Head of Clinical Operations
Head of Clinical Operations
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$ 230000 - 290000
1 Vacancy
Job Description
Absci is a datafirst AI drug creation company designing differentiated therapeutics using generative AI. Our Integrated Drug Creation platform powers cuttingedge de novo AI models and AI lead optimization models aimed at designing better biologics against difficulttodrug targets.
Absci is a global company with a stateoftheart lab and headquarters in Vancouver WA AI Research Lab in New York City AI Computational Center in Serbia and Drug Creation innovation center in Switzerland. of Clinical Operations
Remote USA
We seek an experienced Head of Clinical Operations to spearhead the planning and execution of Abscis clinical development programs. In this pivotal leadership role you will combine strategic vision with handson operational excellence to guide our AIdesigned 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 seniorlevel clinical operations professional with a proven track record (10 years) in biotech/pharma capable of building and inspiring a highperformance team while collaborating crossfunctionally in a fastpaced missiondriven environment.
Key Responsibilities
- Operational Leadership: Provide endtoend leadership of Abscis clinical operations from firstinhuman studies through laterphase trials aligning trial execution with corporate objectives and Abscis 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 onsite monitoring data collection and study closeout 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 highperformance standards addressing any timeline or quality issues promptly to keep programs on track.
- CrossFunctional 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 crossfunctional 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 Abscis portfolio. Implement best practices and innovative solutions (including digital trial tools or AIdriven 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 Abscis Clinical Operations in interactions with external stakeholders. Cultivate strong relationships with clinical trial investigators site staff partner organizations and key opinion leaders. Act as Abscis clinical operations representative in joint development collaborations or partnersponsored studies aligning external teams with Abscis standards and timelines.
- Clinical Data and Reporting: Oversee the collection of highquality 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 patientcentric 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 13 is required; a track record with earlystage (firstinhuman and/or proofofconcept) studies is highly valuable.
- Therapeutic Area Expertise: Experience in immunology inflammation or oncology drug development is a plus as Abscis 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 highperforming 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 cuttingedge drug development technologies. Enthusiasm for Abscis mission of AIdriven 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 Abscis 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 2030% of the time (e.g. several days per month) to support onsite trial oversight and team engagement.
The salary range for this position is $230000 $290000/year. Competitive equity package applies. Pay offered may vary depending on jobrelated 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.
We seek candidates who will dive into our creative company culture thats collaborative multidisciplinary and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers creative scientists and datadevoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you we invite you to join us in our quest to redefine possible.
Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color gender age religion national origin ancestry disability veteran status genetic information sexual orientation or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. Absci offers a dogfriendly work environment bring your pup along for the ride.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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