Senior Legal Counsel

Overview

The Senior Legal Counsel is responsible for drafting and negotiating key clinical collaboration agreements through execution. This role also supports other legal and contracting needs across the organization. Reporting within the Legal Department, the Senior Legal Counsel partners with business development, clinical development, clinical operations, medical affairs, finance, research & development, and other internal stakeholders to support business objectives, manage risk, and ensure compliance with company guidelines.

Responsibilities

• Draft, review, and negotiate strategic clinical trial collaboration agreements, including related supply, delivery, and quality agreements.
• Draft, review, 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)
  • Sponsored research agreements
  • Agreements with contract research organizations (CROs)
  • Financing agreements
  • Consulting agreements
  • Master services agreements and related statements of work
  • Vendor and service contracts and related work orders
  • IT software license agreements
  • Confidentiality or non-disclosure agreements
• Serve as the primary contact between internal business units (including Business Development and Strategic Alliances) and external parties, ensuring contractual matters are addressed efficiently and promptly.
• Escalate matters to the Chief Legal Officer or General Counsel as necessary to reduce company risk and help meet business objectives.
• Guide and supervise other attorneys and paralegals in the review and negotiation of contracts, ensuring compliance with Legal Department guidelines, policies, and procedures.
• Build strong working relationships with functional groups and project teams.
• Respond promptly to complex inquiries regarding contract obligations and revisions.
• Identify risks and issues; suggest alternatives that meet business objectives while reducing risk.
• Provide contract status updates to internal clients using established processes, updating processes as necessary.
• Coordinate with IP Counsel, Regulatory Counsel, Commercial Counsel, and the Compliance Department to ensure efficient and appropriate handling of relevant agreement issues.
• Partner with Quality Assurance to ensure appropriate handling of quality-related matters.
• Prepare template agreements, modify existing templates, and develop unique agreements as required.
• Ensure clear and timely communication with employees and external parties regarding contract status and any outstanding issues.
• Support due diligence activities during acquisition of assets as it relates to contract review and assessment.
• Provide training within the legal team and to other business departments as needed on contracting matters.
• Handle miscellaneous legal tasks and special assignments as needed.

Requirements

• Juris Doctor from an accredited law school.
• Admitted to a US state bar in good standing.
• Minimum 7+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company.
• Substantial prior experience as lead attorney for drafting and negotiating Clinical Trial Collaboration Agreements.
• Prior experience drafting and negotiating clinical trial agreements (U.S. and ex-U.S.) with a pharmaceutical company.
• Strong drafting and legal analysis skills, with knowledge of regulations, statutes, and industry guidelines impacting clinical trials, pharmaceutical research, development, and commercial contracts, including data privacy (U.S. and GDPR).
• Proficiency with Word; working knowledge of Microsoft Excel and Teams.
• Experience working with CLM systems and an ability to quickly learn new CLM systems.
• Excellent written and oral communication skills; ability to work effectively with all levels of management and personnel.
• Ability to handle multiple projects in a timely manner.
• Experience handling due diligence related to acquisition and/or divestitures.
• Strong interpersonal skills and a team-player mindset.
• Strong business acumen with the ability to diagnose legal problems and present creative, positive solutions and alternatives.
• Strong organizational and planning skills with meticulous attention to detail.
• Ability to work independently with initiative, flexibility, and good judgment.
• Ability to work well under pressure to meet specific deadlines.
• Flexibility due to a rapidly changing business environment.

Compensation & Benefits

• Pay range: $203,000—$242,563 USD
• Total compensation package may include bonus, stock, benefits, and/or other applicable variable compensation.
• Actual compensation depends on factors including skill set, depth of experience, certifications, and specific work location; compensation may differ by location due to cost of labor.

Location

• Menlo Park, CA; Miami, FL; Princeton, NJ & Remote