Associate Director, Senior Counsel, Clinical

CSL; King of Prussia (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

CSL Behring seeks an Associate Director, Senior Counsel, Clinical, to provide timely legal support to Global Clinical Development. You will be the primary escalation point for clinical contracting queries, drafting and negotiating key agreements, and supporting global development programs.

This is a hybrid role in King of Prussia, PA requiring three onsite days weekly. The ideal candidate has a JD, PA eligibility, 8+ years of legal practice (5 in healthcare or pharma), and strong

Qualifications

• Bachelor's Degree required.
• Juris Doctor required.
• Must be licensed to practice law in Pennsylvania or eligible for PA BLE Rule 302 in-house license.
• Minimum of 8 years practicing law, with 5 years in health care/pharma.
• Strong knowledge of GCP/ICH and healthcare regs (fraud/abuse, anti-kickback, FDA).

Responsibilities

• Draft, review, and negotiate clinical agreements directed by Lead Counsel.
• Provide legal advice on regulatory issues for CSL's Global Clinical Development.
• Escalate and resolve legal/contracting issues; partner with cross-functional teams.
• Develop training content on clinical legal issues and trends.
• Draft new templates for global clinical development support.

Skills

Juris Doctor

PA license eligibility

Health care experience

GCP/ICH knowledge

FDA regulations

Drafting & negotiation

Cross-border experience

MS Office proficiency

Education

Bachelor's Degree

Juris Doctor

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Job description

The Opportunity

In collaboration with the Lead Counsel, Global Clinical Development, as the Associate Director, Senior Counsel, Clinical, 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. This is a hybrid role, requiring three (3) days of onsite work weekly. #LI-hybrid

The Role

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, elevate 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.

Your Skills & Abilities

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 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).

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

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

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer.

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