Director, Senior Counsel, Global R&D Compliance

Role Summary

The Director, Senior Counsel, Global R&D Compliance provides legal support for current Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) quality, compliance, investigation, and enforcement activities worldwide. It also counsels on clinical trials, research and development, data privacy, pharmacovigilance, and other R&D-related matters; drafts, reviews, and negotiates related agreements; and collaborates with cross-functional teams to support regulatory communications and remediation efforts to advance R&D objectives.

Responsibilities

• Counsel clients on regulatory compliance issues with a focus on current GxP practices, quality processes, and contracting related to the research, development, manufacture, and distribution of innovative, biosimilar, and generic pharmaceuticals, worldwide.
• Collaborate with cross-functional teams to develop and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans.
• Draft, review, and negotiate a wide range of R&D-related agreements, including:
  • Clinical trial agreements
  • Consultancy and service agreements
  • Research collaborations and MTAs
  • Investigator-initiated study agreements
  • Licensing agreements
  • Academic collaboration and research consortium agreements
• Participate in internal meetings to review quality metrics, participate in site or project governance committees, and facilitate internal audits.
• Partner with Compliance to provide legal support for internal investigations.
• Work cross-functionally with Quality, Regulatory, IP, Compliance, Privacy, and other stakeholders to support process and system improvements, including development of global policies and training materials.
• Monitor and participate in the external policy environment and advise teams on policy and regulatory developments related to R&D activities.
• Manage a legal budget and ensure alignment with financial targets.
• Manage outside counsel who provide services in support of this role.
• Provide training to management and employees on emerging and/or hot legal topics.

Qualifications

• A Juris Doctor (JD) degree from a top-tier law school is required.
• A minimum of 7 years prior experience at a law firm and/or in-house legal department.
• Clinical and/or GCP/GLP quality experience highly valued.
• Manufacturing and/or GMP quality experience preferred.
• Solid understanding of legal and regulatory frameworks related to clinical research and drug development.
• Strong contract drafting and negotiation skills.
• Past experience working for a health authority (e.g., FDA, EMA) preferred.
• Admission to practice law in the bar of a relevant jurisdiction/ability to be house counsel.
• Demonstrated ability to understand complex scenarios, identify issues and risks, propose solutions aligned with business objectives, and communicate them clearly.
• Strong interpersonal skills and ability to work collaboratively in global, cross-functional teams.
• Strong relationship-building skills and ability to influence internal and external stakeholders.
• Strong analytical, verbal, and written communication skills.
• Excellent organizational skills and ability to manage multiple responsibilities under deadlines.
• Self-motivation, proactive work style, reliability, and accountability.
• Intellectual curiosity and commitment to continuous learning and improvement.
• Sound judgment and professionalism.
• Up to 15% travel, including international, as needed.

Education

• Juris Doctor (JD) from a accredited law school.

Additional Requirements

• Up to 15% travel, including international, as needed.