Description:
Who You Are:We are seeking a highly experienced and dynamic Senior Counsel at the Associate Director/Director level to join our legal team. This pivotal role requires a seasoned legal expert with a comprehensive skill set across three core areas: clinical expertise, data privacy (including GDPR and US privacy laws), and commercial contracts/legal operations. The ideal candidate will possess deep legal knowledge in the biotech sector, exceptional problem-solving abilities, and a proactive approach to managing complex legal challenges and opportunities.
Responsibilities:
Clinical Expertise:
- Provide comprehensive legal support for various clinical agreements, including Material Transfer Agreements (MTAs), Clinical Trial Agreements (CTAs), confidentiality agreements, Master Service Agreements (MSAs), general services and licenses, Sponsored Research Agreements (SRAs), collaborations, and sponsored research
- Offer guidance on clinical-related legal issues, including publications, inspections, and regulatory compliance, ensuring alignment with ethical standards and laws
- Collaborate with client clinical operations and clinical development leaders, develop a strong understanding of their strategic objectives, and act as a thought partner for them to achieve their goals
- Liaise with internal teams and external partners to negotiate, draft, and review agreements, ensuring they meet the organization's objectives and compliance requirements
- Manage privacy/data protection related matters in the context of clinical trials and R&D, throughout the company and affiliates. This includes advising and reviewing ICFs, privacy notices, Data processing agreements etc., lead DPIAs, data mapping
- Actively support the organization's privacy compliance program, advise and propose data privacy policies and practices, ensuring compliance with applicable data protection laws globally, and other applicable regulations in the biotech industry. Member of the data breach response team
- Provide strategic advice on data privacy and protection matters. Carry out risk assessment, management of data incidents, and compliance training for staff. Play an active role in the implementation of privacy management tools
- Collaborate with IT, security, and other relevant departments to develop and implement data privacy strategies and policies
- Manage the full lifecycle of commercial contracts, including drafting, negotiating, and executing a wide range of agreements to support the organization's commercial activities
- Lead legal operations related to commercial contracts, including refining and managing the contract policy, overseeing the contract management system, and advising on refinancing activities
- Serve as a key legal advisor on commercial transactions, providing strategic input to ensure contracts align with the company's business objectives and risk tolerance
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
- Juris Doctor (JD) degree from an accredited law school
- Admission to practice law in at least one U.S. jurisdiction
- Preferred: 10 years or more of legal experience, with a strong preference for candidates who have experience in the biotech or pharmaceutical industry
- Expertise in clinical agreements, data privacy (including GDPR and US privacy laws), and commercial contracts/legal operations
- Demonstrated ability to manage complex legal issues and provide strategic, proactive legal advice
- Strong negotiation, drafting, and analytical skills
- Excellent communication and interpersonal abilities, with a track record of building effective relationships with both internal teams and external partners
- Ability to work independently, manage multiple priorities, and thrive in a fast-paced environment
