Counsel – Clinical Legal

Counsel – Clinical Legal

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 health care environment, preferably pharmaceutical or other organization engaged in clinical research.
• Strong familiarity with global clinical development laws and regulations (including GCP/ICH), and health care regulations (including fraud and abuse, anti-kickback, and FDA).
• Strong drafting and negotiation skills required, as well as ability to produce quality work under pressure and while balancing multiple priorities.
• Strong communication, analytical, project management, problem solving, interpersonal, and teamwork skills are required.
• Strong proficiency with Microsoft Office Suite (particularly with Word, Outlook, Teams, One Note, and Excel).

Responsibilities

• Draft, review, and negotiate all agreements as directed by the Lead Counsel, Global Clinical Development, that are not managed by Counsel, Clinical Vendors, or the Clinical Contracts Specialist Team (CCST).
• Collaborate with the R&D/Strategy transactional legal team to support all clinical development components of agreements, ensuring CDO’s requirements are incorporated and issues are appropriately escalated.
• Provide advice on a broad range of legal and regulatory issues related to CSL’s global clinical development activities.
• Offer strong business partnering support for CSL’s Global Clinical organization, ensuring clear communication, strong collaboration, and proper information flow.
• Conduct research on clinical-related legal and regulatory issues as required by the Lead Counsel, Global Clinical Development, or the business.
• Stay updated on clinical legal issues and emerging trends, generating training content for delivery to the business and the CCST in collaboration with the Clinical Contracts Operations Manager.
• Act as the primary escalation and resolution point for legal or contracting issues raised by the Clinical Contracts Project Managers, escalating unresolvable issues to the Lead Counsel, Global Clinical Development if necessary.
• Draft new templates required to support global clinical development, review frequently negotiated agreement clauses, and collaborate with the business to reassess the company’s risk appetite and revise clauses accordingly.
• Provide legal advice and support for non-routine special projects for Global Clinical Development and other matters as required by the Lead Counsel, Global Clinical Development, involving strong cross-functional, global collaboration.

Preferred Qualifications

• Experience in an international environment, in-house or private practice, highly desirable.