Corporate Counsel, Clinical Contracts

Overview

This position supports the Legal Department by managing the review, negotiation, and execution of company contracts across multiple departments. You will partner with teams including clinical, quality, medical affairs, finance, research & development, HR, IT, and other internal stakeholders to draft and negotiate agreements that protect the organization, support business objectives, and ensure compliance with company guidelines.

Responsibilities

• Collaborate with attorneys and other legal staff across practice areas to proactively identify and address key legal issues for business teams.
• Draft, review, analyze, and negotiate clinical-related contracts, including:
  • Clinical trial agreements (including ancillary agreements such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements)
  • Investigator sponsored studies (ISTs)
  • Collaboration and development agreements
  • Sponsored research agreements
  • Agreements with contract research organizations (CROs)
• May draft and negotiate other agreements, including:
  • Consulting agreements
  • Master services agreements and related statements of work
  • Promotional speaker bureau agreements
  • Vendor and service contracts and related work orders
  • IT software license agreements
  • HR benefit and contractor agreements
  • Leases
  • Confidentiality or non-disclosure agreements
• Liaise between internal business units and external parties to ensure legal and contractual matters are addressed efficiently and promptly; escalate matters as necessary to reduce company risk and help ensure business objectives are met.
• Promptly respond to complex inquiries regarding contract obligations and revisions.
• Identify risks and issues; propose alternatives that meet business objectives while reducing risk.
• Review and track in-process and on-going agreements.
• Support employees regarding the Contract Management process.
• Coordinate with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements.
• Coordinate with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters.
• Coordinate with Quality Assurance to ensure appropriate handling of quality matters.
• Prepare template agreements, modify existing templates, and prepare unique agreements as required.
• Ensure clear and prompt communication with employees and outside parties regarding status of, or issues in, contracts.
• Handle miscellaneous legal tasks or special assignments as needed.
• Perform other duties as assigned.

Requirements

• Juris Doctor from an accredited law school.
• Admitted to a US state bar in good standing.
• Minimum of 5+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company.
• Minimum of 2+ years reviewing and negotiating Clinical Trial Agreements (U.S. and ex-U.S.).
• Precise drafting and strong legal analysis skills.
• Knowledge of regulations, statutes, and industry guidelines impacting pharmaceutical research, development, and commercial contracts, including data privacy.
• Proficient with 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 able to work independently and collaboratively in a team environment.
• Ability to manage competing priorities in a fast-paced environment and exercise sound commercial and legal judgment.
• Flexibility due to a rapidly changing business environment.

Compensation & Benefits

• Base Pay Range: $158,000 - $185,000 USD
• Actual compensation packages are based on factors including skill set, depth of experience, certifications, and specific work location. Total compensation may include bonus, stock, benefits, and/or other applicable variable compensation.

Location

• Based in Miami, Florida. The organization also has additional offices in California, New Jersey, the UK, and Ireland.

Equal Opportunity

This employer is an Equal Opportunity Employer and does not discriminate in recruitment, hiring, training, or promotion (or any other employment practices) on the basis of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.