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Corporate Counsel, Global R&d
Refer job# LLKP161987
 
Corporate Counsel, Global R&D - Remote The candidate reports to the VP and Associate General Counsel for Global R&D and is accountable for advising and collaborating with the global business on a broad range of Global R&D and Global Quality-related activities, including research and development, manufacturing, pharmacovigilance and drug safety, regulatory engagement strategy, and compliance with R&D-related regulations, including all applicable GxP requirements. As a dedicated strategic legal partner, this person interacts with leadership and other stakeholders from various cross-functional teams and has client responsibility on a broad range of Global R&D and Global Quality-related activities and research and clinical development programs from early to late stage. Ideal candidates have strong leadership skills and extensive experience providing R&D-related legal support in the areas noted and advising business stakeholders in all levels of an organization, including senior and executive management, as well as the ability to lead and/or play a significant role in special projects and on cross-functional teams dealing with complicated legal issues. The type of strategic counseling required at this level requires the ability to use wide-ranging experience to resolve complex strategic issues in creative and effective ways with minimal direct oversight, together with an appreciation of the immediate and long-term impact that legal decisions may have on the overall global business. Key Job Responsibilities:Provide (non-IP) legal advice and counsel on issues impacting clinical research and development such as informed consent, CRO arrangements, patient recruitment activities, contract arrangements with investigators, clinical research vendors, and other collaborative research groups, IND submissions, CMC and GxP matters, and many other legal aspects of regulatory compliance involved in R&D activities. Intellectual property advice and counsel is not in scope for this role; Utilize strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives; Review, interpret, negotiate, and draft various clinical study-related agreements, technology transfers, and licensing agreements with academic institutions and strategic partners; Create and deliver effective training and other presentations to stakeholders and other members of the department on legal topics and other relevant subjects; Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents; Serve as part of matrixed teams involved in R&D-related activities and collaborate effectively, find common ground, and build alignment with relevant stakeholders; Partner with other members in the Legal and Compliance Departments to ensure consistency in approach across areas of the overall business; Contribute to strategic planning with partners and colleagues to optimize the implementation of clinical studies and other medical research activities; Keep informed of new laws, regulations, and industry trends affecting the organization; Establish strong partnership relationships with global research and development teams, as well as key cross functional teams engaged in development activities characterized by a high-level of collaboration and mutual respect; Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders; Lead and drive special projects and cross-functional teams that have a broader impact on the organization; Partner with Legal Department colleagues in executing and enhancing corporate and department objectives; Create transparent and reliable lines of communication with legal department leadership and business partners, ensuring that project developments are shared in a timely manner; Review and provide feedback on proposed regulation or legislation and assess impact on business operations; and Define, direct, and manage the work of outside counsel and other legal vendors.

The candidate should have U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction. Should have 7+ years of legal experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both. Must have experience advising clients on FDA regulatory compliance, GxP, and other matters relating to clinical trials and research and development activities. Should have understanding of pharmaceutical industry and regulatory enforcement environment, including fluency in understanding of anti-kickback laws, fraud and abuse laws, and regulations and regulatory guidance by the U.S. Food & Drug Administration and other regulatory authorities relating to clinical trials, medical activities, pharmacovigilance, manufacturing, and regulatory interactions. Must have ability to execute all aspects of role independently with little supervision and with the highest integrity and ethics. Must be a strong collaborator and adept at understanding the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for proposals/recommendations. Must consistently demonstrate leadership behaviors and ability within the Global R&D Legal team, the Legal Department, and within the broader organization.
 
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