Description:

A Growing Biopharmaceutical Company is looking for a VP, Legal & Chief Compliance Officer to join its fast-paced and collaborative legal and compliance team. The VP, Legal & Chief Compliance Officer will be principally responsible for the continued improvement and implementation of the company's Compliance Program. The VP, Legal & Chief Compliance Officer will report to the SVP, Legal & General Counsel. This is an exciting opportunity to work with other members of the legal team and across the organization to ensure that the compliance program is executed appropriately and gain exposure to a wide variety of business and legal issues at a commercial stage biotech company.

The Chief Compliance Officer will:

Lead Akebia's Compliance Program- continue to refine and improve it in accordance with developing industry guidance and trends, as well as the particular business needs and risks of Akebia. Ensure the Compliance Program is effectively integrated into the culture and business operations at Akebia.
Strategic legal and compliance partner- provide strategic 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) laws, federal and state transparency laws (e.g., Open Payments), the PhRMA Code, state laws, and antitrust laws.
Act as Chair of Compliance Committee, a management-level committee responsible for the management and oversight of the Compliance Program at Akebia.
Provide quarterly updates on the Compliance Program to the Audit Committee of the Board of Directors.
Support government pricing by providing strategic legal advice to ensure compliance with federal and state government pricing laws.
Serve as voting member of Pricing Committee, a committee that approves drug price increases, discounts and rebates for payors, PBMs and wholesalers.
Manage and oversee commercial and privacy attorney.
Review business strategy plans and business development opportunities for legal and compliance risks and advise the business on how to mitigate those risks.
Develop and maintain trusting relationships with sales and other field personnel; serve as a trusted advisor and resource.
Develop compliance and legal training curriculum and conduct training at sales meetings and other company meetings on compliance policies and legal and compliance matters.
Provide strategic legal and compliance input on critical agreements for Akebia, including business development opportunities, pharmacy, PBM and wholesaler agreements.
Act as compliance champion to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel through effective engagement, training, auditing, and monitoring.
Manage and conduct compliance investigations into alleged violations of the Compliance Program working with internal business partners to identify appropriate corrective actions as needed.
Conduct periodic risk assessment and develop mitigation plans as needed, and communicate results to Company leadership.
Develop and oversee plans for monitoring the Company's commercial and medical affairs activities.
Oversee federal and state transparency reporting with outside vendors preparing and mitigating reports.

Basic Qualifications:

Juris Doctor degree plus minimum 10 years of pharmaceutical or biotech experience in compliance and/or commercial legal role.
Comprehensive knowledge of U.S. healthcare fraud and abuse laws, FDA, OIG, FCPA, and CMS regulations, rules and guidance's, pharmaceutical marketing, price reporting, privacy, federal and state disclosure requirements.
Working knowledge of federal and state government pricing laws.

Preferred Qualifications:

Experience in drafting and negotiating a range of agreements, such as distribution and pharmacy, payor and provider discount arrangements a plus.
Strong management skills.
Business focused and solution oriented.
Ability to effectively manage outside counsel and budget.
Excellent problem solving and analytical skills.
Ability to cultivate strong stakeholder relationships and communicate complex concepts in ways that are understood and actionable by cross-functional teams (e.g., translate complex requirements into practical suggestions and real-world solutions).
Self-motivated and able to perform role independently, with a minimum level of supervision.
Outstanding attention to detail and ability to identify business, legal and compliance issues.
Strong written and verbal communication skills.
Strong organizational and project management skills with an ability to work in a fast-paced, innovative and collaborative environment.