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Director, Clinical Operations

15+ years
Not Disclosed
10 June 10, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Director, Clinical Operations – ArriVent | West Coast (Pacific Time Zone Preferred)

Job Summary

ArriVent, a leading clinical-stage biopharmaceutical company, is hiring a Director, Clinical Operations to oversee early-phase Antibody-Drug Conjugate (ADC) oncology trials. This pivotal leadership role requires Mandarin fluency due to collaboration with co-development partners in China. The ideal candidate will drive trial management, vendor oversight, cross-functional coordination, and adherence to regulatory standards across global clinical studies.

Salary Range: Not specified


Key Responsibilities

  • Lead cross-functional Study Teams for ArriVent’s ADC clinical programs.

  • Oversee clinical trial timelines, budgets, and priorities aligned with program strategy.

  • Identify, monitor, and resolve project risks in collaboration with stakeholders.

  • Prepare and review trial documents: Protocols, CRFs, ICFs, Clinical Study Reports, and regulatory submissions.

  • Establish and monitor clinical study KPIs and performance metrics.

  • Ensure compliance with FDA, GCP, ICH guidelines, and company SOPs across all operations.

  • Lead process optimization for Clinical Operations to improve efficiency and quality.

  • Manage vendor selection, oversight, and contract negotiations, including change orders.

  • Maintain clinical trial budgets, track resources, and resolve financial issues proactively.

  • Support communication between global teams, particularly with China-based partners.


Required Skills & Qualifications

  • Bachelor’s degree in a scientific discipline (preferred).

  • 15+ years of progressive Clinical Operations experience in biotech, pharma, or CRO settings.

  • 5+ years in leadership roles managing clinical teams.

  • Proven expertise in Phase 1-2 oncology trials; ADC trial experience required.

  • Fluent Mandarin speaking and translation skills required.

  • Experience managing clinical trials and partnerships in China.

  • Knowledge of FDA regulations, ICH-GCP, trial monitoring, data management, and SOP development.

  • Experience with IND/CTA filings is a plus.

  • Strong vendor management and CRO oversight capabilities.

  • Excellent communication, leadership, and cross-functional team management skills.


Perks & Benefits

  • Competitive compensation package (salary not disclosed)

  • Leadership role in a high-impact oncology drug development program

  • Opportunity to work on global, cutting-edge ADC therapies

  • Collaborative and innovative biotech environment

  • Professional growth and development opportunities


Company Description

ArriVent is a pioneering biopharmaceutical company committed to developing innovative oncology treatments to address critical unmet needs. Located in the San Francisco Bay Area, ArriVent fosters a fast-paced and collaborative work culture focused on scientific excellence and breakthrough drug discovery.


Work Mode

Hybrid / On-site Preferred (West Coast, Pacific Time Zone)


Call to Action

Are you ready to lead global ADC oncology trials and make a real impact? Apply now to join ArriVent as Director, Clinical Operations and drive the future of cancer research.

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