Overview
A leading organization in the Pharmaceuticals & Biotech sector is seeking a Senior Director - Counsel Clinical Development Regulatory Legal. This role involves providing legal leadership at the intersection of scalable technology, AI-enabled capabilities, and business transformation within clinical development. The position requires collaboration across engineering, product, and business teams to translate complex requirements into practical technology solutions, influencing architecture, execution quality, and long-term innovation.
Location: Remote (U.S. based candidates only, no visa sponsorship available)
Compensation: $195,000 – $314,600 annually
Responsibilities
- Provide legal counsel for clinical development programs, focusing on both U.S. and global initiatives
- Partner with Clinical Trials Capabilities teams to deliver practical legal guidance on operational processes
- Support AI and automation projects in clinical operations by advising on legal and regulatory implications
- Advise on Good Clinical Practice (GCP) compliance and inspection readiness related to clinical trial quality
- Monitor evolving global regulatory expectations and translate them into actionable guidance
- Influence internal and external collaborators to advance regulatory policy initiatives
Requirements
- Juris Doctor (J.D.) degree from an accredited law school
- Active U.S. state bar license
- 5-10 years of experience as an in-house lawyer within pharmaceutical or medical device industries
- Strong knowledge of regulatory laws impacting clinical development and GCP compliance
- Proven ability to manage high volumes of input and prioritize effectively
- Experience influencing regulatory policy initiatives and collaborating across multiple functions
Preferred Skills and Experience
- Expertise in Good Clinical Practice (GCP) compliance and clinical trial documentation (e.g., informed consent forms, clinical trial site agreements)
- Legal expertise on global regulatory laws
- Familiarity with AI and automation applications in clinical development
- Experience with clinical trial operations and regulatory agencies
- Proficiency with contract management systems, regulatory compliance software, data analytics tools, project management tools, legal research databases, and collaboration platforms
Benefits
- Participation in a company-sponsored 401(k) plan and pension
- Comprehensive medical, dental, vision, and prescription drug coverage
- Flexible spending accounts for healthcare and dependent care
- Access to life insurance and various leave benefits
- Well-being programs including employee assistance and fitness benefits
Equal Opportunity
The employer is an equal opportunity organization and encourages applications from candidates who may not meet every qualification but whose backgrounds could contribute to the team.