Director, Corporate Counsel, R&D San Rafael, United States Hybrid

Job description

Back to Jobs San Rafael BioMarin Pharmaceutical Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Corporate Groups It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations. Director, Corporate Counsel, R&D Summary / Job Purpose The Director, Corporate Counsel, R&D will serve as a strategic legal partner to Worldwide Research and Development (WWRD), providing practical, business-focused legal counsel in support of global research and clinical development activities. This role will independently advise R&D leaders and cross-functional teams on legal matters arising 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 matters. The Director will identify and help manage legal risk while enabling the efficient advancement of R&D priorities. This role will partner closely with colleagues across Research, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Privacy, Compliance and other functions and will help develop scalable legal processes, contracting approaches and resources that support the evolving needs of the R&D organization. Essential Duties and 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. Review and advise on clinical trial and research-related documents, including informed consent forms, privacy notices and data-use documentation, clinical trial submission materials and other documents presenting legal issues. Provide legal guidance regarding applicable laws, regulations and industry standards governing clinical research and development, including FDA and EMA requirements, ICH Good Clinical Practice, applicable data privacy and data protection requirements, and other requirements relevant to global R&D activities, partnering with Privacy, Regulatory, Compliance and other Legal colleagues as appropriate. Partner effectively across Legal and with R&D stakeholders to address novel or complex legal issues and drive timely resolution of matters that could impact research or development activities. Serve as a senior escalation point for complex or non-standard R&D contracting matters and provide guidance to contracts professionals and other members of the Legal organization. Develop and continuously improve contract templates, playbooks, guidance and other legal resources to promote efficient, consistent and scalable support for R&D activities. Identify opportunities to streamline legal and contracting processes, including clarifying roles and decision rights among attorneys, contracts professionals and business partners and appropriately leveraging 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 within the attorney’s area of responsibility. Monitor developments in laws, regulations and industry practices relevant to research and clinical development and advise appropriate stakeholders regarding their potential impact on the organization and its activities. Promote strong 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. Education and Experience 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. Knowledge of laws, regulations and industry standards applicable to clinical research and drug development, including FDA and EMA regulatory frameworks, ICH Good Clinical Practice, and data privacy and data protection requirements relevant to global clinical research, strongly preferred. Experience advising cross-functional teams and working effectively within a complex, global and highly matrixed organization preferred. Knowledge, Skills and Capabilities Demonstrated ability to operate independently and serve as a trusted legal advisor to business and functional leaders. Excellent legal judgment and ability to identify and assess legal risk, distinguish material risks from manageable business risks, and recommend practical solutions that appropriately protect the company while enabling R&D objectives. Strong understanding of the legal and regulatory environment appl