Vice President, Clinical Operations

About Absci

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets.

Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio), and YouTube.

Role Summary

The VP, Clinical Ops is a senior, hands-on Study Management leader responsible for end-to-end Sponsor operational leadership of a clinical development program. This individual will provide strategic and operational oversight of ongoing Phase 1 and Phase 2 studies while leading the operational strategy, planning, feasibility, start-up, and readiness required for an upcoming global registrational Phase 3 program.

This role will serve as the accountable Study Management leader for the program, integrating execution across studies, countries, CROs, vendors, sites, and internal functions. The leader will translate the clinical development strategy into a clear and executable global operational plan; anticipate program-level risks and dependencies; establish rigorous governance and accountability; and ensure delivery of key development milestones with quality, speed, and predictability.

Given Absci’s size and growth stage, this leader must combine strategic program leadership with a willingness to remain close to execution. The successful candidate will bring substantial experience leading complex global late-stage and registrational programs and will use data, technology, AI-enabled tools, and disciplined Sponsor oversight to maximize the effectiveness of a lean internal team.

Key Responsibilities

· Provide end-to-end Sponsor operational leadership and accountability for the clinical program, spanning current Phase 1/2 studies and planning and execution of the registrational Phase 3 program.

· Translate the clinical development strategy into an integrated global operational strategy, including study sequencing, timelines, country and site strategy, enrollment assumptions, resource requirements, vendor strategy, budgets, systems, and key operational dependencies.

· Serve as the senior Study Management representative on the cross-functional program team, ensuring operational considerations, risks, options, and trade-offs are incorporated into program-level decisions.

· Develop and maintain an integrated program plan and critical path across studies, identifying interdependencies and ensuring readiness for key clinical, regulatory, and development milestones.

· Provide senior operational input into protocol development and study design to ensure protocols are operationally feasible, executable globally, and aligned with enrollment, site, patient, data-quality, and timeline objectives.

· Lead global feasibility and trial optimization, integrating epidemiology, competitive trial landscape, patient pathways, site capabilities, historical performance, recruitment potential, and operational complexity into country and site decisions.

· Own country and site placement strategy, enrollment modeling, and feasibility scenario planning for the Phase 3 program; establish realistic assumptions and contingency scenarios that support program timelines and enrollment objectives.

· Lead the global site start-up and activation strategy, including country sequencing, regulatory and ethics dependencies, site identification and qualification, contracting and budget assumptions, activation targets, and critical-path management.

· Establish start-up performance metrics and dashboards and proactively identify bottlenecks in regulatory submissions, contracts, budgets, essential documents, site activation, and other start-up activities.

· Partner with CROs and internal stakeholders to optimize site selection and activation, ensuring resources are concentrated on sites and countries most likely to deliver high-quality patients within required timelines.

· Continuously reassess feasibility and enrollment assumptions using emerging study data and external intelligence and recommend timely adjustments to country footprint, site mix, recruitment strategy, or resourcing.

· Provide hands-on Sponsor oversight of ongoing Phase 1 and Phase 2 studies, ensuring delivery against timelines, enrollment goals, budgets, quality standards, and program objectives.

· Lead comprehensive operational readiness for the registrational Phase 3 program, including country footprint, site strategy, feasibility, enrollment modeling, start-up, monitoring approach, CRO/vendor capabilities, resourcing, systems, recruitment strategy, and operational infrastructure.

· Ensure Phase 3 planning begins sufficiently early to support rapid transition from Phase 2 data and regulatory feedback into registrational execution without avoidable operational delay.

· Drive proactive identification, assessment, escalation, and mitigation of risks related to enrollment, start-up, sites, vendors, timelines, quality, data, resources, and study execution.

· Establish and lead rigorous CRO governance, including clear roles and responsibilities, decision rights, escalation pathways, performance expectations, KPIs, governance forums, and senior-level engagement.

· Hold CROs and vendors accountable for delivery, quality, timelines, enrollment, start-up, issue resolution, and budget performance while maintaining clear evidence of Sponsor oversight.

· Provide senior leadership for CRO and vendor selection, scope development, contracting strategy, change-order management, and ongoing performance management.

· Build effective relationships with key investigators and sites and ensure site-level insights are incorporated into feasibility, recruitment, retention, and operational strategy.

· Apply AI, advanced analytics, and automation to high-value operational challenges, including feasibility modeling, enrollment forecasting, site selection, site-performance analytics, recruitment optimization, risk identification, and CRO oversight.

· Partner with appropriate internal technology, data science, and functional teams to identify and implement AI-enabled workflows that improve speed, visibility, decision quality, and Sponsor oversight without compromising GCP compliance or data integrity.

· Establish a single source of truth for program execution across internal functions, CROs, and vendors, with timely visibility into enrollment, start-up, site performance, milestones, risks, issues, and budget performance.

· Develop program-level dashboards and predictive indicators that allow the team to identify emerging risks and performance trends early and take corrective action before key milestones are affected.

· Evaluate innovative technologies, digital approaches, and operating models that can improve trial delivery and enable a lean Sponsor team to effectively oversee a large global registrational program.

· Partner closely with Clinical Development, Regulatory, Biometrics/Data Management, Safety, Quality, Technical Operations, Development Services, and other functions to ensure integrated planning and execution.

· Provide concise, decision-oriented program updates to senior leadership, clearly communicating status, risks, mitigations, critical decisions, and implications for development timelines and resources.

· Ensure inspection readiness, GCP compliance, high-quality Sponsor oversight, and appropriate documentation of key decisions, risks, escalations, and governance throughout the program.

· Mentor and guide Study Management team members supporting the program and help build strong program-management capabilities within Global Clinical Operations.

· Up to 20–30% domestic and international travel, as required.

Qualifications & Preferred Skills

· Bachelor’s degree in life sciences or a related field; advanced degree preferred.

· 20+ years of progressive clinical operations and Study Management experience in a Sponsor organization, with significant leadership responsibility for global clinical programs.

· Proven track record 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.

· Demonstrated experience providing end-to-end program-level operational leadership across multiple studies and translating development strategy into integrated execution plans.

· 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, including vendor selection, contracting, governance, performance management, escalation, and holding external partners accountable.

· Demonstrated ability to plan and prepare for large-scale registrational programs well in advance of Phase 3 initiation, including scenario planning, resourcing, vendor capacity, systems, technology, and operational infrastructure.

· Experience using advanced analytics, automation, AI-enabled tools, or digital technologies to improve clinical trial planning, execution, forecasting, oversight, or decision making.

· Strong knowledge of ICH-GCP and applicable global regulatory requirements, with experience supporting FDA and other major health-authority interactions and inspection-ready clinical programs.

· Strong cross-functional leadership skills and demonstrated ability to influence senior stakeholders, drive decisions, and create accountability without relying on direct authority.

· Experience operating in a small or mid-size biotechnology environment strongly preferred; must be comfortable combining strategic leadership with hands-on operational involvement.

· Excellent executive communication, judgment, problem-solving, and decision-making skills, with the ability to communicate complex operational issues clearly and concisely.

Leadership Profile

The successful candidate will be an experienced global Study Management leader who combines strategic program leadership with deep operational execution expertise. They will bring a strong Sponsor perspective, anticipate risks before they affect critical milestones, and drive CROs, vendors, sites, and cross-functional teams toward program objectives. This individual will be equally comfortable shaping global operational strategy, leading feasibility and Phase 3 readiness, applying AI and analytics to improve decision-making, and working directly with teams to resolve complex execution challenges. The leader will operate with urgency, accountability, sound judgment, and a strong commitment to quality and operational excellence.

Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact [email protected].