Senior Director, Contracts and Transactions Counsel

Position Title: Senior Director, Contracts and Transactions Counsel 

Department: Legal 

Reports To: Vice President, Corporate Law and Head of Transactions 

Location: South San Francisco, CA or Princeton, NJ – On-site 4 days per week (Mon to Thurs) 

Job Overview  

Kardigan is seeking an experienced Senior Director, Contracts and Transactions Counsel. This will be a highly strategic and senior-level legal role responsible for providing comprehensive legal guidance on commercial transactions and contracts management, with a core focus on complex clinical development-related agreements This person will serve as a key legal advisor to support business leaders in navigating complex commercial and clinical relationships while supporting the company to meet its objectives. 

This single role can be based in either Princeton, NJ or South San Francisco, CA, and reports to the Vice President, Corporate Law and Head of Transactions. 

Essential Duties and Responsibilities   

Contract Negotiations 

• 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. 

Risk Management & Compliance 

• 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. 

Legal Operations and Technology 

• 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 

Stakeholder Management 

• 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. 

 Clinical Contracting, Privacy, and Research Compliance 

• Serve as the primary legal point of contact for the Clinical Operations team, providing day-to-day legal support on clinical trial execution, vendor management, site-related issues, and cross-functional coordination with regulatory and quality stakeholders, including negotiating and managing CTAs, CRO agreements, investigator agreements, and other clinical vendor agreements. 

• Provide legal guidance on privacy, data protection, and confidentiality matters related to clinical trials, including the handling of patient data and compliance with U.S. and non-U.S. privacy requirements. 

• Advise on informed consent forms (ICFs), including U.S. and ex-U.S. country specific requirements, and related contractual and regulatory considerations. 

• Develop and maintain informed consent (ICF) templates, playbooks, and standardized language to support efficient and compliant execution of clinical trials across U.S. and ex-U.S. jurisdiction.  

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. 

• Ability to operate in a fast-paced, rapidly growing workplace, with a keen interest in providing a consistently high level of service. 

• Able to work independently while exercising initiative and good judgment. 

• Motivated and enthusiastic, with a proactive approach to solving complete legal and business challenges. 

• Assist and support with any special projects and initiatives. 

• Perform other duties as directed by the manager.