Senior Legal Counsel

Job Title: Senior Legal Counsel

Department: Legal

Location: Menlo Park, CA; Miami, FL; Princeton, NJ & Remote

SENIOR LEGAL COUNSEL

Overview of Role:

The Senior Legal Counsel is primarily responsible for drafting, and negotiating to execution key clinical collaboration agreements. This position will also support other legal and contracting needs of the company. This position is within the Legal Department and partners with business development, clinical development, clinical operations, medical affairs, finance, research & development, and other internal clients from other departments to support company business objectives, protect the company from risk, and ensure compliance with company guidelines.

Role and Responsibilities:

Draft, review and negotiate strategic clinical trial collaboration agreements, including related supply, delivery and quality agreements, with business development, research and development, and commercial partners.

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, and agreements with contract research organizations (CROs). In addition, may draft, review and negotiate financing agreements, consulting agreements, master services agreements and related statements of work, vendor and service contracts and related work orders, IT software license agreements, and confidentiality or non-disclosure agreements.

Acts as the primary contact between internal business units, including the Business Development and Strategic Alliance team, and external parties, ensuring that all legal and 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 ensure company business objectives are met.

• Provide guidance and supervise other attorneys and paralegals in the legal department in the review and negotiation of contracts ensuring compliance with all Legal Department guidelines, policies and procedures
• Develop strong working relationships with functional groups and project teams.
• Promptly respond to complex inquiries regarding contract obligations and revisions.
• Identify risks and issues, suggest alternatives that meet company business objectives while also reducing company risk.
• Reports the status of contracts to internal clients using established processes and updated processes as necessary.
• Actively seeks feedback and advice from IP Counsel, Regulatory Counsel, Commercial Counsel, and the Compliance Department to ensure efficient and appropriate handling of relevant issues in agreements
• Works 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 company employees, and outside parties regarding contract status and any outstanding issues
• Support due diligence activities during acquisition of assets as it relates to review and assessment of contracts.
• Provide training within the legal team and to other business departments as needed regarding contracting matters.
• Handle miscellaneous legal tasks or special assignments on an as-needed basis.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills:

• Juris Doctorate from an accredited law school and admitted to a US state bar in good standing.
• Minimum of 7+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company
• Must have substantial prior experience as lead attorney for drafting and negotiating Clinical Trial Collaboration Agreements
• Prior clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company
• Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting clinical trials, pharmaceutical research, development and commercial contracts, including data privacy (U.S. and GDPR)
• Proficient with Word and have a working knowledge of Microsoft Excel and Teams and experienced working with CLM systems and an ability to quickly learn new CLM systems.
• Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel.
• Able to handle multiple projects in a timely manner
• Experienced in handling due diligence with acquisition and/or divestitures
• Strong interpersonal skills including a strong sense of being a team player
• A keen understanding of business and the ability to diagnose legal problems and present positive, creative solutions and alternatives for management
• Strong organizational and planning skills and meticulous attention to detail
• Able to work independently while exercising initiative, flexibility and good judgment
• Works well under pressure to meet specific deadlines
• Must be flexible due to rapidly changing business environment for a growth company