Careers

Director, Clinical Operations

Position Summary

The Director, Clinical Operations will lead the management of ArriVent’s early phase ADC studies by providing strategic and tactical leadership, oversight and support to the clinical operations team for the assigned clinical programs and be accountable for all Clinical Operations deliverables, including timelines, budget, vendor oversight and data quality. This position will report to the Executive Director, Clinical Operations.  Ideally this role is located on the West Coast (pacific time zone).  Fluent speaking Mandarin is required as this role will work closely with our co-development partner in China on clinical trial execution.

Key Responsibilities

• To lead and manage cross-functional Study Team for ArriVent’s ADC programs
• Oversee the development of trial(s) timelines, budget and priorities;
• Ensure operational activities and tactical execution are linked to Program strategy and goals;
• Proactively identify, monitor, and resolve project and program risks. Collaborate with cross-functional teams and senior management to resolve complex issues promptly and effectively;
• Provide a balanced appraisal of the project and program status, including risk, cost, and value to stakeholders and senior management. Evaluate, highlight, and escalate unresolved issues, potential barriers to program progression and resource constraints;
• Assists in the cross-functional review, development and/or writing of clinical trial documents, study plans and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Diaries, Clinical Study Report and other regulatory documents;
• Establish the clinical study key performance indicators and study metrics
• Ensure robust Sponsor oversight of Service Providers and compliance with FDA regulations, GCP, ICH, and Company SOPs for all clinical operations activities;
• Collaboratively work with other Functional Areas, as well as cross-functional teams to ensure timely delivery of project deliverables with consistent high performance and quality of work;
• Lead the development and optimization of processes for Clinical Operations. Proactively assess and evaluate the need for new/updated processes and manage implementation of process improvement initiatives;
• Participate in defining vendor requirements, project scope, selection and review process. Lead vendor selection and manage change order processes as needed with efficient budget awareness;
• Strong vendor management accountability for Service Providers performance. Serve as key contributor on Sponsor/Service provider operational committees;
• Ensure management of clinical study budgets and specifications to achieve project/study goals within scope.
• Ensure tracking, financial and resourcing tools are effectively utilized. Support identification and resolution of budget and resourcing issues;

Education & Experience

• Bachelor’s degree in a scientific discipline or equivalent preferred
• (Director 15+ years) of progressive Clinical Operations experience at a biotech, pharmaceutical company or clinical CRO; 5+ years leading teams
• Phase 1-2 clinical trial experience required
• Oncology experience running pivotal, multi-regional/global clinical trials
• ADC clinical trial management experience
• Must speak fluent Mandarin and translate for team members
• Experience/knowledge in managing clinical studies in China is required
• Experience with working with China pharma in trial execution is required
• Experience managing clinical trials with a co-development partners
• Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out)
• Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required
• Possess excellent communication skills.  Candidates for this position are expected to be highly accountable and have strong interpersonal, communication and organization skills, allowing them to set and achieve objectives in the execution of the clinical programs of ArriVent.
• Ability to successfully lead a cross-functional study team
• Participated effectively in a cross-functional drug development team
• Knowledge of concepts and practices for clinical trial conduct
• Must be well versed in FDA regulations and GCP
• Previous experience with all phases of drug development
• Experience in IND/CTA filing is a plus
• Previous experience with the development of policies and SOPs
• Thorough knowledge of GCP/ICH guidelines including an understanding of regulatory requirements
• Thorough knowledge of study management & monitoring procedures