Major Gifts Officer

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

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?

The Sr. Associate Counsel, Commercial position is a unique opportunity for a commercial attorney at a highly dynamic company. This position will report to the VP, Legal & Chief Compliance Officer at Akebia Therapeutics, Inc. (Akebia).

This position will provide strategic legal advice as a commercial attorney and Compliance advisor across the Commercial and Medical Affairs Departments. As a key advisor and resource, the individual must have the appropriate level of business acumen and legal experience to advise the business on complex legal matters.

• Serve as a commercial attorney and provide strategic legal advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA), its implementing regulations and additional FDA guidance, the PhRMA Code, state laws, antitrust laws, and federal and state transparency laws.
• Support the continued development, optimization, and operation of Akebia’s Compliance program, including policy development, training, monitoring and auditing, and other relevant day-to-day activities.
• Draft, negotiate, review, and interpret business agreements, including agreements with Akebia’s vendors, health care professionals, dialysis organizations, specialty pharmacies, payor agreements, distributor agreements, sponsorship and grant and donation agreements.
• Ensure promotional and non-promotional initiatives, advisory board proposals, speaker programs, and medical education initiatives comply with federal and state laws, including anti-kickback, false claims, FDCA, and privacy laws.
• Provide legal advice on brand/strategic planning and business operation plans, including promotional speakers’ bureaus, sponsor ships, educational grants and donations.
• Serve as a strategic business partner and provide proactive legal support to designated business areas, such as Sales, Marketing, Market Access, Patient Support, Information Technology (IT), Commercial Operations and Medical Affairs.
• Assist with conducting internal legal and compliance investigations, inclusive of reviewing documents, interviewing witnesses, providing remedial recommendations, and drafting summary memoranda.
• Work with outside counsel as needed.
• Stay abreast of industry law changes and inform business of the same.

Basic Qualifications

• JD required with 3+ years of experience working in private practice and/or in-house within the pharmaceutical industry.
• In good standing in Massachusetts Bar.

Preferred Qualifications

• Experience drafting and negotiating complex commercial agreements – experience with trade, distribution and market access contracting a plus.
• Working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including without limitation the federal and state anti-kickback and false claims act, the FDCA, federal and state transparency laws, and the PhRMA Code.
• Experience working with or for firms in the pharmaceutical, biotechnology, or medical device industry, providing advice on marketing (advertising, promotion, labeling) and sales issues, including FDA promotion, anti-kickback, and fraud and abuse matters.
• Excellent problem solving and analytical skills.
• Curious and excited at opportunity for broad exposure to new areas
• Exceedingly detail oriented and organized.
• Flexible and solution-oriented.
• High ethical standards and integrity.
• Excellent communication skills and the ability to communicate complex concepts in ways that are understood and actionable by cross-functional teams…