Head of Clinical Operations

Head of Clinical Operations

Remote, USA

We seek an experienced Head of Clinical Operations to spearhead the planning and execution of Absci’s clinical development programs. In this pivotal leadership role, you will combine strategic vision with hands-on operational excellence to guide our AI-designed antibody therapeutics from preclinical stages into and through clinical trials. In a largely outsourced model, you will lead all clinical trial planning and execution across a range of therapeutic areas (such as immunology and dermatology), ensuring programs are designed optimally and run efficiently to meet regulatory standards and company objectives. The ideal candidate is a senior-level clinical operations professional with a proven track record (10+ years) in biotech/pharma, capable of building and inspiring a high-performance team while collaborating cross-functionally in a fast-paced, mission-driven environment.

Key Responsibilities

• Operational Leadership: Provide end-to-end leadership of Absci’s clinical operations, from first-in-human studies through later-phase trials, aligning trial execution with corporate objectives and Absci’s scientific strategy. Develop the clinical operations roadmap and ensure each program has a clear plan for execution, risk mitigation, and success metrics.
• Clinical Trial Execution: Oversee the planning, initiation, and delivery of clinical trials across multiple therapeutic areas. This includes protocol development, site selection, patient recruitment strategies, on-site monitoring, data collection, and study close-out, ensuring trials are completed on time and within budget.
• Vendor & CRO Management: Lead vendor selection, manage relationships with Contract Research Organizations (CROs), clinical sites, and other external vendors. Ensure clear accountability, quality deliverables, and contract adherence from all partners. Hold CROs and vendors to high-performance standards, addressing any timeline or quality issues promptly to keep programs on track.
• Cross-Functional Collaboration: Serve as a key liaison between Clinical Operations and other departments, including Translational Research, CMC, Regulatory Affairs, Quality, and Program Management. Ensure operational strategies support clinical and regulatory goals through effective cross-functional planning. Partner with scientific leaders to incorporate the latest developments (e.g., novel biomarkers, AI insights) into trial design and execution.
• Regulatory Compliance & Quality: Ensure all clinical activities adhere to Good Clinical Practice (GCP), ICH guidelines, and applicable FDA/EMA regulations. Oversee the development and maintenance of Standard Operating Procedures (SOPs) for clinical operations and ensure trials meet the highest data integrity standards, patient safety, and ethical conduct. Maintain inspection readiness and serve as a point of contact during regulatory audits or inspections.
• Risk Management: Proactively identify potential risks and operational challenges in study conduct (such as enrollment shortfalls or data discrepancies). Develop and implement contingency and mitigation plans to address these risks, ensuring minimal disruption to study timelines and objectives.
• Process Improvement: Continuously assess and optimize clinical operations processes, tools, and metrics to drive efficiency and scalability across Absci’s portfolio. Implement best practices and innovative solutions (including digital trial tools or AI-driven analytics) to streamline workflows, improve study quality, and accelerate timelines.
• Budget & Resource Management: Oversee clinical operations, budgeting, and resource allocation for all studies. Manage the creation and monitoring of trial budgets, including forecasting, accruals, and variance analysis. Ensure optimal resource use to meet trial needs and collaborate with Finance and Procurement on vendor contracts and expense tracking.
• Stakeholder Engagement: Represent Absci’s Clinical Operations in interactions with external stakeholders. Cultivate strong relationships with clinical trial investigators, site staff, partner organizations, and key opinion leaders. Act as Absci’s clinical operations representative in joint development collaborations or partner-sponsored studies, aligning external teams with Absci’s standards and timelines.
• Clinical Data and Reporting: Oversee the collection of high-quality clinical data and ensure timely data review and cleaning. Support analysis and interpretation of clinical trial results and preparation of clinical study reports. Communicate study progress and findings to internal stakeholders and contribute to regulatory submissions (e.g., INDs, trial results in briefing documents) by providing operational insights and data.
• Patient Recruitment & Retention: Drive patient-centric recruitment and retention strategies to meet enrollment targets. Leverage innovative approaches (digital recruitment tools, patient advocacy partnerships, etc.) and ensure trial protocols are designed with patient convenience in mind . Monitor recruitment trends and adapt strategies as needed to maintain momentum in trial enrollment.

Qualifications

• Education: Advanced degree in life sciences or related field (Ph.D., MD, PharmD, MSc or equivalent) preferred. A solid scientific background is essential to engage credibly with clinical and scientific stakeholders.
• Experience: Minimum 10+ years of progressive experience in clinical operations within the biotechnology or pharmaceutical industry, including at least 5 years in a leadership role overseeing clinical trial teams. Experience managing global clinical trials across Phase 1–3 is required; a track record with early-stage (first-in-human and/or proof-of-concept) studies is highly valuable.
• Therapeutic Area Expertise: Experience in immunology, inflammation, or oncology drug development is a plus, as Absci’s pipeline includes antibody programs in these domains. Experience with biologics is a plus. 
• Regulatory & Technical Knowledge: Deep knowledge of GCP, ICH guidelines, and FDA/EMA regulations governing clinical trials . Familiarity with IND/CTA submissions and the clinical contributions to NDA/BLA filings is desired. Demonstrated ability to navigate global regulatory environments and adapt to changing requirements.
• Vendor Management: Proven experience selecting, negotiating, and managing CROs and other clinical vendors to deliver results on time and budget. Able to drive vendor performance and hold external partners accountable to high quality standards.
• Leadership & Team Management: Excellent leadership skills with a history of leading high-performing teams in a matrixed organization, including consultants and vendor staff. Able to delegate effectively, and cultivate an environment of collaboration, accountability, and continuous improvement.
• Project Management: Excellent project management and organizational skills. Capable of overseeing multiple simultaneous trials and priorities, managing complexity while maintaining attention to detail. Skilled in timeline and budget management, with the foresight to plan resources for future studies.
• Communication: Outstanding communication and interpersonal skills. Comfortable presenting to executive leadership, scientific advisory boards, and external partners. Able to translate complex clinical operational issues into clear updates and actionable plans for diverse audiences.
• Passion for Innovation: A genuine interest in cutting-edge drug development technologies. Enthusiasm for Absci’s mission of AI-driven antibody discovery and a desire to integrate novel tools and approaches to improve clinical trial outcomes.
• Work Model & Travel: This position can be held remotely in the USA, though proximity to Absci’s headquarters in Vancouver, WA, is preferred. The role will require periodic domestic and international travel to Absci sites, clinical trial locations, partner meetings, and scientific conferences. Candidates should be able to travel approximately 20-30% of the time (e.g., several days per month) to support on-site trial oversight and team engagement.

The salary range for this position is $230,000- $290,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits and ability to participate in our employee stock purchase plan.

Absci offers highly competitive salaries and benefits, including medical, dental, and vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, an employee assistance program, voluntary life and disability insurance, annual bonus potential, and a 401(k) with a generous company match. Legal authorization to work in the United States is required.