At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?

JOB SUMMARY

Akebia is looking for a legal professional with experience supporting clinical trials to join its growing legal team. The Senior Contracts Manager/Senior Associate Counsel, Contracts & Legal Affairs will serve as a key advisor and legal resource for Research & Development, and potentially other departments, including Manufacturing, and Regulatory. Under the supervision of the VP, Legal Affairs, this individual will work with the business to identify and mitigate legal, operational, and business risk and to draft/review, negotiate, and interpret a variety of contracts.

SKILLS & EXPERIENCE

Basic Qualifications

• Bachelor’s degree required with 7+ years of professional experience or JD with 4+ years of professional experience
• At least 4 years of direct experience drafting and negotiating contracts
• Experience advising and supporting clinical operations within pharmaceutical, biotech, hospital, or other life science organizations to meet clinical study timelines
• Advanced redlining skills with outstanding attention to detail
• Ability to identify business, operational, and legal risk
• Excellent analytical, organizational, and project management skills
• Comfortable in a fast-paced, deadline-driven environment
• Capable of managing competing priorities and timelines

Preferred Qualifications

• Extensive experience negotiating CTAs and working with CRO(s)
• Demonstrated expertise supporting research and development and/or manufacturing/supply chain functions
• Previous experience working with Conga Contracts or similar contracts management software
• Extensive knowledge of relevant laws, regulations, guidance, and industry codes
• Proven ability to create new processes and workflow
• Excellent communication skills and the ability to communicate complex concepts in ways that are understood and actionable by cross-functional teams (e.g., translating complex requirements into practical suggestions and real-world solutions)
• Ability to cultivate strong stakeholder relationships and successfully influence leadership and peers in a fast paced, innovative business environment
• Independent judgment, tact, diplomacy and professionalism
• Self-motivated and able to perform role independently, with a minimum level of supervision
• Working knowledge and understanding of GxP and data privacy laws

• Provide dedicated support for the day to day contracting needs for a Clinical Operations team initiating and managing multiple high profile clinical trials. This includes attending regular clinical study team meetings to gain a comprehensive understanding of needs and timelines, to identify and address legal and compliance risks, and to find solutions to mitigate these risks, and participating in regular calls with contract research organizations (CROs) and other external parties.
• Draft, review, interpret, and negotiate a wide variety of agreements, including confidential disclosure agreements, master services agreements, clinical trial agreements (CTAs), clinical supply/logistics agreements, consulting agreements, quality agreements, and statements of work.
• Manage the contract process from beginning to end. This includes communicating and corresponding with internal clients, vendors, and other stakeholders, drafting contract terms, negotiating with external parties, and ensuring proper tracking, execution, and filing of contracts within contracts management database.
• Support continued development, optimization, and operation of a comprehensive contracts process for all Akebia departments and assume responsibility for organization and management of the contracts management database.
• Assist with updating/maintaining contract templates and library of approved terms.
• Support contracting needs for other assigned departments as needed, including Manufacturing, Supply Chain, and Regulatory.
• Work with outside counsel as needed.
• Stay abreast of industry law changes and inform business of the same.