Senior Director, Contracts and Transactions Counsel

Essential Duties and Responsibilities

• Draft, review and negotiate a wide range of agreements, including master services agreements, clinical trial agreements (CTAs), license agreements, licensing and collaboration transactions, supply agreements, manufacturing agreements, quality agreements, sponsored research agreements, clinical trial-related vendor agreements, material transfer agreements, and other agreements.
• Provide strategic guidance on transaction structure and contract terms to optimize business outcomes while managing legal risk, particularly in the context of clinical development programs and multi-party clinical collaborations.
• Develop and maintain contract templates, playbooks, and standardized contract terms.
• Identify and mitigate legal risks in business operations and commercial relationships, with particular emphasis on clinical trial contracting, patient data, and regulatory risk.
• Update and improve contract policies and procedures.
• Train business teams on contract policies, procedures, risk management, and other legal practices.
• Evaluate and implement legal technology solutions to improve efficiency and effectiveness, such as contract lifecycle management system.
• Establish metrics and reporting systems to track efficiencies and effectiveness of contracting procedures and other legal practices.
• Manage outside legal consultants and counsels for specialized matters and overflow work, including clinical, regulatory, and privacy counsel as needed.
• Collaborate with and support business development, clinical development, research, and regulatory functions to identify and address legal considerations in new business opportunities.
• Provide strategic advice and counseling in connection with management of collaborations with collaborators, licensees, and other external partners, including those supporting global clinical trials.
• Serve as a legal liaison to the company.

Qualifications and Preferred Skills

• JD degree from an accredited law school with admission to practice law.
• A minimum of 10 years of legal experience with a mix of law firm and in-house experience at pharmaceutical, biotechnology, or medical device companies with a focus on contracts and commercial transactions, including substantial hands-on experience with clinical-development-related agreements.
• Expertise in drafting and negotiating complex agreements.
• Experience providing legal counsel for managing external business relationships and collaborations.
• Solid understanding of intellectual property and privacy and data protection laws as they relate to commercial agreements and clinical trials.
• Knowledge of healthcare, FDA regulations, and other relevant laws applicable to life science business transactions, including laws and regulations impacting clinical research.
• Demonstrated ability to connect the dots across functional areas, identifying how legal issues in one domain may impact other business operations.
• Strong systems thinking approach to understand complex interdependencies and anticipated downstream effects of legal or business decisions.
• Proven track record of translating complex legal concepts into practical business implications.
• Skill in facilitating cross functional dialogue to ensure alignment between legal strategies and business objectives.
• Experience serving as a bridge between technical, business and legal stakeholders to drive to solutions.
• Strong organizational and planning skills, ability to manage changing priorities and workflow, and the ability to effectively advance multiple simultaneous projects.
• Strong interpersonal and written and verbal communication skills, with an ability to communicate and collaborate with individuals at all levels inside and outside of the organization in a positive and effective manner.
• Able to work independently while exercising initiative and good judgment.
• Motivated and enthusiastic, with a proactive approach to solving complete legal and business challenges.

Pay Range

$263,000 - $357,000 USD