Clinical Legal Consultant (Part-Time)

Location: Remote (U.S.-based)

Engagement Type: Part-time, approximately 10–20 hours per week (flexible, with potential to scale as clinical activities expand)

Duration: Initial 6–12 month engagement with potential for extension

Responsibilities

• Draft, review, and negotiate a range of agreements, including:
  • Material Transfer Agreements (MTAs)
  • Confidentiality and Non-Disclosure Agreements (CDAs/NDAs)
  • Clinical Trial Agreements (CTAs) and site agreements, including anticipated Phase 3 study start-up contracting
  • CRO, vendor, and consulting agreements, including amendments and change orders
  • Investigator-initiated trial agreements and research collaborations
• Manage contract templates, playbooks, and fallback positions to enable efficient turnaround.
• Coordinate with the company's outside counsel (Hogan Lovells) on specialized matters (e.g., IP, corporate, and transactional work), helping to scope engagements appropriately and manage external legal spend.
• Support the current General Counsel during a medical leave and transition serving as the primary point of contact for routine legal matters thereafter.
• Maintain organized contract records and support diligence readiness in connection with potential partnering or strategic transactions.

Qualifications

• J.D. from an accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.
• 5-7+ years of relevant legal experience, with significant time in-house at a biotech/pharmaceutical company or in a law firm life sciences transactional practice.
• Deep, hands-on experience negotiating clinical trial agreements and research contracts; familiarity with multi-site, international clinical trial contracting is a strong plus.
• Working knowledge of the regulatory and compliance landscape relevant to clinical-stage drug development (e.g., GCP, anti-kickback considerations in site contracting, data privacy including GDPR as applied to clinical trials).
• Demonstrated ability to work independently with minimal support infrastructure, exercise sound judgment on when to escalate, and use outside counsel efficiently.
• Excellent drafting skills and a practical, business-oriented negotiation style.
• Experience supporting companies through Phase 3 start-up and/or strategic transactions (partnering, M&A diligence) is a plus.

Schedule

Part-time, approximately 10–20 hours per week (flexible, with potential to scale as clinical activities expand).