Predicta Biosciences is a precision oncology company that integrates cutting-edge multiomics and liquid biopsies to create innovative diagnostic and therapeutic products. By eliminating the need for invasive bone-marrow biopsies and using small blood-based samples, Predicta enhances immunotherapy treatment decision-making. Additionally, Predicta has developed an in-house therapeutic pipeline focused on novel immunotherapy targets in pre-clinical discovery and development.

Director, Clinical Regulatory Compliance

Position Summary

The Director of Clinical Regulatory Compliance will lead regulatory and quality compliance efforts across clinical laboratory and oncology diagnostic operations. This role is critical in making sure that Predicta’s clinical and research activities consistently meet the highest regulatory standards. The Director will also serve as a key partner to support external collaborations with academic and biopharmaceutical organizations, respond to diligence and compliance-related inquiries, and ensure the organization maintains a strong, audit-ready regulatory and quality posture.

Key Responsibilities

Regulatory Compliance

• Ensure ongoing compliance with local, state, federal and global regulations.
• Oversee clinical readiness and collaborate with Clinical Laboratory leadership to maintain impeccable compliance and meet high-complexity standards.
• Align scientific rigor with quality systems and regulatory needs.
• Anchor Clinical Lab operations to US and international standards and robust LIMS practices; align output with the needs of R&D, clinical validation, and Commercial.

Quality Systems

• In-depth understanding of Quality Management System (QMS) standards and frameworks and strong knowledge of regulatory and compliance requirements, including: FDA 21 CFR Part 820, GCP, EU MDR and other regional regulations.
• Comprehensive understanding of QMS architecture: process mapping, procedures, work instructions, records, and their interdependencies.
• Knowledge of risk management methodologies and integration into QMS processes.
• Familiarity with global quality and compliance governance models, including central vs. local responsibilities and harmonization across multiple sites/regions.
• Thorough knowledge of CAPA and nonconformance management, including root cause analysis and effectiveness verification.
• Understanding of continuous improvement methodologies and tools.
• Familiarity with electronic quality tools: eQMS, Document Management Systems (DMS), Learning Management Systems (LMS).
• Awareness of cross-cultural considerations in a global environment (communication styles, regulatory expectations, operational practices).

Data Governance and Electronic Systems

• Help ensure that computer systems, including diagnostics tools for electronic components, comply with 21 CFR Part 11 requirements for electronic records.
• Ensuring staff possess the required qualifications, training, and education, particularly for high-complexity tests.
• Data Management: Robust, secure systems for managing patient data, audit trails, and reporting.
• Embed HIPAA/GDPR-aligned data governance and healthcare interoperability (e.g., HL7/FHIR) into product and clinical reporting; champion cloud/HPC and ML where they add measurable value.
• Ensure preparedness for SOC2 Type 1 and Type 2 requirements through engaging leadership, training employees, and organizing evidence such as access logs and policies for auditors.

Inspection Readiness and Audits

• Lead internal audits and external inspections.
• Champion proactive prioritization of inspection readiness, focusing on GCP process excellence.
• Embed real-time inspection readiness strategies into daily operations, managing and guiding team on inspection readiness planning, developing and maintaining readiness plans and tools.
• Maintain documentation, including plans, timelines, and progress reports.
• Support academic and biopharma RFIs, RFPs, and due diligence questionnaires, particularly those related to regulatory compliance, quality systems, and data governance.
• Partner with Business Development, Legal, and Clinical teams to develop accurate, compelling, and compliant responses.

Clinical Development & Product Support

• Ensure compliance in clinical studies and biomarker development programs supporting oncology trials.
• Support high-quality clinical deliverables by guiding adherence to compliant operational processes and documentation.
• Provide regulatory guidance across assay development, validation, and commercialization.
• Contribute to regulatory strategy and submissions where applicable (e.g., 510(k), PMA, EUA, or LDT frameworks).

Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Clinical Laboratory Science, or related field; advanced degree preferred.
• 6+ years of experience in regulatory compliance, quality, or clinical laboratory operations within diagnostics, pharmaceutical or biotechnology fields; experience in oncology diagnostics, including NGS or liquid biopsy platforms preferred.
• Significant experience leading cross-functional quality initiatives and compliance programs in regulated industries (medical devices, diagnostics, healthcare).
• Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs.
• Track record of establishing validated compliant computational pipelines and ensuring data integrity/security in clinical or near-clinical contexts.
• Experience supporting biopharma partnerships, including RFIs/RFPs, diligence, or alliance management.

Skills & Leadership

• Proven leadership of clinical/regulated environments (CLIA/CAP/COLA; ISO 13485; 21 CFR Part 11) and fluency in translating scientific evidence into submission-ready validation packages; eligibility to complement high-complexity CLIA laboratory directorship is a strong plus.
• Exceptional writing and communication skills—able to translate technical/regulatory content for external stakeholders.
• Strong project management skills with the ability to manage multiple deadlines.
• Detail-oriented with strong judgment and risk awareness.

Work Location

This role may be remote or hybrid. Preference will be given to applicants from New England.

Why Join Predicta Biosciences?

This is a unique opportunity to be part of a mission-driven team advancing precision diagnostics for hematologic cancers. You’ll play a key role in shaping the quality and performance of our clinical testing efforts and contribute directly to patient-impactful innovations.

The annual salary range for this position is $140,000 - $200,000 plus a 10% bonus opportunity. Predicta considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role. Additional rewards include equity, flexible time off, 401k Plan, medical, dental and vision plans that are 90% paid by Predicta and a partially company funded HSA.