Senior Counsel, Clinical

In collaboration with the Lead Counsel, Global Clinical Development, the Senior Counsel, Clinical Legal 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. This includes acting as the primary escalation and resolution point for all clinical contracting legal queries for the Clinical Legal Department.

• In support of the Clinical Development team, 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 will include a range of bespoke agreements for which templates do not exist, for arrangements that are of key strategic importance for CDO and involve a high level of risk and complexity.
  
  Agreement types include but are not limited to 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 all clinical development components of the agreements supported by that team, ensuring CDO’s requirements are incorporated, and any issues appropriately escalated.
• Provide advice with respect to a broad range of legal and regulatory issues related to CSL’s global clinical development activities.
• Provide strong business partnering support for CSL’s Global Clinical organization, ensuring clear communication, strong collaboration and proper information flow.
• Undertake any research on a range of clinical related legal and regulatory issues, as required by the Lead Counsel, Global Clinical Development, or the business.
• Stay apprised of and generate training content on clinical legal issues and emerging external trends as required by the Lead Counsel, Global Clinical Development and Global Lead, Clinical Contracting for delivery to the business and to the clinical contracting teams. Work in collaboration with the Clinical Contracts Operations Managers to efficiently deliver training content.
• Act as the primary escalation and resolution point for any legal or contracting issues raised, and if necessary, escalate any unresolvable issues to the Lead Counsel, Global Clinical Development.
• Draft, as assigned by Lead Counsel, Global Clinical Development, new templates required to support global clinical development. Review frequently negotiated agreement clauses, collaborate with the business to reassess the company’s risk appetite (as needed) and revise clauses accordingly.
• As assigned, provide legal advice and support in connection with non-routine special projects for Global Clinical Development and for other matters or areas that business needs may dictate, or as otherwise required by the Lead Counsel, Global Clinical Development. This will require strong cross functional, global collaboration.

• 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).
• Experience in an international environment, in-house or private practice, highly desirable.
• Ability to proactively identify, analyze, and effectively explain potential legal risks and complex legal issues to clients and develop creative and business-focused advice and solutions in order to facilitate the business objectives of the company while effectively managing risk.
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client groups.
• Strong drafting and negotiation skills required, as well as ability to produce quality work under pressure and while balancing multiple…