Vice President, Clinical Operations

Absci

Standort: United States - Remote, United States (Remote)

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 http://www.absci.com or follow us on LinkedIn (@absci https://www.globenewswire.com/Tracker?data=QKz5HZjFLFcFlte0YrrQC2_RZ9jEfBFXR4U86Ihyw5yW5l0TJ95wXGFPNkalvX5xK_1tEI7VNfv2YrNozFsC63NWGGcJFFgkAi2YmFiJdyU=), X (@Abscibio https://www.globenewswire.com/Tracker?data=4f2_M87IaqlZJFPpkOQk1a253uTPOorDDdYHnQXguGq6ueEuvsZsV2iqFOgeQlUQ6K7ilz9v9z06zj1J7J095A==), and YouTube https://www.globenewswire.com/Tracker?data=pFUhTvaKrb8dfcipGtnwTLQqi0USS1LieKqGM4t6Vddl7ktIUkXqFv1wY4ZGCfxiynAyNI9n4LdC1YM1TwQcyE1K6LqS719bn4NSniK2Ab0=. 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 leaders

Vice President, Clinical Operations

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