Contracts Counsel The candidate will draft, review, and negotiate clinical trial agreements and confidentiality agreements with clinical sites and investigators within and outside of the United States and provide guidance to Firms Clinical Operations teams and CROs regarding processes and complex contract issues. Will draft, review, and negotiate contracts with CROs and other suppliers, such as confidentiality agreements, consulting agreements, services agreements, material transfer agreements, hardware and software license agreements, local representative/importer agreements and other agreements to support the execution of clinical trials. Lead the ongoing efforts to streamline Firms clinical contracting function by developing contract templates for various regions/countries, updating guidance documents to reflect new laws and trends, and creating efficient, scalable processes that will ensure the consistent, timely delivery of high-quality, compliant agreements. Provide legal support to the Clinical Operations and CRO teams on various matters related to master, country-level, and site-specific informed consent forms, including template development and management, creation and review of fallback documents, and guidance on key legal/privacy issues. Establish strong, collaborative relationships with Clinical Operations and other R&D teams to support training and education on company policies and good contracting practices. Advise internal clients on contract interpretation, risks, and dispute resolution matters by providing clear, practical, and business-oriented guidance. Ensure contractual documents are processed and appropriately maintained in the company's contracts management system. Occasionally provide support for non-clinical contracting needs.
The candidate should have Juris Doctor (J.D.) from an ABA-accredited law school and membership in at least one state Bar. Must have 5+ years of experience negotiating life sciences contracts at a law firm, pharmaceutical/biotech company, or CRO; strong preference for 2+ years at a pharmaceutical/biotech company. Thorough knowledge of international clinical trials and related agreements, including commonly negotiated terms related to confidentiality, intellectual property, liability, insurance, regulatory issues, and data protection/data privacy issues is required. Experience interacting with academic, research, non-profit, and government hospitals globally is needed. Knowledge of regulatory requirements and related compliance measures plus. Knowledge and familiarity with commercial, market access, and payer agreements and issues plus. Experience in process development, process improvement, and leading/managing teams is required.
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