Assistant General Counsel, Clinical

Role Overview

• Serve as the company’s primary legal advisor for contracts, with input from the CLO and General Counsel, in the negotiation of contracts across all departments, including clinical operations, R&D, medical affairs, business development, human resources, IT, finance, manufacturing, quality, commercial and facilities
• Pro-actively update company guidelines, policies, SOPs related to contract review and processes for efficiency, effectiveness, and changes to applicable law; ensure the Contracts Team and relevant business departments are trained on any new policies and procedures
• 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), strategic clinical trial collaboration agreements, sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft, review and negotiate financing agreements, collaboration and partnership agreements, 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, and confidentiality or non-disclosure agreements.
• Supervise and promptly address contract escalations from more junior attorneys and paralegals in the review and negotiation of contracts ensuring compliance with all Legal Department guidelines, policies and procedures
• Review and revise Legal Department guidelines, policies and procedures related to the contract review lifecycle (intake, review and negotiation, execution).
• Serve as the legal liaison between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters to the General Counsel, as necessary, to reduce company risk and help ensure company business objectives are met.
• Promptly respond to complex inquiries regarding contract obligations and revisions
• Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk
• Actively seek 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
• Work with Quality Assurance to ensure appropriate handling of quality matters.
• Prepare template agreements, modify existing templates and prepare unique agreements as necessary to ensure compliance with applicable law and internal guidelines; ensure the Contracts Team is timely informed and trained on any revised templates and contracting processes
• Oversee the company’s CLM for the Legal Department; propose continuous process improvements and work with the IT Department to make any necessary changes and provide necessary training to the Contracts team and other departments
• Ensure clear and prompt communication with company employees, and outside parties regarding contract status and any outstanding issues
• Handle miscellaneous legal tasks or special assignments on an as-needed basis
• All other duties as assigned

Requirements

• Juris Doctorate from an accredited law school, and admitted to a U.S. state bar in good standing
• Minimum of 10+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company, with a minimum of 5+ years reviewing and negotiating Clinical Trial Agreements (U.S. and ex-U.S), ISTs, and Clinical Trial Collaboration Agreements
• 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)
• Ability to make decisive decisions in contract escalations to support business objectives while minimizing legal risk
• Must be able to provide practical advice to the business teams in clear and concise language
• Proficient with Word and have a working knowledge of Microsoft Excel and Teams as well as ability to quickly learn CLM used by the company
• Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel
• Strong organizational and planning skills and meticulous attention to detail
• Self-starter with the ability to work independently as well as collaboratively in a team environment
• Must be able to lead by example with strong managerial and interpersonal skills
• Prior experience managing multiple attorneys and legal professionals required
• Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment
• Must be flexible due to rapidly changing business environment for a growth company.

Benefits

• Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
• This may be different in other locations due to differences in the cost of labor.
• The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.