Careers

Senior Director, Clinical Data Management

Company Overview

ArriVent is a clinical-stage biopharmaceutical company with employees across the US and sites in Gaithersburg MD and Burlingame CA. We are dedicated to the identification, development and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors.

Position Summary

The Senior Director of Clinical Data Management (CDM) will be responsible for leading and managing all CDM activities to support various clinical trials in ArriVent. The ideal candidate will bring a strong background in data strategy, vendor oversight, team leadership, and hands-on experience in biotechnology or pharmaceutical environments. This position reports to the SVP of Biometrics, and is primarily remote, however, will require working closely with a cross-functional team largely based in the San Francisco Bay area. Some travel to the Burlingame, CA office may be required.

Essential Responsibilities

• Build and scale the CDM function
• Define the overall strategy for the CDM function and establish an efficient operational model
• Develop, implement and maintain Standard Operating Procedures, Working Instructions and standard templates for CDM
• Provide direction and leadership in CRO and vendor selection and management
• Manage a team of data managers for multiple molecules
• Oversee CRO’s activities to ensure the quality of deliverables and that timelines are met
• Ensure that the CDM related documentation required to support regulatory submissions and inspections are maintained to the standard required
• Participate in the generation and approval of budgets and timelines
• Collaborate closely with clinical operation, clinical science, biostatistics, statistical programming, drug safety, and regulatory to ensure operational excellence
• Lead and oversee all data management activities for multiple clinical trials, including but not limited to design and completion guidelines for eCRF, design and testing of EDC systems, development of edit checks, development of data management plan, development of data transfer agreement, SAE reconciliation, database freeze and lock activities

Required/Preferred Education, Skills, and Qualifications

• BA/BS or higher education
• 15+ years of experience in CDM in biotechnology or pharmaceutical industry
• Oncology experience in solid tumor is required
• Ability to make sound data management decisions independently to meet business needs
• Hands-on experience with mainstream EDC systems (e.g. Medidata RAVE, Inform, etc)
• Solid understanding of CDASHNDA and CDISC standard
• Extensive experience managing CROs & external vendors
• Experience of leading and managing a group of data managers
• Experience with pivotal clinical trials conducted globally in successful NDA/BLA submission is preferred
• Thorough knowledge of clinical data management and its role in the drug development process
• Solid understanding of ICH/GCP guidelines as they relate to clinical data management
• Ability to prioritize and handle multiple tasks simultaneously
• Excellent communication/interaction skills and ability to work with a global multicultural team