Global R&D Legal Strategy Director

BioSpace; San Rafael (CA); On-site; USD 230,000 - 350,000; Full time

Job summary

BioMarin is seeking a Director, Corporate Counsel, R&D to serve as a strategic legal partner to Worldwide Research and Development. This role provides practical, business-focused legal counsel across the development lifecycle, including research activities, global clinical trials, data privacy, and contracting matters.

The successful candidate will advise cross-functional teams, draft and negotiate complex agreements, and help develop scalable legal processes to support evolving R&D needs while

Qualifications

• 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, preferably including experience in the biotechnology or pharmaceutical industry and/or a law firm advising life sciences clients.
• 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. Experience with clinical trial agreements, CRO and clinical vendor agreements, research agreements and other agreements supporting R&D activities strongly preferred.
• Experience advising on data privacy and data protection issues arising in clinical research and drug development, including the collection, use, sharing and transfer of clinical trial, patient and research data.

Responsibilities

• Serve as a primary legal advisor to assigned R&D functions, programs and teams, providing strategic, practical and solutions-oriented counsel on legal matters arising 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 clinical trial conduct, informed consent, data privacy and the collection, use, disclosure and transfer of clinical, patient and research data, research activities and interactions with clinical research organizations, investigators, hospitals, universities and other research partners.
• Draft, negotiate and advise on a broad range of agreements supporting R&D activities, including clinical trial agreements, CRO and clinical vendor agreements, research and consulting agreements, confidentiality agreements, data use and data-related agreements, and other agreements supporting global research and development activities.
• Partner with R&D stakeholders to structure arrangements and develop practical solutions that appropriately balance legal, regulatory and privacy risk with scientific, operational and business objectives.
• Independently identify, assess and communicate material legal risks and provide clear, actionable recommendations to R&D leaders and other appropriate decision-makers regarding risk mitigation and resolution.

Skills

Legal judgment

Cross-functional collaboration

Data privacy

Contract drafting

Pharma/biotech regulatory

In-house counsel

Communication skills

Education

Juris Doctor (J.D.)

CA Bar eligibility

8+ years of legal experience

Job description

BioMarin is seeking a Director, Corporate Counsel, R&D to serve as a strategic legal partner to Worldwide Research and Development. This role provides practical, business-focused legal counsel across the development lifecycle, including research activities, global clinical trials, data privacy, and contracting matters.

The successful candidate will advise cross-functional teams, draft and negotiate complex agreements, and help develop scalable legal processes to support evolving R&D needs while