CSL · 5 hours ago
Senior Counsel, Clinical
King of Prussia, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expCSL is a global biotherapeutics leader focused on saving lives through innovative therapies. The Senior Counsel, Clinical Legal will provide high-quality legal support for CSL’s Global Clinical Development function, handling clinical contracting legal queries and ensuring compliance with legal and regulatory issues.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
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)
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 priorities
Strong communication, analytical, project management, problem solving, interpersonal, and teamwork skills are required
Team player, self-motivated, able to demonstrate a history of successfully resolving challenging legal issues, and ability to effectively deliver sound and clear legal advice in a business setting
Strong proficiency with Microsoft Office Suite (particularly with Word, Outlook, Teams, One Note, and Excel)
Periodic travel may be required
Preferred
Experience in an international environment, in-house or private practice, highly desirable
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
Company data provided by crunchbase