Careers

Associate Director / Director, Clinical Operations

Position Summary

Provide strategic oversight and tactical support to the clinical operations team for implementing the assigned ArriVent’s clinical programs and be accountable for all Clinical Operations deliverables associated with the programs including timelines, budget, vendor oversight and data quality in collaboration with Clinical Research Organizations, vendors, and consultants.

This role may function as a Study Lead depending on the size, complexity, and phase of the clinical program. For larger, complex studies, responsibilities may align at the Director level, while for smaller programs this role will serve as the Study lead with hands-on operational oversight. This position will have regular collaboration with a cross‑functional team based in the San Francisco Bay Area. Periodic travel to the Burlingame, CA office is required.

Key Responsibilities

• Manage and oversee operations for at least one asset or clinical study
• Serve as Study lead or operational lead based on the phase, size and complexity of the trials.
• Manage, support, train, and mentor Clinical staff members to the highest quality of output
• Contribute to and review the Clinical sections of Regulatory Applications, INDs, Clinical Study Reports, IND Annual Reports, Investigator Brochure, Protocols, Informed Consents, as well as review study management project plans and manuals. (e.g., monitoring plans, data management plans, study reference manuals, Pharmacy Manuals and Laboratory Manuals)
• Support packaging, labeling and distribution of Investigational Product (IP)
• Support managing relevant CROs and vendors as well as the clinical program budgets
• Establish and track key performance indicators
• Responsible for the forecasting and management of all clinical trial related costs
• Lead process improvement initiatives
• May support in creation of operational plans, WI, and SOPs

Qualifications Skills and Experiences

• 10 years’ experience (with bachelors) in clinical operations project management/ leadership positions
• Strong communications skills including the ability to engage with diverse internal and external collaborators as well as the ability to manage through conflicts
• Strategic skills including a high level of creativity, innovation, and problem solving
• Strong commitment to quality and accuracy as a self-starter and team contributor
• Thorough understanding of country level regulations, ICH, and GCP guidelines
• Thorough understanding of cross-functional clinical deliverables including data management, biostatistics, medical writing, drug safety, CMC, and regulatory affairs
• Preferred global program level experience across the product life cycle
• Required 4-5 years of sponsor side experience directly working for a biotech/pharma company.
• Recent Oncology experience with hands‑on responsibility for study execution and vendor oversight required.

Education

• Bachelor of Science is preferable in medical biological science, business, project management or finance; however an advanced degree is preferred