Director, Corporate Counsel, R&D

BioMarin Pharmaceutical•San Rafael, CA

12d

About The Position

The Director, Corporate Counsel, R&D serves as a strategic legal partner to Worldwide Research and Development (WWRD), providing practical, business-focused legal advice for global research and clinical development activities. The role independently advises R&D leaders and cross-functional teams on legal matters throughout the development lifecycle, including research, global clinical trials, clinical operations, data privacy and clinical or research data, collaborations, and contracting. The Director identifies and helps manage legal risk while enabling R&D priorities, and works with Research, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Privacy, Compliance, and other functions to develop scalable legal processes, contracting approaches, and resources. The position provides legal guidance on clinical studies, research activities, agreements, clinical and research documentation, and applicable laws, regulations, and industry standards. It also serves as a senior escalation point for complex or non-standard R&D contracting matters, helps guide contracts professionals and Legal colleagues, and develops tools, templates, training, and process improvements to support efficient and consistent legal services. The role monitors relevant legal and industry developments, communicates their potential impact, and supports strategic R&D initiatives and Legal department priorities as needed.

Requirements

Juris Doctor (J.D.) degree from an accredited law school.
Active member in good standing of at least one U.S. state bar and eligible to practice as in-house counsel in California, as applicable.
Approximately 8 or more years of relevant legal experience.
Meaningful experience advising on legal matters relating to pharmaceutical or biotechnology research, clinical development, or clinical operations.
Significant experience drafting, reviewing, and negotiating complex agreements.
Demonstrated ability to operate independently and serve as a trusted legal advisor to business and functional leaders.
Excellent legal judgment and ability to assess legal risk, distinguish material risks from manageable business risks, and recommend practical solutions.
Strong understanding of the legal and regulatory environment applicable to pharmaceutical and biotechnology research and development.
Working knowledge of data privacy and data protection considerations relevant to global R&D activities, including recognizing when specialized Privacy counsel should be engaged.
Strong drafting and negotiation skills, including handling complex and non-standard contractual issues.
Ability to translate complex legal, regulatory, and privacy requirements into clear, practical guidance for scientific, clinical, and business stakeholders.
Strong strategic thinking and problem-solving skills, with ability to understand scientific and business objectives and incorporate them into legal advice.
Excellent interpersonal and influencing skills and ability to collaborate across Legal and highly matrixed cross-functional teams.
Ability to manage multiple priorities, exercise sound judgment, and work autonomously in a fast-paced environment.
Ability to identify process improvements and develop scalable legal tools, templates, and approaches.
Excellent written and verbal communication skills, including explaining complex legal issues to stakeholders with varying levels of legal expertise.
Self-starter who takes ownership while recognizing when to engage subject-matter experts or escalate significant issues.
High degree of integrity, professionalism, accountability, and commitment to quality.

Nice To Haves

Relevant experience in the biotechnology or pharmaceutical industry and/or at a law firm advising life sciences clients.
Experience with clinical trial agreements, CRO and clinical vendor agreements, research agreements, and other agreements supporting R&D activities.
Knowledge of FDA and EMA regulatory frameworks, ICH Good Clinical Practice, and data privacy and protection requirements relevant to global clinical research.
Experience advising cross-functional teams and working effectively within a complex, global, highly matrixed organization.

Responsibilities

Serve as a primary legal advisor to assigned R&D functions, programs, and teams, providing strategic, practical, solutions-oriented counsel throughout research and clinical development.
Advise on legal issues associated with global Phase 1 through Phase 4 clinical studies, registries, and related development activities, including trial conduct, informed consent, data privacy, data handling and transfers, research activities, and interactions with research partners.
Draft, negotiate, and advise on agreements supporting R&D, including clinical trial, CRO, clinical vendor, research, consulting, confidentiality, and data-use agreements.
Partner with R&D stakeholders to structure arrangements and develop solutions balancing legal, regulatory, and privacy risk with scientific, operational, and business objectives.
Identify, assess, and communicate material legal risks, and recommend actionable risk mitigation and resolution to R&D leaders and other decision-makers.
Review and advise on clinical trial and research-related documents, including informed consent forms, privacy notices, data-use documentation, and clinical trial submission materials.
Provide guidance on laws, regulations, and industry standards governing clinical research and development, including FDA and EMA requirements, ICH Good Clinical Practice, and applicable data privacy and protection requirements.
Work across Legal and with R&D stakeholders to resolve novel or complex legal issues that could affect research or development activities.
Serve as a senior escalation point for complex or non-standard R&D contracting matters and guide contracts professionals and other Legal colleagues.
Develop and improve contract templates, playbooks, guidance, and other resources to support efficient, consistent, scalable R&D legal support.
Identify opportunities to streamline legal and contracting processes, clarify roles and decision rights, and appropriately use standardized approaches and technology.
Provide training and education to R&D teams, contracts professionals, and other stakeholders on contracting, clinical research, data privacy, and other relevant legal topics.
Monitor developments in laws, regulations, and industry practices relevant to research and clinical development and advise stakeholders of potential organizational impacts.
Promote collaboration and effective communication among Legal, R&D, and other cross-functional stakeholders.
Support other strategic R&D initiatives and Legal department priorities as needed.
Support the organization’s environmental protection, injury prevention, and continual improvement commitments by identifying hazards, reporting incidents, and participating in EHS initiatives and training.