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Associate Director, Clinical Contracts Counsel

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🔥 0 minutes ago

☕ Washington – Remote

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💵 $205k - $226k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Logo of Umoja Biopharma

Umoja Biopharma

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $210M Series B on 2021-06

Healthcare • Consulting • Manufacturing

Umoja Biopharma is a pioneering biopharmaceutical company focused on developing innovative in vivo CAR T cell therapies for cancer treatment. Their flagship technology, the VivoVec platform, enables the generation of CAR T cells directly within a patient's body, significantly streamlining the process compared to traditional ex vivo methods. Umoja Biopharma is dedicated to enhancing patient care by making cancer treatments more accessible and effective, backed by their own in-house manufacturing capabilities that ensure quality and reliability in their therapeutic production.

📋 Description

• Draft, review, and negotiate clinical trial agreements, confidentiality agreements, master services agreements, ancillary contracts, consulting agreements, and informed consent forms • Develop clear, practical, and risk-balanced contract terms supporting business objectives • Customize contract structures and terms while maintaining company standards • Review and analyze contracts for legal risks, compliance considerations, and business implications • Partner with internal stakeholders to understand operational objectives and provide guidance on contractual rights, obligations, and risk trade-offs • Ensure contracts align with company policies, legal requirements, and strategic priorities, escalating complex or high-risk issues as appropriate • Provide practical, business-focused legal advice on contract-related matters • Advise on intellectual property, indemnification, limitation of liability, confidentiality, and other contractual issues • Develop and deliver training materials, guidance, and presentations on contract processes, policies, and best practices • Monitor contractual obligations to support compliance with agreed terms and conditions • Collaborate with cross-functional partners to implement contract compliance processes and mitigate legal and operational risk • Assist with internal audits, issue resolution, and continuous improvement of contracting practices • Support contract lifecycle management, contract templates, clause libraries, negotiation playbooks, standardized processes, and workflow optimization • Report to the Chief Legal Officer and collaborate with cross-functional teams to support clinical programs

🎯 Requirements

• J.D. from an accredited law school • Active membership in at least one U.S. state bar; Washington State bar membership preferred • Minimum of 5 years of combined law firm and/or in-house legal experience within the biotechnology, pharmaceutical, or life sciences industry • Minimum of 2 years of direct experience serving as a contracts attorney with responsibility for drafting and negotiating clinical trial agreements • Experience supporting clinical operations contracting and negotiating clinical trial agreements, confidentiality agreements, master service agreements, consulting agreements, and informed consent forms (ICFs) • Strong understanding of contract law, U.S. and ex-U.S. clinical study frameworks, and applicable regulatory requirements • Ability to identify and assess legal and business risks and provide practical, solutions-oriented guidance • Excellent analytical, communication, negotiation, stakeholder management, and relationship-building skills • Ability to manage multiple priorities, work independently, and thrive in a fast-paced, evolving biotechnology environment • Collaborative, client-service-oriented approach with ability to build trusted partnerships across Clinical Operations, Regulatory Affairs, Procurement, Finance, and other cross-functional teams • Experience supporting contract lifecycle management (CLM) systems, developing contract templates, clause libraries, negotiation playbooks, and standardized contracting processes • Experience leading or supporting legal operations, contract process improvement, and workflow optimization initiatives • Experience within a clinical-stage or commercial-stage biotechnology, pharmaceutical, or life sciences organization • Ability to sit for extended periods of time • Ability to do typical desk work in an office environment

🏖️ Benefits

• Medical plans • Dental plans • Vision plans • 401k plan through Fidelity, with a 100% match up to the first 4% deferral • Generous Paid Time Off policy • Employee commuter benefits • Cell phone stipend

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