Absci

Clinical Operations

• Provide end-to-end Sponsor operational leadership and accountability for the clinical program across Phase 1/2 studies and the registrational Phase 3 program
• Translate clinical development strategy into an integrated global operational strategy covering sequencing, timelines, country and site strategy, enrollment, resources, vendors, budgets, systems, and dependencies
• Serve as senior Study Management representative on the cross-functional program team
• Develop and maintain integrated program plans and critical paths across studies
• Provide operational input into protocol development and study design
• Lead global feasibility, trial optimization, enrollment modeling, and country/site placement strategy
• Lead global site start-up and activation strategy and manage critical paths
• Establish start-up metrics, dashboards, predictive indicators, and a single source of truth for program execution
• Provide hands-on Sponsor oversight of Phase 1 and Phase 2 studies
• Lead operational readiness for the registrational Phase 3 program
• Identify, assess, escalate, and mitigate operational risks
• Establish CRO governance and hold CROs and vendors accountable for delivery, quality, timelines, enrollment, start-up, issue resolution, and budgets
• Lead CRO/vendor selection, scope development, contracting strategy, change-order management, and performance management
• Build relationships with investigators and sites and incorporate site insights into operational strategy
• Apply AI, advanced analytics, automation, digital technologies, and AI-enabled workflows to improve trial planning, execution, forecasting, oversight, and decision-making
• Partner with Clinical Development, Regulatory, Biometrics/Data Management, Safety, Quality, Technical Operations, Development Services, technology, and data science teams
• Provide decision-oriented program updates to senior leadership
• Ensure inspection readiness, GCP compliance, Sponsor oversight, and documentation of decisions, risks, escalations, and governance
• Mentor Study Management team members and build program-management capabilities within Global Clinical Operations

Vice President – Clinical Operations

Director

• Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies, programs, and functional areas
• Develop, implement, and maintain a risk-based inspection readiness framework
• Assess clinical study and operational-process readiness, including documentation, Sponsor oversight, issue management, data integrity, and regulatory adherence
• Identify compliance, process, documentation, and oversight gaps and drive remediation and preventive actions
• Oversee clinical trial registration and results-reporting requirements, including ClinicalTrials.gov
• Track reporting requirements, accountabilities, timelines, supporting documentation, and compliance evidence
• Assess clinical development training requirements and training matrices
• Review and improve SOPs, work instructions, plans, templates, and controlled documents
• Support development, implementation, training, and adoption of new or revised processes
• Partner with Data Management/Biometrics and cross-functional teams on operational quality, data integrity, issue resolution, and database-lock readiness
• Support inspection-ready Trial Master Files and essential records
• Evaluate CRO and vendor oversight practices and documentation
• Establish inspection-readiness metrics, dashboards, risk indicators, and management routines
• Lead or coordinate mock inspections, gap assessments, and targeted deep dives
• Support regulatory inspections and Sponsor audits, including planning, document readiness, interview preparation, response coordination, and remediation
• Partner with Quality to align Clinical Operations execution with the Quality Management System
• Monitor evolving ICH-GCP expectations, regulations, inspection trends, and industry best practices
• Promote quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness
• Provide senior-level coaching and guidance on GCP compliance, inspection readiness, documentation, and operational excellence
• Support strategic initiatives across Global Clinical Operations and the broader development organization
• Travel domestically and internationally up to 20–30% as required

Senior Director, Inspection Readiness

Human Resources

• Manage onboarding and offboarding end to end, including data entry, systems setup, coordination with IT and facilities, and exit logistics
• Maintain and audit accurate employee data in Rippling
• Process promotions, transfers, and terminations in Rippling
• Respond to employee questions about policies, processes, benefits, and general HR matters
• Support HR and benefits compliance tasks, including I-9s, required postings, 5500s, EEO reports, and recordkeeping
• Administer leave of absence programs from request through return to work
• Support open enrollment, employee communications, election troubleshooting, and post-transmission file audits
• Serve as the primary contact for benefits questions
• Manage benefits enrollment and termination in carrier portals and reconcile records with Rippling
• Partner with brokers and carriers on escalations and plan administration issues
• Open and post roles in Ashby
• Coordinate interview scheduling and candidate communication
• Maintain applicant tracking records and recruiting status updates
• Support offer letters and pre-employment and new-hire documentation
• Initiate background checks and follow up on discrepancies

HR Generalist

Manager

• Support the buildout and implementation of a robust Quality Management System
• Own and continuously improve the QMS, ensuring it is fit-for-purpose and inspection-ready
• Define and maintain quality standards, SOPs, and process documentation across GCP, GMP, and GLP environments
• Lead and manage internal and external audits
• Manage CRO/CMO vendor qualification and ongoing oversight
• Partner with Regulatory to support submission requirements and agency inspections
• Oversee CAPA management, deviation handling, and change control processes
• Champion quality certifications and ensure compliance with relevant ISO standards
• Build relationships across R&D, Clinical, Manufacturing, IT, and Legal
• Partner cross-functionally to build quality foundations early in workflows
• Opportunity to build a team as Absci scales

Senior Manager, Quality

Compliance

• Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms
• Develop and execute regulatory strategy across the product development and commercial lifecycle, focusing on FDA and applicable international authorities such as EMA and ICH
• Monitor evolving regulatory and legislative landscapes, including AI/ML guidance, data privacy law, and biotech-specific frameworks, and assess business impact
• Serve as primary liaison for regulatory agency interactions, submissions, and inspections
• Lead internal investigations and audits, and manage corrective action and remediation processes
• Develop and implement a GDPR-ready data governance framework, including DPIAs, ROPAs, and data subject rights mechanisms
• Establish privacy-by-design principles across product and platform development with Engineering and Product teams
• Ensure privacy governance structures across jurisdictions where Absci operates or processes personal data
• Lead vendor and third-party data protection due diligence, including DPAs and sub-processor compliance
• Maintain incident response and breach management protocols satisfying GDPR's 72-hour notification window
• Report regulatory, compliance, privacy program status, and GDPR readiness metrics to the CLO, Board, or external stakeholders
• Collaborate with Legal, Quality, IT, and Clinical teams to embed compliance into business operations

Director, Regulatory & Compliance

Clinical Research

• Independently manage all operational aspects of assigned Phase II–III global clinical trials from startup through closeout
• Ensure adherence to protocols, regulatory requirements, and ethical standards
• Oversee CROs and vendors against study goals, regulatory standards, and timelines
• Develop and maintain study-level operational, monitoring, communication, and risk-management plans
• Review monitoring visit reports and ensure Trial Master File quality control
• Maintain study documentation and operational trackers for Sponsor oversight
• Implement patient recruitment and retention strategies with sites and CROs
• Partner with legal and finance teams on study budgets, insurance adequacy, privacy and data-protection protocols, and contracts
• Identify operational risks and implement mitigation and contingency plans
• Support clinical-data analysis, troubleshooting, interpretation, reporting, and stakeholder communication
• Monitor industry developments, regulatory changes, and clinical research methodologies
• Build relationships with cross-functional teams, CROs, vendors, and investigator sites
• Communicate with sites and stakeholders on sensitive health topics while protecting participant safety and dignity

Vice President – Clinical Operations

Senior Director, Inspection Readiness

HR Generalist

Senior Manager, Quality

Director, Regulatory & Compliance

Clinical Trial Manager