Senior R&D Legal Counsel, Director (Hybrid)

Job Description

General Summary:

The primary purpose of the Senior R&D Legal Counsel is to independently and proactively provide solutions-oriented legal advice and support to the Research & Development (R&D) business functions on a broad array of matters within a highly regulated environment.  The position reports to the Assistant General Counsel of Regulatory and Development Legal.

Key Duties and Responsibilities:

• Leverages deep domain expertise in R&D legal to provide legal advice, education, and proactive counsel regarding the following:

  • Early research through clinical trials (GxP compliance, research ethics, diversity in clinical trials, subject recruitment and retention, decentralized trials, devices, patient safety and pharmacovigilance, and informed consent, etc.)

  • Biomarker, genomic research and emerging data and digital solutions pertinent to R&D

  • Real World Data and secondary use of research data, and

  • Pre-approval and expanded access to investigational medicinal products

• Proactively identifies and addresses R&D legal issues, fostering trusted relationships with client groups and serving as a standing or ad hoc member of business or leadership teams

• Advises on GxP matters from a global legal perspective in support of research and development activities, namely good laboratory and clinical practices. Responsibilities include counseling on deviations, internal monitoring and audit activities, corrective action plans, global reporting requirements, and GCP and GLP-related inspections, investigations and enforcement actions.

• Monitors drug development industry and policy trends and proactively advises on strategies to shape the landscape and support the success of Vertex’s R&D programs in the context of an evolving and complex external regulatory environment 

• Conceptualizes, designs, and deploys internal legal trainings—raising awareness and organizational knowledge of leading/emerging best practices and solutions in R&D Legal

• Advises on legal questions relating to clinical trial transparency initiatives (e.g., ct.gov and EudraCT requirements, researcher requests for clinical trial data, Policy 0070, provision of plain language summaries under EU Clinical Trial Regulation) and publication considerations

• Additionally, the Senior R&D Legal Counsel:

  • Teams and partners with global legal colleagues to provide comprehensive, integrated and aligned support to the business

  • Contributes to the evolution of R&D legal service delivery, focusing on areas of highest strategic value add and risk mitigation, while continuously improving and seeking alternate solutions for how tactical legal support is enabled

  • Provides agile resourcing support in areas such as regulatory law

  • Serves as a member of various cross-functional teams

  • Drives and contributes to various department and cross-functional governance and process improvement projects

  • Participates in various other Legal & Compliance Department projects and initiatives

Knowledge and Skills:

• Legal Expert: 

  • Advanced depth of knowledge of the laws, regulations and industry standards applicable to the area of responsibility

  • Specific expertise required in statutes, regulations and guidance concerning:  GxP, drug development, early research, clinical trials, trial transparency, and fraud and abuse 

  • Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products

  • Strong analytical and complex problem-solving skills. Sound judgement.

  • Capacity to simultaneously handle a variety of complex legal matters with minimal guidance

• Business-Minded Leader: 

  • Advanced understanding of operations, structures/functions, stakeholders, and objectives, as well as the industry and environment operated in and the way in which the Department contributes to success. This includes the ability to leverage that understanding to provide relevant and actionable counsel.

  • Significant understanding of business drivers, ability to align areas of responsibility to the business strategies

  • Ability to take ownership of issues with greatest impact to the business

• Trustworthy Advisor:

  • Advanced ability to provide a sound recommendation or solution to appropriately assess risk by leveraging one's expertise, and to deliver ethical, practical, trustworthy, and solutions-oriented advice and decisions