSDOH submissions, and FDA submissions (510(k), De Novo).
  • Track record of managing clinical trials for diagnostic products (oncology experience preferred).
  • Experience supporting market access and payer evidence generation strongly preferred.
  • Familiarity with NGS workflows and microbiome research is a plus.

 

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 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