Corporate Counsel, Clinical Contracts

Overview

A biopharmaceutical oncology organization is seeking a Corporate Counsel, Clinical Contracts to support the review, negotiation, and execution of contracts across multiple departments. This role partners with clinical, quality, medical affairs, finance, research & development, HR, IT, and other internal teams to draft and negotiate contracts that mitigate risk, support business objectives, and ensure compliance with company policies.

Responsibilities

• Collaborate with attorneys and legal staff across practice areas to identify and address key legal issues for business teams.
• Draft, review, analyze, and negotiate clinical-related contracts, including:
  • Clinical trial agreements and ancillary agreements (clinical study service, quality, pharmacy, radiology agreements)
  • Investigator sponsored studies (ISTs)
  • Collaboration and development agreements
  • Sponsored research agreements
  • Contracts with contract research organizations (CROs)
• Draft and negotiate consulting agreements, master services agreements and statements of work, promotional speaker bureau agreements, vendor and service contracts, IT software license agreements, HR benefit and contractor agreements, leases, and confidentiality/non-disclosure agreements.
• Serve as liaison between internal business units and external parties to ensure efficient and prompt handling of legal and contractual matters; escalate issues as needed to reduce risk and meet business goals.
• Respond promptly to complex inquiries regarding contract obligations and revisions.
• Identify risks and propose alternatives that align with business objectives while minimizing risk.
• Review and track ongoing agreements.
• Support employees regarding the contract management process.
• Coordinate with Intellectual Property Counsel on intellectual property issues in agreements.
• Collaborate with Regulatory Counsel and Compliance teams on regulatory and compliance matters related to contracts.
• Work with Quality Assurance to address quality-related contract issues.
• Prepare and modify template agreements and draft unique agreements as required.
• Maintain clear and timely communication with employees and external parties regarding contract status and issues.
• Perform miscellaneous legal tasks or special assignments as needed.

Requirements

• Juris Doctorate from an accredited law school.
• Admission to a U.S. state bar in good standing.
• Minimum of 5 years of experience in a major law firm and/or in-house legal department within pharmaceutical, medical device, or healthcare sectors.
• At least 2 years of experience reviewing and negotiating Clinical Trial Agreements (U.S. and international).
• Strong drafting and legal analysis skills.
• Knowledge of regulations, statutes, and industry guidelines affecting pharmaceutical research, development, and commercial contracts, including data privacy.
• Proficiency with Microsoft Word; working knowledge of Excel and Microsoft Access.
• Excellent written and oral communication skills.
• Ability to work effectively with all levels of management and personnel.
• Strong organizational and planning skills with meticulous attention to detail.
• Self-starter capable of working independently and collaboratively.
• Ability to manage competing priorities in a fast-paced environment and exercise sound commercial and legal judgment.
• Flexibility to adapt to a rapidly changing business environment.

Compensation & Benefits

• Salary range: $158,000 - $185,000 USD.
• Actual compensation depends on factors such as skill set, experience, certifications, and work location.
• Total compensation may include bonus, stock options, benefits, and other variable components.

Location

The organization is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.