Description:
Managing Member: Varies by Location of InterestPractice Group/Leader: Health Care/Eric Klein
Department/Director: Regulated Industries/Courtney Kissel
Key Responsibilities include:
Lead the drafting, review, negotiation, and strategic structuring of complex health care and life sciences agreements, including:
- Clinical Trial Agreements (CTAs)
- Data Use Agreements (DUAs)
- Material Transfer Agreements (MTAs)
- Business Associate Agreements (BAAs)
- Related research collaboration and commercial agreements
- Advise clients on compliance with applicable regulatory frameworks, including FDA regulations, the Common Rule, ICH-GCP guidelines, HIPAA, and research-specific data privacy and security requirements.
- Provide practical, business-oriented guidance on clinical research operations, risk allocation, and regulatory strategy across the research lifecycle.
- Develop, refine, and oversee policies, templates, and contracting frameworks for clinical research and life sciences clients.
- Collaborate with partners and senior attorneys on sophisticated regulatory and transactional matters.
- Mentor and support junior attorneys and associates, as appropriate.
- Participate in practice development initiatives and client relationship management.
Qualifications:
- J.D. from an accredited law school and active membership in good standing with at least one state bar.
- 6+ years of experience practicing health care and/or life sciences law, preferably in a law firm or in-house role with substantial responsibility for clinical research or regulated health care matters.
- Demonstrated experience independently drafting and negotiating CTAs, DUAs, MTAs, BAAs, and related agreements.
- Strong working knowledge of clinical research compliance frameworks, including FDA, the Common Rule, HIPAA, and ICH-GCP.
- Ability to manage complex matters independently while collaborating effectively in a team-based environment.
- Excellent analytical, drafting, and communication skills with a strong client-service orientation.
Why Dykema?
- Realistic path to partnership
- Multiple mentoring opportunities
- Direct partner and client access
- Competitive billing expectations
- Billable credit for pro bono work and approved firm activities
- Structured professional development opportunities
- Dynamic and inclusive culture