Director, Senior Counsel, Global R&D Compliance

Role Summary

The Director, Senior Counsel, Global R&D Compliance provides legal support for current GCP/GLP quality, compliance, investigation, and enforcement activities worldwide. It includes reviewing and negotiating agreements related to clinical trials, research and development, data privacy, pharmacovigilance, and other R&D matters. The role counsels on regulatory compliance issues with a focus on GCPs/GLPs, collaborates with cross-functional teams, and supports communications with global regulators, inspections, and remediation plans. This hybrid role is based in West Chester, PA (may consider Parsippany, NJ or remote for the right candidate).

Responsibilities

• Counsel clients on a wide range of 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.
• Work collaboratively 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

• Required: A Juris Doctor (JD) degree from a top-tier law school.
• Required: A minimum of 7 years prior experience at a law firm and/or in-house legal department.
• Preferred: Clinical and/or GCP/GLP quality experience.
• Preferred: Manufacturing and/or GMP quality experience.
• Required: Solid understanding of legal and regulatory frameworks related to clinical research and drug development.
• Required: Strong contract drafting and negotiation skills.
• Preferred: Past experience working for a health authority (e.g., FDA, EMA).
• Required: Admission to practice law in the bar of a relevant jurisdiction/ability to be house counsel.
• Required: Ability to understand complex scenarios, identify issues and risks, propose business-aligned solutions, and communicate clearly.
• Required: Strong interpersonal skills and ability to work collaboratively in global, cross-functional teams.
• Required: Strong relationship-building skills and credibility across internal and external stakeholders.
• Required: Strong analytical, verbal, and written communication skills; excellent organizational skills and ability to manage multiple responsibilities.
• Required: Self-motivation, initiative, reliability, and accountability; continuous learning mindset; sound judgment and professionalism.
• Required: Up to 15% travel, including international, as needed.

Skills

• Regulatory compliance expertise in GCP/GLP, quality processes, and contracting for R&D
• Legal drafting and negotiation across clinical trials, collaborations, MTAs, and licensing
• Cross-functional collaboration and regulatory communications with health authorities
• Training and capability development within management and staff
• Budget management and oversight of external counsel

Education

• Juris Doctor (JD) from a accredited law school