Job Description

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.

Summary of Position:

The Senior Director, Clinical Research will provide direct oversight and leadership in the execution of ArriVent’s clinical research plan. This role actively leads in the planning, implementation and daily operation of drug development projects. In this role, you will lead, and support Department/Clinical initiatives focused on enhancing the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our portfolio. This position reports to the SVP of Clinical Development. This position is based in the San Francisco Bay Area.

Key Responsibilities:

• Lead development of key clinical development deliverables including protocols, CSRs, IBs, and other clinical development deliverables in collaboration with Medical Directors and other functions.
• Lead Clinical Science function to support developing various regulatory documents, such as Dossiers, NDAs, INDs, Safety and Annual reports. This includes expertly handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
• Oversee clinical trials to assess study progress, ensure proper study conduct and adherence to the protocol. Lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
• Manage, mentor and provide guidance to a team of clinical scientists collaborating with clinical development leadership to foster their professional growth and development.
• Lead, contribute and support Department/Clinical initiatives aimed at improving the quality and content of all clinical programs as well as refining the cross functional/organization processes designed to effectively deliver ArriVent’s portfolio.

Desired Skills and Experiences:

• 10+ years’ experience in clinical development, with a strong focus on the design and conduct of clinical studies in the biotech/pharmaceutical industry is required.
• Clinical Development Solid Tumor Oncology experience required.
• Experience with leading development of protocols and CSRs.
• Demonstrated experience in leading the development of clinical sections of IBs, INDs, NDA, health authority briefing packages, and responses to health authority and IRB requests
• Comfortable and effective working in a small company environment
• Experience mentoring Clinical Scientists and managing and developing direct reports.
• Excellent oral and written communication skills; strong interpersonal skills and a team player.
• Collaborative nature in working with Medical Directors and team members from other functions.
• Self-driven with the ability to function autonomously with minimal direct guidance.

Education:

• PhD, PharmD, or equivalent

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