Director, Corporate Counsel, R&D

BioMarin Pharmaceutical Inc.•San Rafael, CA

19d

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 counsel in support of global research and clinical development. The role independently advises R&D leaders and cross-functional teams on legal matters throughout the development lifecycle, including research activities, global clinical trials, clinical operations, data privacy and the collection, use and sharing of clinical and research data, collaborations, and contracting. The Director identifies and helps manage legal risk while enabling the efficient advancement of R&D priorities. The position partners with teams across Research, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Privacy, Compliance, and other functions. It also develops scalable legal processes, contracting approaches, templates, playbooks, guidance, and training resources to support the evolving needs of the R&D organization. The role advises on global Phase 1 through Phase 4 clinical studies, registries, clinical trial conduct, informed consent, and interactions with clinical research organizations, investigators, hospitals, universities, and other research partners. It drafts, negotiates, and advises on agreements supporting R&D, and provides guidance on applicable laws, regulations, and industry standards, including FDA and EMA requirements, ICH Good Clinical Practice, and global data privacy and data protection requirements. The Director serves as a senior escalation point for complex or non-standard R&D contracting matters and supports other 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, including the ability to identify and 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, including the ability to recognize when specialized Privacy counsel should be engaged.
Excellent drafting and negotiation skills, including the ability to address complex and non-standard contractual issues efficiently.
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 the 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-improvement opportunities and develop scalable legal tools, templates, and approaches.
Excellent written and verbal communication skills, including the ability to explain complex legal issues to stakeholders with varying levels of legal expertise.
Self-starter who takes ownership while knowing when to engage subject-matter experts or escalate significant issues.
High degree of integrity, professionalism, accountability, and commitment to quality.

Nice To Haves

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 data 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, clinical and research data, and interactions with research partners.
Draft, negotiate, and advise on clinical trial, CRO, clinical vendor, research, consulting, confidentiality, data-use, and other R&D agreements.
Partner with R&D stakeholders to structure arrangements and balance legal, regulatory, and privacy risk with scientific, operational, and business objectives.
Identify, assess, and communicate material legal risks and provide actionable recommendations for mitigation and resolution.
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 legal 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 data protection requirements.
Partner with Legal and R&D stakeholders to address novel or complex legal issues and drive timely resolution.
Serve as a senior escalation point for complex or non-standard R&D contracting matters and guide contracts professionals and other Legal organization members.
Develop and improve contract templates, playbooks, guidance, and other legal resources for efficient, consistent, and scalable R&D support.
Identify opportunities to streamline legal and contracting processes, clarify roles and decision rights, and leverage standardized approaches and technology.
Provide training and education on contracting, clinical research, data privacy, and other relevant legal topics.
Monitor legal, regulatory, and industry developments relevant to research and clinical development and advise stakeholders about potential 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 environmental protection, injury prevention, and continual improvement of EHS management systems; identify hazards, report incidents, and participate in EHS initiatives and training.