Associate Director, Senior Counsel, Clinical

About the Role

In collaboration with the Lead Counsel, Global Clinical Development, you will provide practical, timely, and high-quality legal support to CSL’s Global Clinical Development function on a wide range of legal and regulatory issues. You will act as the primary escalation and resolution point for all clinical contracting legal queries for the Clinical Legal Department.

• Draft, review, and negotiate all agreements as directed by the Lead Counsel, Global Clinical Development, that are not otherwise managed by CRO, procurement, or clinical contracting teams. This includes bespoke agreements for key strategic arrangements involving high risk and complexity, such as clinical trial research agreements, clinical vendor agreements, clinical manufacturing agreements, and clinical trial supply.
• Collaborate with the R&D/Strategy transactional legal team to support clinical development components of agreements, ensuring CDO’s requirements are incorporated and issues appropriately escalated.
• Provide advice on a broad range of legal and regulatory issues related to CSL’s global clinical development activities.
• Serve as a strong business partner for CSL’s Global Clinical organization, ensuring clear communication, collaboration, and proper information flow.
• Conduct research on clinical-related legal and regulatory issues as required by the Lead Counsel or the business.
• Stay informed of clinical legal issues and emerging trends, and generate training content for delivery to the business and clinical contracting teams in collaboration with Clinical Contracts Operations Managers.
• Act as the primary escalation point for legal or contracting issues, escalating unresolved matters to the Lead Counsel as necessary.
• Draft new templates for global clinical development as assigned, review frequently negotiated clauses, reassess risk appetite with the business, and revise clauses accordingly.
• Provide legal advice and support for non-routine special projects and other matters as required by the Lead Counsel, involving strong cross-functional and global collaboration.

Requirements

• Bachelor's Degree required.
• Juris Doctor required.
• Must be licensed to practice law in Pennsylvania or hold (or be eligible for and able to obtain promptly) a Limited In-House Corporate Counsel License under PA BLE Rule 302.
• Minimum of 8 years practicing law, with 5 years of experience in a healthcare environment, preferably pharmaceutical or other organization engaged in clinical research.
• Strong familiarity with global clinical development laws and regulations (including GCP/ICH) and healthcare regulations (including fraud and abuse, anti-kickback, and FDA).
• Experience in an international environment, in-house or private practice, highly desirable.

Skills

• Ability to proactively identify, analyze, and explain potential legal risks and complex issues, developing creative, business-focused solutions to facilitate company objectives while managing risk.
• Strong drafting and negotiation skills, with the ability to produce quality work under pressure and balance multiple priorities.
• Excellent communication, analytical, project management, problem-solving, interpersonal, and teamwork skills.
• Self-motivated team player with a history of successfully resolving challenging legal issues and delivering sound legal advice in a business setting.
• Strong proficiency with Microsoft Office Suite (Word, Outlook, Teams, OneNote, and Excel).

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs, the company discovers, develops, and delivers innovative therapies for conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. CSL Behring uses plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and address unmet medical needs. The company operates one of the world’s largest plasma collection networks, CSL Plasma. CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries.

Schedule

This is a hybrid role, requiring three (3) days of onsite work weekly.

Benefits

For more information on CSL benefits, visit How CSL Supports Your Well-being.