Associate Director, Compliance

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product for the treatment of irritable bowel syndrome with constipation (IBS-C) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.


Associate Director, Compliance

Purpose of this role:

Reporting to the Vice President, Legal and Chief Compliance Officer, the Associate Director will support the design, implementation, and enhancement of Ardelyx’s compliance program and its compliance operations. The Associate Director will provide counseling to the business on a variety of areas within a highly regulated environment, including providing legal advice and counsel on advertising and promotion strategies and participating in promotional review.

The Associate Director will work closely with business colleagues on the Commercial, Medical Affairs, Finance, Human Resources, and Legal teams to sustain Ardelyx’s strong ethical culture and ensure adherence to the Company’s Code of Conduct and related rules, policies, and procedures. The Associate Director will also focus on supporting the company’s auditing and monitoring program.

We are seeking an experienced compliance professional with 5 years of relevant pharmaceutical industry experience. This position reports directly to the Vice President, Legal and Chief Compliance Officer, and is based in Waltham, MA.

Position Responsibilities: 

• Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
• Provide sound legal guidance on advertising and promotional strategies and tactics by participating the Company’s Promotional Review Committee
• Ensure that interactions with health care professionals and patients comply with applicable legal requirements and company policies
• Analyze advisory board proposals, speaker programs, and medical education initiatives for fraud and abuse, FDA, and other regulatory compliance
• Support the implementation of a robust privacy program and help pull through privacy requirements
• Ensure client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, and FDA requirements
• Support the implementation and maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligations
• Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
• Execute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment
• Travel required
• Other responsibilities as may be assigned from time to time in the company’s discretion

Position Requirements:

Candidates for the position should have the following: JD preferred, 5 years of experience working within the pharmaceutical industry or as outside counsel within a law firm providing advice to a pharmaceutical company, experience with counseling business leaders, and a strong understanding of the operational requirements for a compliance program in the pharmaceutical industry.

 The successful candidate will possess the following attributes:

• Minimum of 5 years of ethics, compliance and/or legal experience in a law firm or in a Commercial stage organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
• Experience in pharmaceutical, biotech, healthcare or medical device industries is preferred
• Experience developing, implementing, and monitoring a compliance program
• Experience with metrics used to measure success of the compliance program
• Demonstrated experience identifying and resolving compliance issues
• Demonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel on a broad range of matters
• Ability to manage multiple tasks simultaneously and to flourish in a fast-paced and high energy environment
• Able and eager to work independently and to manage and oversee discrete areas of responsibility with limited direct supervision
• Excellent organization, communication and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks
• Experience with transparency reporting and data privacy a plus

The anticipated annualized base pay range for this full-time position is $189,000 to $231,000.  Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.  Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity.  The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

 Ardelyx also offers a robust benefits package to employees, including a 401(k) plan, equity incentive plans, health plans (medical, prescription drug, dental, and vision) and basic life insurance and disability, as well as up to 10 hours of paid vacation per month, and at least 10 paid holidays.

 Ardelyx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19 in accordance with CDC guidelines. Newly hired employees must be fully vaccinated prior to their employment start date.
Ardelyx is an equal opportunity employer and will provide reasonable accommodations for those unable to be vaccinated who qualify for exemption in accordance with applicable law.

Salary : $189,000 - $231,000