Director Transactional Law

Profile

Seattle Genetics Careers
Responsibilities: Strategic oversight of Clinical Contracts team by leading a team of attorneys and paralegals to provide legal support to Research & Development, by (i) negotiating, drafting, and counseling on agreements and other documents relating to the research and development of pharmaceutical products, including sponsored research agreements and clinical trial agreements, and (ii) collaborating and interfacing with other internal groups (such as Compliance, Regulatory Affairs, etc.) to ensure compliance with applicable laws, regulations, and policies. Evaluate current state of team process and develop and implement new process that has the ability to scale and create efficiencies for the team while also increasing the experience of key stakeholders and external partners. Develop and maintain clinical trial agreement and related templates and negotiation guidelines to facilitate balanced and efficient contracting at scale. Key member of miscellaneous cross-functional teams addressing Clinical, Regulatory and Compliance issues. Collaborate with other members of Transactional Law to align processes across business groups. Identifying and providing counsel and/or triage to appropriate internal or external resources, on legal issues related to clinical trials (including GCP, recruiting subjects, informed consent, conflicts of interest, data transparency, pharmacovigilance, publications, study subject injury and privacy), FDA and EMA regulatory review processes, compassionate use, compliance investigations and animal research. Build strategic collaborative relationships with major clinical trial sites and CROs. Develop trusted adviser relationship with Clinical Development Operations and other clients/stakeholders. Work creatively and analytically in a problem-solving environment to resolve issues, manage transactional risk and bring transactions to an acceptable close. Interfaces with external legal resources, as needed. Hire and develop talent to build a high-performing team who consistently delivers on goals and key initiatives. Other responsibilities as assigned.

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