Clinical Trial Manager

Job Overview

Apogee Therapeutics is seeking a dedicated Clinical Trial Manager in the United States. In this pivotal role, you will be responsible for overseeing the planning, execution, and closing of clinical trials, contributing to the development of novel therapies for immunological and inflammatory disorders.

Company Overview

Apogee Therapeutics is a private biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders. Based in the United States, Apogee Therapeutics is committed to innovative research and development in the field of immunology.

Quick Details

• Salary Range: Market Competitive
• Job Type: Full-time
• Qualifications: Bachelor’s Degree
• Experience: 5 Year+

Key Responsibilities

• Lead and manage all aspects of clinical trial operations from study start-up to close-out.
• Ensure trials are conducted in compliance with GCP, regulatory requirements, and company SOPs.
• Develop and implement essential trial documents, including protocols, informed consent forms, and monitoring plans.
• Oversee the selection, qualification, and management of contract research organizations (CROs) and other vendors.
• Effectively manage study budgets, timelines, and resources to ensure efficient trial progression.
• Collaborate cross-functionally with regulatory, medical affairs, data management, and other internal teams.

Requirements

• Bachelor’s degree in a life science or related field.
• Minimum of 5 years of experience in clinical trial management within the biotechnology or pharmaceutical industry.
• Thorough understanding and application of Good Clinical Practice (GCP) and relevant regulatory guidelines.
• Proven ability to manage complex clinical trials, including multi-center and international studies.
• Excellent communication, leadership, and organizational skills with attention to detail.
• Demonstrated problem-solving abilities and a proactive approach to trial challenges.

Benefits

• Opportunity to make a significant impact on advancing novel therapies for serious diseases.
• Competitive salary and a comprehensive benefits package.
• Work in a dynamic, innovative, and fast-paced biotechnology environment.
• Strong opportunities for professional growth and career development.
• Collaborative and supportive team culture focused on scientific excellence.
• Contribution to improving the lives of patients suffering from immunological disorders.