Vice President – Clinical Operations

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $295k - $355k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Absci

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• 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

• 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

• 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