Senior Clinical Research Counsel

Overview

A leading organization in the Pharmaceuticals & Biotech sector is seeking a Senior Clinical Research Counsel. This role focuses on providing business-aligned legal guidance related to governance, compliance, and operational risk management within clinical research. The position involves partnering with leadership, compliance teams, and cross-functional groups to translate complex legal and regulatory issues into practical recommendations that support responsible execution, improved decision-making, and sustainable growth in a life sciences environment.

Location: Remote (U.S. based candidates only; no visa sponsorship available)

Compensation: $200,000 – $220,000 annually

Responsibilities

• Negotiate clinical trial agreements (CTAs) for multi-site, multi-country clinical trials
• Advise on contracting risks and develop mitigation strategies
• Ensure compliance with applicable federal, state, and international laws and regulations
• Assist with legal aspects of patient informed consent forms
• Develop and negotiate data protection and privacy agreements
• Create policies addressing anti-kickback considerations
• Identify and implement process improvements for contract lifecycle management

Requirements

• Juris Doctor (JD) degree
• Membership in a State Bar Association (preferably California)
• Minimum of 10 years of legal experience in a large law firm or legal department within the Life Sciences or Pharmaceutical sector
• Expertise in drafting and negotiating clinical trial agreements
• In-depth knowledge of laws and regulations governing clinical research, including FDA regulations, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines
• Strong organizational, communication, analytical, and decision-making skills

Preferred Qualifications

• Experience with contract lifecycle management (CLM) systems
• Familiarity with data privacy laws such as HIPAA and GDPR
• Knowledge of anti-kickback regulations and international law related to clinical research
• Proficiency with contract negotiation and e-signature software (e.g., DocuSign, Adobe Sign)
• Experience using risk management tools to assess and mitigate regulatory compliance risks
• Ability to collaborate effectively using communication platforms such as Slack or Microsoft Teams

Benefits

• Medical, dental, and vision insurance options
• Health and financial wellness programs
• 401(k) retirement plan with company match
• Unlimited paid time off (PTO) for exempt employees
• Paid holidays (11 annually) and various leave options
• Employee Assistance Program (EAP)
• Voluntary legal services and identity theft protection

The employer is an equal opportunity organization and encourages applications from candidates who may not meet every qualification but bring valuable backgrounds and perspectives to the team.