Vice President – Clinical Operations

Absci

. Provide end-to-end Sponsor operational leadership and accountability for the clinical program across Phase 1/2 studies and the registrational Phase 3 program .

Posted 9/29/2026full-timeRemote • United StatesLead💰 $295,000 - $355,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global clinical operations, particularly in leading complex late-stage clinical programs, including Phase 3 studies. Proficient in operational strategy, CRO governance, and utilizing advanced analytics and digital technologies to enhance trial execution and oversight.

Highest-signal resume keywords

Global Clinical Program LeadershipCRO Governance and ManagementAdvanced Analytics and AI-Enabled ToolsICH-GCP ComplianceCross-Functional Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsStudy ManagementOperational StrategyFeasibility AssessmentEnrollment ModelingSite Start-Up and ActivationRisk ManagementVendor SelectionContracting StrategyRegulatory Submission Readiness

Soft Skills

Executive CommunicationJudgmentProblem-SolvingDecision-MakingInfluencing Stakeholders

Tools & Technologies

Digital TechnologiesAutomation ToolsAI-Enabled WorkflowsPredictive IndicatorsDashboards

Industry Keywords

Phase 1 StudiesPhase 2 StudiesPhase 3 StudiesGCP ComplianceFDA InteractionsBiotechnology EnvironmentGlobal Regulatory Requirements

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s degree in life sciences or a related field
20+ years of progressive clinical operations and Study Management experience in a Sponsor organization
Significant leadership responsibility for global clinical programs
Proven experience leading complex global late-stage and registrational clinical programs, including Phase 3 studies, from operational strategy and feasibility through start-up, execution, database lock, and regulatory submission readiness
Experience providing end-to-end program-level operational leadership across multiple studies
Deep expertise in global feasibility, country and site strategy, enrollment modeling, site start-up and activation, monitoring strategy, patient recruitment and retention, and risk management
Deep expertise in CRO governance and outsourced clinical development
Experience with vendor selection, contracting, governance, performance management, escalation, and holding external partners accountable
Experience planning and preparing large-scale registrational programs well in advance of Phase 3 initiation
Experience using advanced analytics, automation, AI-enabled tools, or digital technologies in clinical trials
Strong knowledge of ICH-GCP and applicable global regulatory requirements
Experience supporting FDA and other major health-authority interactions and inspection-ready clinical programs
Strong cross-functional leadership and ability to influence senior stakeholders and drive decisions without relying on direct authority
Excellent executive communication, judgment, problem-solving, and decision-making skills
Legal authorization to work in the United States
Advanced degree preferred
Experience in a small or mid-size biotechnology environment strongly preferred

Benefits

Comp & perks

Equity
Annual bonus potential
Medical insurance
Dental insurance
Vision insurance
Unlimited vacation
Parental leave
Employee assistance program
Voluntary life insurance
Voluntary disability insurance
401(k) with a generous company match
Up to 20–30% domestic and international travel