Senior Director, Clinical Contracts Attorney

Position Overview

• Location Type: Remote
• Job Type: Full-time
• Salary: Not specified

About Apogee Therapeutics: Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company founded in 2022. It’s a biotechnology company focused on developing differentiated biologics for atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications. Apogee is committed to building an exceptional company culture based on its C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Role Summary

This role involves providing legal contract support for US and global clinical development. You will lead negotiations, draft, and finalize agreements for all phases of clinical development, including clinical trial agreements, informed consent forms, and contract research organization agreements. You will also serve as a legal representative in clinical trial team meetings and provide guidance to third-party vendors. The ideal candidate will be able to independently manage workflows, coordinate efforts with other legal team members, and contribute to maintaining a solid legal and compliance team.

Key Responsibilities

• Provide legal contract support for US and global clinical development.
• Lead negotiations, draft, and finalize agreements for all phases of clinical development, including:
  • Clinical trial agreements
  • Informed consent forms
  • Contract research organization agreements
  • Other trial-related agreements
• Serve as legal representative in clinical trial team meetings, providing input and advice.
• Provide guidance and support to third-party vendors on clinical trial site negotiations.
• Manage legal professionals assisting with clinical contract review, ensuring consistent legal advice on development issues including:
  • Healthcare fraud and abuse
  • Pharmacovigilance
  • Product liability
  • Antitrust
  • Privacy
  • Other matters relevant to the development of innovative investigational agents.
• Actively contribute to maintaining a solid legal and compliance team through discussions, best practices, and collaboration.
• Foster strong and collaborative relationships with legal and non-legal colleagues.
• Actively seek to identify ways to improve processes and tools to enhance efficiencies in the clinical contracting process.
• Develop a thorough understanding of the company’s business, code of responsibility, its people, products, markets, facilities, customers, and competitors.
• Contribute to cultivating a company culture that reflects a strong commitment to ethics and patients and Apogee’s core values.

Requirements

• Expertise in all legal aspects of the operation of clinical trials.
• Experience in biotech industry clinical contracts.
• Ability to independently manage workflows and projects.
• Effective coordination efforts with other legal team members.
• Passion for partnering with internal teams dedicated to the advancement of science and innovation in drug development and patient care.

Application Instructions

• Not specified.